CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 95 enrolled
Drug / intervention
Adavosertib +4 moredrug
Likely dose
Paclitaxel 80 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02272790
NCT02272790Phase 2Completed
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A Multicentre Phase II Study of Adavosertib Plus Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

AstraZeneca·interventional·Posted Oct 23, 2014·Updated Oct 3, 2023

In Brief

A Phase 2 clinical trial evaluating Adavosertib, Paclitaxel, and 3 other interventions for Ovarian, Fallopian Tube, Peritoneal Cancer, P53 Mutation. Completed, enrolled 95 participants across 20 sites in 3 countries.

Detailed Summary

Adavosertib in combination with carboplatin, paclitaxel, gemcitabine, or PLD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian, Fallopian Tube, Peritoneal Cancer, P53 Mutation
CountriesCanada, Netherlands, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 23, 2014
Enrollment StartJan 30, 2015
Primary CompletionDec 13, 2018
Study CompletionMar 8, 2023
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 11.7 years ago

Interventions

Adavosertibdrug

Adavosertib will be taken as oral capsules with water, approx. 2 hours before or 2 hours after food.

Paclitaxeldrug

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.

Carboplatindrug

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.

Gemcitabinedrug

Gemcitabine 800 mg/m² will be administered IV on Days 1, 8, and 15 of each 28-Day cycle.

PLDdrug

PLD (pegylated liposomal doxorubicin) 40 mg/m² IV will be given on Day 1 of each 28-Day cycle.