Adavosertib plus Chemotherapy in Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer - None
Study identifier:D6010C00004
ClinicalTrials.gov identifier:NCT02272790
EudraCT identifier:2015-000886-30
CTIS identifier:N/A
Study Complete
Official Title
A Multicentre Phase II Study of Adavosertib plus Chemotherapy in Patients with Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Medical condition
Ovarian, Fallopian Tube, Peritoneal Cancer, P53 mutation
Phase
Phase 2
Healthy volunteers
No
Study drug
Adavosertib, Paclitaxel, Carboplatin, Gemcitabine, PLD
Sex
Female
Actual Enrollment
95
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 30 Jan 2015
Primary Completion Date: 13 Dec 2018
Study Completion Date: 08 Mar 2023
Study design
Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2023 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm A (adavosertib + gemcitabine) Adavosertib (175 mg PO) will be taken on Days 1-2, 8-9, and 15-16. Gemcitabine 800 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle. | Drug: Adavosertib Adavosertib will be taken as oral capsules with water, approx. 2 hours before or 2 hours after food. Other Name: MK1775 Drug: Gemcitabine Gemcitabine 800 mg/m² will be administered IV on Days 1, 8, and 15 of each 28-Day cycle. |
| Experimental: Arm B (adavosertib + paclitaxel) Five doses of adavosertib (225 mg PO BID) will be taken in approximate 12 hour intervals over 2.5 days weekly (Days 1-3, 8-10, and 15-17). Weekly paclitaxel 80 mg/m² IV will be administered according to institutional standards on Day 1, 8, and 15 of each 28 day cycle. | Drug: Adavosertib Adavosertib will be taken as oral capsules with water, approx. 2 hours before or 2 hours after food. Other Name: MK1775 Drug: Paclitaxel Paclitaxel will be administered as a 1-hour IV infusion (± 10 minutes) at a dose of 80 mg/m2 according to institutional standards on Days 1, 8, and 15 of each 28 Day cycle. Patients should be pre-medicated with corticosteroids, diphenhydramine and/or H2 antagonists according to institutional standards. Other Name: Taxol |
| Experimental: Arm C/C2 (adavosertib + carboplatin) Arm C: Five doses of adavosertib (225 mg PO BID) will be taken in approximate 12 hour intervals over 2.5 days (Days 1-3). Carboplatin AUC 5 IV will be administered according to institutional standards on Day 1 of each 21-Day cycle. Arm C2: Five doses of adavosertib (225 mg PO BID) 2.5 days per dosing week (QW), on Weeks 1 (D1-3), 2 (D8-10) and 3 (D15-17), or on Weeks 1 (D1-3) and 2 (D8-10) ( 2 weeks on followed by 1 week off.) Carboplatin AUC 5 IV will be administered according to institutional standards on Day 1 of each 21 day cycle. | Drug: Adavosertib Adavosertib will be taken as oral capsules with water, approx. 2 hours before or 2 hours after food. Other Name: MK1775 Drug: Carboplatin Carboplatin, at a dose calculated to produce an AUC of 5 will be administered by intravenous infusion according to institutional standards on Day 1 of each 21 Day cycle. The carboplatin dose will be calculated using the Calvert Formula based on the patient’s glomerular filtration rate (GFR) which is estimated by using the creatinine clearance. Other Name: Paraplatin |
| Experimental: Arm D (adavosertib + PLD) Five doses of adavosertib (175 mg or 225 mg) will be taken in approximate 12 hour intervals over 2.5 days (Days 1, 2, and 3) of each 28-day cycle. PLD will administered IV on Day 1 of each cycle. | Drug: Adavosertib Adavosertib will be taken as oral capsules with water, approx. 2 hours before or 2 hours after food. Other Name: MK1775 Drug: PLD PLD (pegylated liposomal doxorubicin) 40 mg/m² IV will be given on Day 1 of each 28-Day cycle. |
Contacts
Investigators
Principal Investigator
Kathleen Moore
Stephenson Cancer Center, University of Oklahoma Health Sciences Center
