Phase Ib Study AZD1775 in Combination with Carboplatin and Paclitaxel in Adult Asian Patients with Solid Tumours - None
Study identifier:D6011C00003
ClinicalTrials.gov identifier:NCT02341456
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official 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
Medical condition
Advanced Solid Tumours
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD1775, Paclitaxel, carboplatin
Sex
All
Actual Enrollment
19
Study type
Interventional
Age
18 Years - 100 Years
Date
Study Start Date: 16 Jan 2015
Primary Completion Date: 23 Aug 2017
Study Completion Date: 09 Jul 2018
Study design
Allocation: Non-randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Feb 2020 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| 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. | Drug: 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. Other Name: MK1775 |
| 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. | Drug: Paclitaxel Paclitaxel is a mitotic inhibitor used in cancer chemotherapy ; it and docetaxel represent the taxane family of drugs. |
| 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. | Drug: 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.). |
Contacts
Investigators
Principal Investigator
Dr. Paul De Souza
Liverpool Hospital, New South Wales
