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Trial Review
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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04644068
Registration number
NCT04644068
Ethics application status
Date submitted
26/10/2020
Date registered
25/11/2020
Date last updated
25/06/2024
Titles & IDs
Public title
Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies
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Scientific title
A Modular Phase I/IIa, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies
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Secondary ID [1]
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0
2020-002688-77
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Secondary ID [2]
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0
D9720C00001
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Universal Trial Number (UTN)
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Trial acronym
PETRA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer
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0
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Breast Cancer
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0
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Pancreatic Cancer
0
0
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Prostate Cancer
0
0
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Additional Indications Below for Module 4 and 5
0
0
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Non-small Cell Lung Cancer
0
0
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Colorectal Cancer
0
0
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Bladder Cancer
0
0
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Gastric Cancer
0
0
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Biliary Cancer
0
0
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Cervical Cancer
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0
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Endometrial Cancer
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0
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Small Cell Lung Cancer Only in Module 5
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0
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Condition category
Condition code
Cancer
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0
0
0
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Lung - Mesothelioma
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Cancer
0
0
0
0
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Lung - Non small cell
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Cancer
0
0
0
0
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Lung - Small cell
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Cancer
0
0
0
0
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Prostate
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Cancer
0
0
0
0
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Pancreatic
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Cancer
0
0
0
0
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Ovarian and primary peritoneal
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Cancer
0
0
0
0
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Womb (Uterine or endometrial cancer)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AZD5305
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Carboplatin
Treatment: Drugs - T- Dxd
Treatment: Drugs - Dato-DXd
Treatment: Drugs - Camizestrant
Experimental: Module 1: AZD5305 Monotherapy - AZD5305 Monotherapy
Experimental: Module 2: AZD5305 + Paclitaxel - AZD5305 + Paclitaxel
Experimental: Module 3: AZD5305 + Carboplatin with or without Paclitaxel - AZD5305 + Carboplatin with or without Paclitaxel
Experimental: Module 4: AZD5305 + Trastuzumab Deruxtecan - AZD5305 + T- DXd
Experimental: Module 5 AZD5305 + Datopotamab Deruxtecan - AZD5305 + Dato-DXd
Experimental: Module 6 AZD5305 + Camizestrant - AZD5305 + Camizestrant
Treatment: Drugs: AZD5305
Oral PARP inhibitor
Treatment: Drugs: Paclitaxel
IV Anti-microtubule agent
Treatment: Drugs: Carboplatin
IV Platinum chemotherapeutic
Treatment: Drugs: T- Dxd
IV Antibody-drug conjugate
Treatment: Drugs: Dato-DXd
IV Antibody-drug conjugate
Treatment: Drugs: Camizestrant
Oral SERD Molecule
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The number of subjects with adverse events/serious adverse events
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Assessment method [1]
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Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal ECG parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline
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Timepoint [1]
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From time of Informed Consent to 28 + 7 days post last dose ( modules 1,2,3,5 and 6). 40+7 days post last dose for Module 4.
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Primary outcome [2]
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The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol.
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Assessment method [2]
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A DLT is defined as any toxicity that occurs from the first dose of study treatment (either AZD5305 or combination anti-cancer agent) up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation. DLTs occurring outside the DLT window (ie, late onset toxicities) may be defined as a DLT after consultation with the sponsor and investigators, based on the emerging safety profile.
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Timepoint [2]
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From first dose of study treatment until the end of Cycle 1.
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Secondary outcome [1]
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Best percentage change in target lesion
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Assessment method [1]
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Change in target lesion size from baseline, as defined by RECIST 1.1.
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Timepoint [1]
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From Screening to confirmed progressive disease (approximately 1 year)
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Secondary outcome [2]
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Objective Response Rate
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Assessment method [2]
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Best response until progression, as defined by RECIST 1.1.
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Timepoint [2]
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From Screening to confirmed progressive disease (approximately 1 year)
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Secondary outcome [3]
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Duration of Response
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Assessment method [3]
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Time from first response to progression or death , as defined by RECIST 1.1.
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Timepoint [3]
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From Screening to confirmed progressive disease (approximately 1 year)
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Secondary outcome [4]
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Progression Free Survival
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Assessment method [4]
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Time from C1D1 to progression or death, as defined by RECIST 1.1.
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Timepoint [4]
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From Screening to confirmed progressive disease (approximately 1 year)
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Secondary outcome [5]
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Time To Response
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Assessment method [5]
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Time from C1D1 to complete or partial response, as defined by RECIST 1.1.
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Timepoint [5]
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From Screening to confirmed progressive disease (approximately 1 year)
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Secondary outcome [6]
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Effects of AZD5305 on pH2AX (Ser139) PD biomarker
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Assessment method [6]
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Measure change from baseline in pH2AX
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Timepoint [6]
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From Cycle 0 Day 1 to Cycle 1 Day 15 (approximately 21 days)
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Secondary outcome [7]
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CA125 response (ovarian cancer)
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Assessment method [7]
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at least a 50% reduction in CA125 levels from a pre-treatment sample as defined by GCIG criteria.
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Timepoint [7]
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From Screening to confirmed progressive disease (approximately 1 year)
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Secondary outcome [8]
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Module 1: Area Under Curve (AUC)
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Assessment method [8]
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The concentration of AZD5305 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.
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Timepoint [8]
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At predefined intervals throughout the treatment period (approximately 12 weeks)
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Secondary outcome [9]
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Module 1: Maximum plasma concentration of the drug (Cmax)
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Assessment method [9]
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The concentration of AZD5305 in plasma will be determined (Cmax will be derived).
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Timepoint [9]
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At predefined intervals throughout the treatment period (approximately 12 weeks)
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Secondary outcome [10]
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Module 1: The time taken to reach the maximum concentration (Tmax)
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Assessment method [10]
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The concentration of AZD5305 in plasma will be determined (Tmax will be derived).
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Timepoint [10]
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At predefined intervals throughout the treatment period (approximately 12 weeks)
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Secondary outcome [11]
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Module 1 and Module 5: Objective Response Rate (prostate cancer)
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Assessment method [11]
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Best response until progression, as defined by RECIST 1.1 or PCWG3 (bone)
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Timepoint [11]
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From Screening to confirmed progressive disease (approximately 1 year)
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Secondary outcome [12]
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Module 1: Radiographic progression free survival (prostate cancer)
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Assessment method [12]
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Time from C1D1 to progression or death, as defined by RECIST 1.1 and PCWG3(bone).
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Timepoint [12]
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From Screening to confirmed progressive disease (approximately 1 year)
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Secondary outcome [13]
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Module 1: Proportion of subjects with = 50% PSA decrease (prostate cancer)
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Assessment method [13]
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PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment
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Timepoint [13]
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From Screening to confirmed progressive disease (approximately 1 year)
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Secondary outcome [14]
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Module 1 : To investigate the effect of a high-fat meal on the PK of AZD5305
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Assessment method [14]
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Effect on High fat meal on PK parameters of AZD5305.PK parameters, including but not limited to AUC and/or AUC(0-t), Cmax, Tmax, AUC(0-t) and Cmax ratio, with and without food
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Timepoint [14]
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Cycle 0, Day 1 (C0D1), in either the "fasted" or "fed" state, followed by a single oral dose of AZD5305 in the other state for Cycle 1, Day 1 (C1D1) at least 72 hours later; 1 cycle is 28 days.
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Secondary outcome [15]
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Module 2: Area Under Curve (AUC)
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Assessment method [15]
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The concentration of AZD5305 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.
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Timepoint [15]
0
0
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Secondary outcome [16]
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0
Module 2: Maximum plasma concentration of the drug (Cmax)
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Assessment method [16]
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The concentration of AZD5305 in plasma will be determined (Cmax will be derived).
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Timepoint [16]
0
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At predefined intervals throughout the treatment period (approximately 12 weeks)
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Secondary outcome [17]
0
0
Module 2: The time taken to reach the maximum concentration (Tmax)
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Assessment method [17]
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0
The concentration of AZD5305 in plasma will be determined (Tmax will be derived).
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Timepoint [17]
0
0
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Secondary outcome [18]
0
0
Module 3: Area Under Curve (AUC)
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Assessment method [18]
0
0
The concentration of AZD5305 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.
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Timepoint [18]
0
0
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Secondary outcome [19]
0
0
Module 3: Maximum plasma concentration of the drug (Cmax)
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Assessment method [19]
0
0
The concentration of AZD5305 in plasma will be determined (Cmax will be derived).
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Timepoint [19]
0
0
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Secondary outcome [20]
0
0
Module 3: The time taken to reach the maximum concentration (Tmax)
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Assessment method [20]
0
0
The concentration of AZD5305 in plasma will be determined (Tmax will be derived).
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Timepoint [20]
0
0
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Secondary outcome [21]
0
0
Module 4 : Area Under Curve
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Assessment method [21]
0
0
The concentration of AZD5305 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.
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Timepoint [21]
0
0
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Secondary outcome [22]
0
0
Module 4: Maximum plasma concentration of the drug (Cmax)
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Assessment method [22]
0
0
The concentration of AZD5305 in plasma will be determined (Cmax will be derived).
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Timepoint [22]
0
0
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Secondary outcome [23]
0
0
Module 4: The time taken to reach the maximum concentration (Tmax)
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Assessment method [23]
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0
The concentration of AZD5305 in plasma will be determined (Tmax will be derived).
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Timepoint [23]
0
0
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Secondary outcome [24]
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0
Module 4: Anti-Drug Antibody (ADA)
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Assessment method [24]
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0
To investigate the presence of ADAs for T-DXd
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Timepoint [24]
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Samples will be collected within 1 hour before dose administration on Day 1 of Cycle 1, 2, and 4, then every 4 Cycles (each cycle is 21 days), EoT, and at safety follow-up (40 days after last dose) as per Schedule of Assessments
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Secondary outcome [25]
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Module 4: To assess the preliminary anti-tumour activity of AZD5305 as monotherapy and in combination with T-DXd.
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Assessment method [25]
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Time from C1D1 to progression or death, as defined by RECIST v 1.1 summarised at the 6 month landmark (PFS6)
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Timepoint [25]
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0
From screening to approximately 6 months
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Secondary outcome [26]
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Module 5: Area Under Curve
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Assessment method [26]
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The concentration of AZD5305 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.
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Timepoint [26]
0
0
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Secondary outcome [27]
0
0
Module 5: Maximum plasma concentration of the drug (Cmax)
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Assessment method [27]
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The concentration of AZD5305 in plasma will be determined (Cmax will be derived).
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Timepoint [27]
0
0
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Secondary outcome [28]
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Module 5: The time taken to reach the maximum concentration (Tmax)
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Assessment method [28]
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The concentration of AZD5305 in plasma will be determined (Tmax will be derived).
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Timepoint [28]
0
0
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Secondary outcome [29]
0
0
Module 5: Anti-Drug Antibody (ADA)
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Assessment method [29]
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Presence of ADAs for Dato-DXd
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Timepoint [29]
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Whole blood samples for determination of ADA for Dato-DXd in plasma will be collected in patients receiving Dato-DXd per the schedule specified in the SoA : Day 1 of Cycle 1, 2, 4, and 8 (each cycle is 21 days) , EoT, and then 28 day follow up visit.
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Secondary outcome [30]
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Module 5: Premilinary anti tumour activity AZD5305 in combination with
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Assessment method [30]
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0
objective response rate and radiographic progression-free survival using RECIST v1.1.
Proportion of patients achieving a = 50% decrease in PSA from baseline to the post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later (PSA50 response).
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Timepoint [30]
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0
From screening to confirmed progresive disease ( approximately 12 weeks)
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Secondary outcome [31]
0
0
Module 6: To characterise the PK of AZD5305 and camizestrant following a single dose and at steady state after multiple dosing, when given in combination.
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Assessment method [31]
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0
Plasma concentrations and PK parameters of AZD5305 and camizestrant after single dose and multiple dose administration, including, but not limited to:
AUC, Cmax, Tmax, as data allow
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Timepoint [31]
0
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At predefined interval throughout the treatment (approximately 12 weeks)
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Secondary outcome [32]
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Module 6: To evaluate the effect of camizestrant on the PK of AZD5305.
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Assessment method [32]
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0
PK parameters, including but not limited to AUC and/or AUC(0-t), Cmax, Tmax, AUC(0-t) and Cmax ratio, with and without camizestrant.
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Timepoint [32]
0
0
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Secondary outcome [33]
0
0
Module 6: To evaluate the effect of AZD5305 on the PK of Camizestrant.
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Assessment method [33]
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0
PK parameters, including but not limited to AUC and/or AUC(0-t), Cmax, Tmax, AUC(0-t) and Cmax ratio, with and without AZD5305.
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Timepoint [33]
0
0
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Eligibility
Key inclusion criteria
Key
* Age = 18 at the time of screening
* Histological or cytological confirmation of advanced malignancy considered to be suitable for study treatment and meeting module specific eligibility criteria..
* Eastern Cooperative Oncology Group Performance status (ECOG PS: 0-2)
* Life expectancy = 12 weeks
* Progressive cancer at the time of study entry
* Patients must have evaluable disease as defined in module-specific criteria for Part A and Part B
* Adequate organ and marrow function as defined by the protocol.
* For Part B expansion cohorts: Provision of formalin-fixed and paraffin embedded (FFPE) tumour specimen is mandatory, where available, except if stated that it is optional in a specific Module.
For Part A:
- Patients may have received up to one prior line of therapy with a PARPi-based regimen (either as a treatment or as maintenance)
For Part B:
- Patients must not have received prior therapy with a PARPi-based regimen (either as a treatment or as maintenance).
Key
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Minimum age
18
Years
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Maximum age
130
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Treatment with any of the following:
1. Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment
2. Any investigational agents or study drugs from a previous clinical study within 5 half-lives or 3 weeks (whichever is shorter) of the first dose of study treatment
3. Any other chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of study treatment
4. Any live virus or bacterial vaccine within 28 days of the first dose of study treatment
* Concomitant use of medications or herbal supplements known to be cytochrome P450 3A4 (CYP3A4) strong and moderate inhibitors or inducers.
* Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of Torsades de Pointes.
* Receiving continuous corticosteroids at a dose of >10 mg prednisone/day or equivalent for any reason.
* Major surgery within 4 weeks of the first dose of study treatment.
* Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment.
* Any history of persisting (> 2 weeks) severe pancytopenia due to any cause
* Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of >10mg prednisone/day or equivalent for at least 4 weeks prior to start of study treatment. Patients with leptomeningeal carcinomatosis are excluded.
* patient with known predisposition to bleeding (e.g., active peptic ulceration, recent [within 6 months] haemorrhagic stroke, proliferative diabetic retinopathy).
* Cardiac conditions as defined by the clinical study protocol
* Other cardiovascular diseases as defined by any of the following:
1. Symptomatic heart failure,
2. uncontrolled hypertension,
3. hypertensive heart disease with significant left ventricular hypertrophy
4. acute coronary syndrome (ACS)/acute myocardial infarction (AMI), unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 6 months.
5. cardiomyopathy of any etiology
6. presence of clinically significant valvular heart disease
7. history of atrial or ventricular arrhythmia requiring treatment; subjects with atrial fibrillation and optimally controlled ventricular rate (< 100 beats per minute) are permitted.
8. subjects with atrial fibrillation and optimally controlled ventricular rate are permitted
9. transient ischaemic attack, or stroke within 6 months prior to screening
10. patients with symptomatic hypotension at screening
* Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML).
* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305
* Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s).
Prior malignancy whose natural history, in the Investigator's opinion, has the potential to interfere with safety and efficacy assessments of the investigational regimen.
other module-specific criteria may apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/11/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
15/12/2026
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Actual
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Sample size
Target
804
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
0
0
Research Site - Heidelberg
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Recruitment hospital [2]
0
0
Research Site - Melbourne
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Recruitment postcode(s) [1]
0
0
3084 - Heidelberg
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Recruitment postcode(s) [2]
0
0
3000 - Melbourne
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Massachusetts
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Country [3]
0
0
United States of America
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State/province [3]
0
0
New York
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Oklahoma
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Texas
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Country [6]
0
0
Canada
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State/province [6]
0
0
British Columbia
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Country [7]
0
0
Canada
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State/province [7]
0
0
Ontario
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Country [8]
0
0
Canada
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State/province [8]
0
0
Quebec
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Country [9]
0
0
China
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State/province [9]
0
0
Beijing
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Country [10]
0
0
China
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State/province [10]
0
0
Changchun
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Country [11]
0
0
China
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State/province [11]
0
0
Changsha
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Country [12]
0
0
China
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State/province [12]
0
0
Chengdu
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Country [13]
0
0
China
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State/province [13]
0
0
Chongqing
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Country [14]
0
0
China
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State/province [14]
0
0
Guangzhou
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Country [15]
0
0
China
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State/province [15]
0
0
Harbin
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Country [16]
0
0
China
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State/province [16]
0
0
Jining
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Country [17]
0
0
China
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State/province [17]
0
0
Shandong
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Country [18]
0
0
China
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State/province [18]
0
0
Shanghai
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Country [19]
0
0
China
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State/province [19]
0
0
Taiyuan
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Country [20]
0
0
China
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State/province [20]
0
0
Wuhan
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Country [21]
0
0
China
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State/province [21]
0
0
Xi'an
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Country [22]
0
0
Czechia
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State/province [22]
0
0
Brno
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Country [23]
0
0
Czechia
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State/province [23]
0
0
Olomouc
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Country [24]
0
0
Czechia
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State/province [24]
0
0
Praha
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Country [25]
0
0
Hungary
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State/province [25]
0
0
Budapest
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Country [26]
0
0
Italy
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State/province [26]
0
0
Milano
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Country [27]
0
0
Italy
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Milan
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Italy
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Modena
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Italy
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Napoli
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Italy
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Padova
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Italy
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Roma
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Japan
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Chuo-ku
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Japan
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Koto-ku
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Korea, Republic of
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Seoul
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Gdynia
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Poland
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Gliwice
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Poland
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Grzepnica
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Poland
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Kraków
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Lublin
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Poland
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Torun
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Poland
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Warszawa
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Poland
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Lódz
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Russian Federation
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Moscow
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Pozuelo de Alarcon
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Spain
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Sevilla
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United Kingdom
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Cambridge
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United Kingdom
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Manchester
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United Kingdom
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Oxford
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United Kingdom
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Sutton
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Funding & Sponsors
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Commercial sector/industry
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Name
AstraZeneca
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Summary
Brief summary
This research is designed to determine if experimental treatment with PARP inhibitor, AZD5305, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.
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Trial website
https://clinicaltrials.gov/study/NCT04644068
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Public notes
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Contacts
Principal investigator
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Timothy Yap
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M.D. Anderson Cancer Center
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Contact person for public queries
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AstraZeneca Clinical Study Information Center
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Phone
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1-877-240-9479
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT04644068
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