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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: Active Phase 2 study of Recurrent Fallopian Tube Carcinoma and Ovarian Endometrioid Adenocarcinoma, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To evaluate the progression free survival (PFS) of subjects with recurrent platinum-resistant ovarian, fallopian tube or primary peritoneal cancer receiving gemcitabine in combination with AZD1775 compared to subjects receiving gemcitabine in combination with placebo. Progression is defined, using the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guideline, as at least a 20% increase in the sum of the diameters of target lesions or the appearance of one or more new lesions.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2014-07-21 |
| Est. Completion | 2027-03-06 |
| Phase | Phase 2 |
What the registry record for NCT02101775 still lists
NCT02101775 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 226-participant average among 35 other Recurrent Fallopian Tube Carcinoma trials with a reported enrollment target (45% lower).
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 lists 16 locations in 9 states (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.
Learn More About Clinical Trials
Similar trials for Recurrent Fallopian Tube Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02101775's enrollment target sits among peer trials
124 8th of 35 higher than 28 of 35 other Recurrent Fallopian Tube Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Fallopian Tube Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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