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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/NCT02341456
Registration number
NCT02341456
Ethics application status
Date submitted
9/01/2015
Date registered
19/01/2015
Date last updated
25/03/2019
Titles & IDs
Public title
Phase Ib Study AZD1775 in Combination With Carboplatin and Paclitaxel in Adult Asian Patients With Solid Tumours
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Scientific title
A Phase Ib, Dose Finding Study Evaluating AZD1775 in Monotherapy, in Combination With Carboplatin and Paclitaxel, and in Combination With Only Carboplatin in Adult Asian Patients With Advanced Solid Tumours
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Secondary ID [1]
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D6011C00003
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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:
Advanced Solid Tumours
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AZD1775
Treatment: Drugs - Paclitaxel
Treatment: Drugs - carboplatin
Experimental: AZD1775 - AZD1775 will be administered orally as a single dose on Day 1 Cycle 0. Following a 5±2 days washout period, AZD1775 (5 doses BID over 2.5 days) will be taken in combination with paclitaxel and carboplatin in each 21-day cycle for 6 cycles. Following 6 cycles of combination treatment, patients may continue on AZD1775 monotherapy (5 doses BID Day 1 to Day 2.5 in each 21-day cycle) at the investigator's discretion.
Experimental: Paclitaxel - Commercially available paclitaxel will be administered at a dosage of 175 mg/m2 as a 3-hour IV infusion on Cycle Day 1 of a 21-day cycle for 6 cycles.
Experimental: Carboplatin - Following the paclitaxel infusion, carboplatin will be administered at a dose of AUC 5 as an IV infusion on Cycle Day 1 of a 21-day cycle for 6 cycles. According to the Cancer Therapy Evaluation Program Information Letter Regarding the AUC Based Dosing of Carboplatin, the maximum carboplatin dose should not exceed the target AUC (mg*min/mL)*150 mL/min, but it may be less (Ivy et al 2010). For this study, the maximum dose of carboplatin cannot exceed a total dose of 750 mg.
Treatment: Drugs: AZD1775
AZD1775 is a highly selective, adenosine-triphosphate (ATP) competitive, small-molecule inhibitor of the WEE1 kinase that sensitizes tumour cells to cytotoxic agents and is being developed for the treatment of advanced solid tumours and p53 pathway deficient malignancies. Gemcitabine is a nucleoside analog used as chemotherapy.
Treatment: Drugs: Paclitaxel
Paclitaxel is a mitotic inhibitor used in cancer chemotherapy ; it and docetaxel represent the taxane family of drugs.
Treatment: Drugs: carboplatin
Carboplatin is a chemotherapy drug used against some forms of cancer (mainly ovarian carcinoma, lung, head and neck cancers as well as endometrial, esophageal, bladder, breast and cervical; central nervous system or germ cell tumors; osteogenic sarcoma, and as preparation for a stem cell or bone marrow transplant.).
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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 Patients With Treatment-Emergent Adverse Events
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Assessment method [1]
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The number of patients with treatment-emergent adverse events was analyzed on the safety analysis set which was comprised of all patients who received at least one dose of the investigational drug.
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Timepoint [1]
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Up to 21 days (1 Cycle)
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Primary outcome [2]
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Number of Treatment-Emergent Adverse Events (TEAE)
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Assessment method [2]
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The number of treatment-emergent adverse events was counted in the safety analysis set which was comprised of all patients who received at least one dose of the investigational drug.
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Timepoint [2]
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Up to 21 days (1 Cycle)
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Primary outcome [3]
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Number of Patients With Treatment-Emergent Adverse Events During AZD1775 Monotherapy Cycle by System Organ Class and Preferred Term
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Assessment method [3]
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The number of patients with TEAEs during AZD1775 Monotherapy Cycle was analyzed in the safety analysis set which was comprised of all patients who received at least one dose of the investigational drug.
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Timepoint [3]
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Up to 1 week
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Primary outcome [4]
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Number of Patients With Clinically Important Changes in Haematology and Coagulation TEAEs by System Organ Class and Preferred Term
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Assessment method [4]
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The number of patients with clinically important changes in haematology and coagulation TEAEs was analyzed in the safety analysis set which was comprised of all patients who received at least one dose of the investigational drug.
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Timepoint [4]
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Up to 21 days (1 Cycle)
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Primary outcome [5]
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Number of Patients With Clinically Important Abnormalities in Clinical Chemistry by Preferred Term
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Assessment method [5]
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The number of patients with clinically important changes in clinical chemistry TEAEs was analyzed in the safety analysis set which was comprised of all patients who received at least one dose of the investigational drug.
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Timepoint [5]
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Up to 21 days (1 Cycle)
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Primary outcome [6]
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Number of Patients With Clinically Important Abnormalities in Vital Signs by Preferred Term
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Assessment method [6]
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The number of patients with clinically important changes in vital sign TEAEs was analyzed in the safety analysis set which was comprised of all patients who received at least one dose of the investigational drug.
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Timepoint [6]
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Up to 21 days (1 Cycle)
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Secondary outcome [1]
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Best Overall Response
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Assessment method [1]
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The number of subjects with best overall response in CR, PR, NE, SD, PD subcategory. Best overall response is calculated based on the overall visit responses from each RECIST assessment.
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Timepoint [1]
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Up to 18 months
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Secondary outcome [2]
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Number of Patients With an Objective Response
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Assessment method [2]
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Objective response is defined as either a complete response or a partial response.
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Timepoint [2]
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Up to 18 months
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Secondary outcome [3]
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Percentage of Patients With an Objective Response
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Assessment method [3]
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Objective response is defined as either a complete response or a partial response.
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Timepoint [3]
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Up to 18 months
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Secondary outcome [4]
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Number of Patients With Clinical Benefit
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Assessment method [4]
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Clinical benefit is defined as achieving complete response, partial response, or stable disease.
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Timepoint [4]
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Up to 18 months
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Secondary outcome [5]
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Percentage of Patients With Clinical Benefit
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Assessment method [5]
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Clinical benefit is defined as achieving complete response, partial response, or stable disease.
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Timepoint [5]
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Up to 18 months
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Secondary outcome [6]
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Duration of Response
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Assessment method [6]
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The duration of response is defined as the time in weeks from the date of first documented overall response occurrence of CR or PR, (whichever was recorded first) to the earliest date that progressive disease/death was documented. If progression or death has not been documented, a patient's DoR was censored at the date of last tumour assessment.
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Timepoint [6]
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Up to 18 months
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Secondary outcome [7]
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Peak Plasma Concentration (Cmax) of AZD1775 Following Single Dose Administration of AZD1775 Monotherapy
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Assessment method [7]
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Timepoint [7]
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PK Samples collected in all treatment groups on Cycle 0 Day 1, Cycle 1 Day 1, and Cycle 1 Day 3 before the first (morning) dose of AZD1775 (predose) and at 1, 2, 4, 6, and 8 hours postdose
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Secondary outcome [8]
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Time to Maximum Plasma Concentration (Tmax) of AZD1775 Following Single Dose Administration of AZD1775 Monotherapy
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Assessment method [8]
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Timepoint [8]
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PK Samples will be collected in all treatment groups on Cycle 0 Day 1, Cycle 1 Day 1, and Cycle 1 Day 3 before the first (morning) dose of AZD1775 (predose) and at 1, 2, 4, 6, and 8 hours postdose
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Secondary outcome [9]
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Area Under the Plasma Concentration-time Curve From Zero to the Time of the Last Measurable Concentration (AUC0-t) Following Single Dose Administration of AZD1775 Monotherapy
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Assessment method [9]
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Timepoint [9]
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PK Samples will be collected in all treatment groups on Cycle 0 Day 1, Cycle 1 Day 1, and Cycle 1 Day 3 before the first (morning) dose of AZD1775 (predose) and at 1, 2, 4, 6, and 8 hours postdose
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Secondary outcome [10]
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Plasma Concentration of AZD1775 8 Hours After Single Dose Administration (C8h) of AZD1775 Monotherapy
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Assessment method [10]
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Timepoint [10]
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PK Samples will be collected in all treatment groups on Cycle 0 Day 1, Cycle 1 Day 1, and Cycle 1 Day 3 before the first (morning) dose of AZD1775 (predose) and at 1, 2, 4, 6, and 8 hours postdose
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Secondary outcome [11]
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Peak Plasma Concentration (Cmax) of AZD1775 Following Oral Dose of AZD1775 in Combination With IV Infusion of Paclitaxel and Carboplatin (Cohorts 1 and 2) or Carboplatin Alone (Cohort 1a)
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Assessment method [11]
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Timepoint [11]
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AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion
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Secondary outcome [12]
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Time to Maximum Plasma Concentration (Tmax) of AZD1775 Following Single Dose of AZD1775 in Combination With IV Paclitaxel and Carboplatin (Cohorts 1 and 2) or Carboplatin Alone (Cohort 1a)
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Assessment method [12]
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0
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Timepoint [12]
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AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion
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Secondary outcome [13]
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Area Under the Plasma Concentration-time Curve From Zero to the Time of the Last Measurable Concentration (AUC0-t) Following Single Dose of AZD1775 in Combination With IV Paclitaxel and Carboplatin (Cohorts 1 and 2) or Carboplatin Alone (Cohort 1a)
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Assessment method [13]
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0
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Timepoint [13]
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AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion
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Secondary outcome [14]
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Plasma Concentration of AZD1775 8 Hours After Single Dose Administration (C8h) of AZD1775 in Combination With IV Paclitaxel and Carboplatin (Cohorts 1 and 2) or Carboplatin Alone (Cohort 1a)
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Assessment method [14]
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0
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Timepoint [14]
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AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion
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Secondary outcome [15]
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Peak Plasma Concentration (Cmax) of AZD1775 at Steady State When Given in Combination With IV Infusion of Paclitaxel and Carboplatin (Cohorts 1 and 2) or Carboplatin Alone (Cohort 1a)
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Assessment method [15]
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0
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Timepoint [15]
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AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion
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Secondary outcome [16]
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Time to Maximum Plasma Concentration (Tmax) of AZD1775 at Steady State When Given in Combination With IV Paclitaxel and Carboplatin (Cohorts 1 and 2) or Carboplatin Alone (Cohort 1a)
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Assessment method [16]
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0
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Timepoint [16]
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AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion
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Secondary outcome [17]
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Area Under the Plasma Concentration-time Curve From Zero to the Time of the Last Measurable Concentration (AUC0-t) at Steady State for AZD1775 in Combination With IV Paclitaxel and Carboplatin (Cohorts 1 and 2) or Carboplatin Alone (Cohort 1a)
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Assessment method [17]
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0
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Timepoint [17]
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AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion
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Secondary outcome [18]
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Plasma Concentration of AZD1775 8 Hours After Administration (C8h) at Steady State in Combination With IV Paclitaxel and Carboplatin (Cohorts 1 and 2) or Carboplatin Alone (Cohort 1a)
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Assessment method [18]
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0
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Timepoint [18]
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AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion
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Secondary outcome [19]
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Peak Plasma Concentration (Cmax) of Paclitaxel Following Single IV Infusion in Combination With Single Dose Oral AZD1775 and IV Carboplatin
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Assessment method [19]
0
0
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Timepoint [19]
0
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AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion
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Secondary outcome [20]
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Area Under the Plasma Concentration-time Curve (AUC0-t) of Paclitaxel Following Single IV Infusion in Combination With Single Dose Oral AZD1775 and IV Carboplatin
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Assessment method [20]
0
0
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Timepoint [20]
0
0
AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion
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Secondary outcome [21]
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0
Plasma Concentration of Paclitaxel at the End of Infusion (Ceoi) When Given Combination With Oral AZD1775 and IV Carboplatin.
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Assessment method [21]
0
0
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Timepoint [21]
0
0
AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion
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Secondary outcome [22]
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0
Time to Maximum Plasma Concentration (Tmax) of IV Paclitaxel When Given in Combination With Oral AZD1775 and IV Carboplatin
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Assessment method [22]
0
0
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Timepoint [22]
0
0
AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion
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Secondary outcome [23]
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0
Time to Last Detectable Concentration (Tlast) of Paclitaxel When Given in Combination With Oral AZD1775 and IV Carboplatin
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Assessment method [23]
0
0
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Timepoint [23]
0
0
AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion
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Secondary outcome [24]
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Peak Plasma Concentration (Cmax) of Platinum Following Single IV Infusion of Carboplatin Over 1 Hour in Combination With Single Oral Dose AZD1775 Alone (Cohort 1a) or With IV Paclitaxel (Cohorts 1 and 2)
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Assessment method [24]
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0
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Timepoint [24]
0
0
AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion
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Secondary outcome [25]
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0
Area Under Plasma Concentration-time Curve From 0 to Last Measurable Conc. (AUC0-t) of Platinum Following Single IV Infusion of Carboplatin Over 1 Hour in Combination With Single Oral Dose AZD1775 Alone (Cohort 1a) or With IV Paclitaxel (Cohorts 1 & 2)
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Assessment method [25]
0
0
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Timepoint [25]
0
0
AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion
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Secondary outcome [26]
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0
Plasma Concentration of Platinum at the End of Infusion (Ceoi) When Given as a 1 Hour Infusion in Combination With Oral AZD1775 and IV Paclitaxel.
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Assessment method [26]
0
0
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Timepoint [26]
0
0
AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion
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Secondary outcome [27]
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0
Time to Peak Plasma Concentration of Platinum (Tmax) When Given as a 1 Hour Infusion in Combination With Oral AZD1775 and IV Paclitaxel.
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Assessment method [27]
0
0
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Timepoint [27]
0
0
AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion
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Secondary outcome [28]
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0
Time to Last Detectable Concentration of Platinum (Tlast) When Given as a 1 Hour Infusion in Combination With Oral AZD1775 and IV Paclitaxel.
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Assessment method [28]
0
0
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Timepoint [28]
0
0
AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion
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Secondary outcome [29]
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0
Peak Plasma Concentration (Cmax) of Platinum Following Single IV Infusion of Carboplatin Over 2 Hours in Combination With Single Oral Dose AZD1775 Alone (Cohort 1a) or With IV Paclitaxel (Cohorts 1 and 2)
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Assessment method [29]
0
0
Query!
Timepoint [29]
0
0
AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion
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Secondary outcome [30]
0
0
Area Under Plasma Concentration-time Curve From 0 to Last Measurable Conc. (AUC0-t) of Platinum Following Single IV Infusion of Carboplatin Over 2 Hours in Combination With Single Oral Dose AZD1775 Alone (Cohort 1a) or With IV Paclitaxel (Cohorts 1 & 2)
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Assessment method [30]
0
0
Query!
Timepoint [30]
0
0
AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion
Query!
Secondary outcome [31]
0
0
Plasma Concentration of Platinum at the End of Infusion (Ceoi) When Given as a 2 Hour Infusion in Combination With Oral AZD1775 and IV Paclitaxel.
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Assessment method [31]
0
0
Query!
Timepoint [31]
0
0
AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion
Query!
Secondary outcome [32]
0
0
Time to Peak Plasma Concentration of Platinum (Tmax) When Given as a 2 Hour Infusion in Combination With Oral AZD1775 and IV Paclitaxel.
Query!
Assessment method [32]
0
0
Query!
Timepoint [32]
0
0
AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion
Query!
Secondary outcome [33]
0
0
Time to Last Detectable Concentration of Platinum (Tlast) When Given as a 2 Hour Infusion in Combination With Oral AZD1775 and IV Paclitaxel.
Query!
Assessment method [33]
0
0
Query!
Timepoint [33]
0
0
AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion
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Eligibility
Key inclusion criteria
- Histological or cytological confirmation of a locally advanced or metastatic solid
tumour, excluding lymphoma, that failed to respond to standard therapy, progressed
despite standard therapy, or for which standard therapy does not exist.
- At least 1 measureable lesion that can be accurately assessed at baseline by
computerised tomography (CT) or magnetic resonance imaging (MRI) for solid tumours
assessed using RECIST v1.1.
- World Health Organisation performance status 0 to 1 with no deterioration over the
previous 2 weeks and a minimum life expectancy of =12 weeks.
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Minimum age
18
Years
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Maximum age
100
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
- Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a
previous treatment regimen or clinical study within 14 days (if investigational agent
does not have well characterised PK profile) or 5 × half-lives of the first dose of
study treatment
- Patient has had prescription or non-prescription drugs or other products (ie,
grapefruit juice) known to be sensitive to CYP3A4 substrates or CYP3A4 substrates with
a narrow therapeutic index, or to be moderate to strong inhibitors or inducers of
CYP3A4, which cannot be discontinued 2 weeks before Day 1 of dosing and withheld
throughout the study until 2 weeks after the last dose of study drug.
Co-administration of aprepitant during this study is prohibited.
- AZD1775 is an inhibitor of breast cancer resistance protein (BCRP). The use of statins
including Atorvastatin which are substrates for BCRP are therefore prohibited and
patients should be moved on to non-BCRP alternatives.
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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
Parallel
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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
Completed
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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
16/01/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
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Actual
9/07/2018
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Sample size
Target
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Accrual to date
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Final
19
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Liverpool
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Recruitment hospital [2]
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Research Site - Melbourne
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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Japan
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State/province [1]
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Kashiwa
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Country [2]
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Japan
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State/province [2]
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Sapporo-shi
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Country [3]
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Korea, Republic of
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State/province [3]
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Seoul
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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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 phase Ib, open-label, multicentre study of AZD1775 administered orally in
monotherapy and in combination with carboplatin and paclitaxel to Asian patients with
advanced solid tumours.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02341456
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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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Dr. Paul De Souza, MD
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Address
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Liverpool Hospital, New South Wales
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02341456
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