MedTrace Logo

Adavosertib Plus Chemotherapy in Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT02272790 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2023-10-03

Study results available
· View outcomes & findings →

Summary

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

Conditions

  • Ovarian, Fallopian Tube, Peritoneal Cancer, P53 Mutation

Interventions

DRUG

Adavosertib

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

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.

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.

DRUG

Gemcitabine

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

DRUG

PLD

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

Sponsors & Collaborators

Principal Investigators

  • Kathleen Moore, MD · Stephenson Cancer Center, University of Oklahoma Health Sciences Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-30
Primary Completion
2018-12-13
Completion
2023-03-08
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02272790 on ClinicalTrials.gov