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NCT02101775 · ClinicalTrials.gov registry record · Phase 2

Gemcitabine Hydrochloride With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

A Phase 2 study of Recurrent Fallopian Tube Carcinoma and Ovarian Endometrioid Adenocarcinoma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 2
Development phase
124
Enrollment target
16
Study locations

NCT02101775 is a Phase 2 study of Recurrent Fallopian Tube Carcinoma and Ovarian Endometrioid Adenocarcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 124 participants, below the 226-participant average among 35 other Recurrent Fallopian Tube Carcinoma trials with a reported enrollment target (45% lower). The trial reports 16 study locations across 9 states.

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The verdict

NCT02101775, a Phase 2 study of Recurrent Fallopian Tube Carcinoma and Ovarian Endometrioid Adenocarcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
124 participants
Enrollment target
16
Study locations

Study Summary

This randomized phase II clinical trial studies how well gemcitabine hydrochloride and WEE1 inhibitor MK-1775 work compared to gemcitabine hydrochloride alone in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of time. Gemcitabine hydrochloride may prevent tumor cells from multiplying by damaging their deoxyribonucleic acid (DNA, molecules that contain instructions for the proper development and functioning of cells), which in turn stops the tumor from growing. The protein WEE1 may help to repair the damaged tumor cells, so the tumor continues to grow. WEE1 inhibitor MK-1775 may block the WEE1 protein activity and may increase the effectiveness of gemcitabine hydrochloride by preventing the WEE1 protein from repairing damaged tumor cells without causing harm to normal cells. It is not yet known whether gemcitabine hydrochloride with or without WEE1 inhibitor MK-1775 may be an effective treatment for recurrent ovarian, primary peritoneal, or fallopian tube cancer.

Conditions Studied

Recurrent Fallopian Tube Carcinoma Ovarian Endometrioid Adenocarcinoma Ovarian Seromucinous Carcinoma Ovarian Brenner Tumor Ovarian Mucinous Cystadenocarcinoma Ovarian Clear Cell Cystadenocarcinoma Ovarian Serous Cystadenocarcinoma Ovarian Serous Surface Papillary Adenocarcinoma Ovarian Undifferentiated Carcinoma Ovarian Malignant Mixed Mesodermal (Mullerian) Tumor

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Gemcitabine Hydrochloride
  • OTHER Placebo Administration
  • OTHER Pharmacological Study
  • DRUG Adavosertib

Study Locations (16)

Ontario

  • London Regional Cancer Program - London
  • Ottawa Hospital and Cancer Center-General Campus - Ottawa
  • University Health Network Princess Margaret Cancer Center P2C - Toronto
  • University Health Network-Princess Margaret Hospital - Toronto

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • City of Hope South Pasadena - South Pasadena

Illinois

  • University of Chicago Comprehensive Cancer Center - Chicago
  • Decatur Memorial Hospital - Decatur

Pennsylvania

  • Fox Chase Cancer Center - Philadelphia
  • University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh

British Columbia

  • BCCA-Cancer Centre for the Southern Interior - Kelowna
  • BCCA-Vancouver Cancer Centre - Vancouver

Indiana

  • Indiana University/Melvin and Bren Simon Cancer Center - Indianapolis

Minnesota

  • Mayo Clinic in Rochester - Rochester

Quebec

  • CHUM - Centre Hospitalier de l'Universite de Montreal - Montreal

Trial Details

FieldValue
Enrollment Target 124 participants
Start Date 2014-07-21
Est. Completion 2027-03-06
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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What the Registry Record Tells You About NCT02101775

The ClinicalTrials.gov registry entry for NCT02101775 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 226-participant average among 35 other Recurrent Fallopian Tube Carcinoma trials with a reported enrollment target (45% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Recurrent Fallopian Tube Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT02101775 reports 16 study locations spanning 9 distinct geographic areas - top geographies include Ontario, California, Illinois.

Frequently Asked Questions

What is clinical trial NCT02101775 about?

NCT02101775 is a clinical study titled "Gemcitabine Hydrochloride With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer". This randomized phase II clinical trial studies how well gemcitabine hydrochloride and WEE1 inhibitor MK-1775 work compared to gemcitabine hydrochloride alone in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of time. Gemcitabine hydroc...

What is the current status of trial NCT02101775?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2014-07-21. Estimated completion is 2027-03-06.

What conditions does trial NCT02101775 study?

This clinical trial studies the following conditions: Recurrent Fallopian Tube Carcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Seromucinous Carcinoma, Ovarian Brenner Tumor, Ovarian Mucinous Cystadenocarcinoma.

What interventions are being tested in trial NCT02101775?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Gemcitabine Hydrochloride (DRUG), Placebo Administration (OTHER), Pharmacological Study (OTHER), Adavosertib (DRUG).

Who is sponsoring clinical trial NCT02101775?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02101775 being conducted?

This trial has 16 study locations across California, Illinois, Indiana, Minnesota, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.