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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05355298
Registration number
NCT05355298
Ethics application status
Date submitted
7/04/2022
Date registered
2/05/2022
Date last updated
6/03/2024
Titles & IDs
Public title
ACCENT: AMP945 in Combination With Nab-paclitaxel and Gemcitabine for Treatment of Pancreatic Cancer
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Scientific title
A Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination With Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients
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Secondary ID [1]
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AMP945-PC-201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer
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PDAC
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Pancreatic Ductal Adenocarcinoma
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Condition category
Condition code
Cancer
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Pancreatic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AMP945 ascending doses
Treatment: Drugs - AMP945 RP2D
Experimental: AMP945 - Part A: AMP945 administered in dose escalating cohorts Part B: AMP945 recommended phase 2 dose
Treatment: Drugs: AMP945 ascending doses
Part A is a phase 1b dose-escalation design that will enrol at least 3 participants in each of 4 dose-level cohorts, to determine the RP2D of AMP945 to be explored in Part B. Dose escalation decisions will be made using a standard 3+3 dose-escalation phase 1 oncology study design.
Treatment: Drugs: AMP945 RP2D
Part B will determine the efficacy of the AMP945 priming regimen at the recommended phase 2 dose (RP2D) determined in Part A.
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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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Number of Participants with Treatment-Emergent Adverse Events (TEAEs) from Baseline to End of Study
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Assessment method [1]
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TEAEs during study treatment and follow up periods
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Timepoint [1]
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From first dose of study drug to end of study, an expected average of 6 months
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Primary outcome [2]
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Part A: Determination of RP2D
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Assessment method [2]
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The RP2D of AMP945 will be determined based on either the maximum tolerated dose or maximum pharmacodynamic effect, which ever is reached first
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Timepoint [2]
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After Cycle 1 (28 days) for each Part A cohort
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Primary outcome [3]
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Part B: efficacy of AMP945
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Assessment method [3]
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Overall response rate based on RECIST 1.1
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Timepoint [3]
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Imaging every 56 days per participant, with an expected average duration of 6 months
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Secondary outcome [1]
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Part A: efficacy of AMP945
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Assessment method [1]
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Overall response rate based on RECIST 1.1
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Timepoint [1]
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Imaging every 56 days per participant, with an expected average duration of 6 months
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Secondary outcome [2]
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AMP945 levels in plasma
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Assessment method [2]
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Measurement of maximum concentration (cmax) of AMP945
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Timepoint [2]
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Days -8, -7, 1, 3, 4, 8 and 10
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Secondary outcome [3]
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AMP945 levels in plasma
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Assessment method [3]
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Measurement of time to cmax (tmax)
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Timepoint [3]
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Days -8, -7, 1, 3, 4, 8 and 10
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Secondary outcome [4]
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AMP945 levels in plasma
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Assessment method [4]
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Measurement of clearance (CL)
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Timepoint [4]
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Days -8, -7, 1, 3, 4, 8 and 10
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Eligibility
Key inclusion criteria
1. Provide written informed consent prior to any study procedures and agree to adhere to
all protocol requirements.
2. Aged at least 18 years at the time of consent.
3. Confirmed histological or cytological diagnosis of advanced pancreatic adenocarcinoma
that is:
Part A: metastatic or not surgically resectable.
Part B: metastatic, with initial diagnosis of metastatic disease =6 weeks prior to
Baseline.
4. Has measurable disease, defined as at least one lesion that can be accurately measured
in at least one dimension (longest diameter to be recorded) as >20 mm with
conventional techniques or as >10 mm with spiral CT scan.
5. Eligible for treatment with nab-paclitaxel and gemcitabine as standard of care
therapy.
6. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1, sustained on two
separate assessments: the first at least 2 weeks prior to the 1st dose of AMP945 and
the 2nd within 72 hours prior to the 1st dose of AMP945. Participants not maintaining
an ECOG Performance Score of 0-1 at the second assessment will be excluded from
participation.
7. Has a life expectancy of >3 months.
8. Adequate organ function, as defined by the laboratory results below (samples must be
obtained =14 days prior to study drug administration):
a) Haematology:
(i) Absolute neutrophil count (ANC) =1.5 × 109/L;
(ii) Platelet count =100,000/mm3 (100 × 109/L);
(iii) Haemoglobin (Hgb) =9 g/dL.
b) Serum chemistry:
(i) Aspartate transaminase (AST) (SGOT), ALT (SGPT) =2.5 × upper limit of normal range
(ULN), unless liver metastases are clearly present, then =5 × ULN is allowed;
(ii) Total bilirubin =ULN;
(iii) Creatinine <1.5 x upper limit of normal (ULN) or estimated glomerular filtration
rate (eGFR) >60 mL/min/1.73m2 (calculated using the Cockcroft-Gault equation).
c) No clinically significant abnormalities in coagulation results.
d) No clinically significant abnormalities in urinalysis results.
9. Agree to use contraception according to protocol
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Minimum age
18
Years
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Maximum age
No limit
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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
1. Pregnant or breast-feeding, or plans to become pregnant during the study.
2. Has received any investigational medicinal product (IMP) within 30 days or 5
half-lives (whichever is longer) prior to Day -8.
3. Known brain metastases, unless previously treated and well-controlled for at least 3
months (defined as clinically stable, no oedema, no steroids and stable in 2 scans at
least 4 weeks apart).
4. Gastrointestinal condition that could interfere with the swallowing or absorption of
study medication.
5. Part A: Has received prior systemic treatments for pancreatic cancer, except those
given in the adjuvant setting, and with recurrence more than 6 months after completion
of curative/adjuvant treatment.
6. Part B: Has received no previous radiotherapy, surgery, chemotherapy, or
investigational therapy for the treatment of metastatic disease. Prior treatment with
5-FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is
allowed, provided at least 6 months have elapsed since completion of the last dose and
no lingering toxicities are present. Participants having received cytotoxic doses of
gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for
this study.
7. History of malignancy other than in situ cancer or basal or squamous cell skin cancer
in the last 5 years.
8. Major surgery, other than diagnostic surgery (i.e., surgery done to obtain a biopsy
for diagnosis without removal of an organ), within 4 weeks prior to Day -8.
9. Known human immunodeficiency virus (HIV) and/or history of Hepatitis B or C infections
or known to be positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C
Antibody.
10. Known history of myocardial infarction, coronary stenting, stroke, or cerebrovascular
accident within 6 months prior to the first dose of study drug.
11. Focal palliative radiotherapy (e.g., to a bony metastasis) within the 14 days prior to
Run-in, or more extensive radiotherapy within 28 days prior to Run-in.
12. History of chronic leukemias (e.g., chronic lymphocytic leukemia).
13. History of interstitial lung disease, history of slowly progressive dyspnoea and
unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary
hypersensitivity pneumonitis or multiple allergies.
14. History of connective tissue disorders (e.g., lupus, scleroderma, arteritis nodosa).
15. Clinical signs of active infection and/or a temperature of > 38.0°C at the time of
Screening or Baseline. Study entry may be deferred at the discretion of the Principal
Investigator (PI).
16. Currently using warfarin.
17. Administration of a live virus vaccine in the 4 weeks prior to Day -8 or plans to
receive a live virus vaccine during the study.
18. Clinically significant allergies to AMP945, nab-paclitaxel or gemcitabine (or any of
their excipients), including hypersensitivity reactions to human albumin, that are not
likely to be well controlled with premedication or other supportive measures.
19. Exhibiting any of the conditions or events outlined in the Contraindications or
Special Warnings and Precautions sections of the nab-paclitaxel and/or gemcitabine
package inserts.
20. Peripheral neuropathy > Grade 1.
21. Corrected QT interval using Fridericia's correction (QTcF) > 460 ms for males and >480
ms for females.
22. Any clinically relevant medical, social, or psychiatric conditions, or any finding
during Screening, which in the Investigator's opinion may put the participant at
unacceptable risk or interfere with the study objectives.
23. Prior treatment with AMP945.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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
Single group
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Other design features
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Phase
Phase 1/Phase 2
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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
31/05/2022
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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
1/05/2025
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Actual
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Sample size
Target
62
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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GenesisCare - St Leonards
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Recruitment hospital [2]
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Westmead Hospital - Westmead
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Recruitment hospital [3]
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Gallipolli Medical Research Foundation - Greenslopes
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Recruitment hospital [4]
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Epworth Healthcare - Box Hill
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Recruitment hospital [5]
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Monash Health - Clayton
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Recruitment hospital [6]
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Epworth Healthcare - Richmond
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Recruitment hospital [7]
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Western Health - St Albans
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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4120 - Greenslopes
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Recruitment postcode(s) [4]
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3128 - Box Hill
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Recruitment postcode(s) [5]
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3168 - Clayton
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Recruitment postcode(s) [6]
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3121 - Richmond
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Recruitment postcode(s) [7]
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3021 - St Albans
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Recruitment outside Australia
Country [1]
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Korea, Republic of
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State/province [1]
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Gyeonggi-do
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Country [2]
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Korea, Republic of
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State/province [2]
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Seoul
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amplia Therapeutics Limited
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a multicentre, open label, two-part study to determine whether the focal adhesion
kinase (FAK) inhibitor AMP945, when given prior to dosing with gemcitabine and
nab-paclitaxel, improves response to therapy in first-line patients with unresectable or
metastatic pancreatic cancer.
Part A is a phase 1b dose-escalation design that will enrol at least 3 participants in each
of 4 dose-level cohorts, to determine the RP2D of AMP945 to be explored in Part B.
Part B will determine the efficacy of the AMP945 regimen at the RP2D, and will be run as a
Simon Two-stage design; Stage 1 will enrol 26 participants. If =5 of the 26 participants show
an objective response, then recruitment will be paused and a detailed analysis of futility
will be performed. If the study is deemed futile, recruitment will cease. If the study is
determined to be not futile or >5 of the 26 participants show an objective response,
recruitment will continue, and an additional 24 participants will be enrolled in Stage 2.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05355298
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Trial Information
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Address
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Phone
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+61 3 9123 1140
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Fax
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Email
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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/ct2/show/NCT05355298
Download to PDF