Back to Ovarian Cancer
This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT01357161

NCT01357161
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with ovarian, fallopian tube, or primary peritoneal cancer (confirmed by a tissue sample), and it is not a low-grade or borderline type.
  • Your cancer has come back or gotten worse after receiving chemotherapy that included paclitaxel and a platinum-based drug.
  • Your cancer returned or progressed 6 months or more after finishing your most recent platinum-based chemotherapy (known as "platinum-sensitive" disease).
  • Your cancer can be measured on scans or imaging.
  • A tumour tissue sample is available from your diagnosis or treatment.
  • You are generally well enough to carry out light activity and care for yourself (confirm with trial site).
  • Your heart, liver, kidneys, and other organs are working well enough (confirm with trial site).

Who may not be able to join:

  • You are pregnant or planning to become pregnant during the study.
  • You have taken part in another clinical trial or used an experimental drug or device within the past 28 days.
  • Your cancer has spread to the brain or spinal fluid, or you have a primary brain tumour.
  • You have a known allergy or medical reason why you cannot take paclitaxel, carboplatin, or adavosertib, or related substances used in their preparation.
  • You take certain medications that affect how the body processes a specific liver enzyme (CYP3A4) — confirm with the trial site which medications apply.
  • You have nerve damage (such as numbness or tingling) of a moderate level or worse from previous treatment.
  • You have a known mental health condition or substance use disorder.
  • You regularly use illegal drugs, or have had a problem with drugs or alcohol within the past year.
  • You are HIV positive.
  • You have active Hepatitis B or Hepatitis C.
  • You have a build-up of fluid in your abdomen or around your lungs that is causing symptoms.
  • Your personal or family medical history suggests a rare inherited condition called Li-Fraumeni Syndrome (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Merck Sharp & Dohme LLC
Registry
clinicaltrials_gov
Start date
26 July 2011
Est. completion
8 August 2016

Primary endpoints

Part 2: Median Progression-free Survival (PFS) in Weeks Based on Enhanced Response Evaluation Criteria In Solid Tumors Version 1.1 (Enhanced RECIST 1.1) by Independent Radiology Review; Part 1: Number of Participants With a Dose Limiting Toxicity (DLT); Parts 1 and 2: Percentage of Participants That Experienced an Adverse Event (AE); Parts 1 and 2: Percentage of Participants That Discontinued Study Treatment Due to an AE

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov