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Anti-metabolites

Gemcitabine +/− MK-1775 for Ovarian Cancer

Phase 2
Waitlist Available
Led By Amit M Oza
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be able to tolerate oral medication and not have evidence of active bowel obstruction
Patients must have disease amenable to biopsy and must be willing to undergo a paired biopsy for correlative analyses (the first biopsy within 28 days prior to start of treatment and the second biopsy while on treatment)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment, every 6-8 weeks, until time of progression or death, whichever occurs first, up to 1 year follow-up
Awards & highlights

Study Summary

This trial is studying 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.

Who is the study for?
This trial is for patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer who are platinum-resistant or have platinum-refractory disease. They must have a life expectancy over 3 months, acceptable blood counts and organ function, and be able to tolerate oral medication without an active bowel obstruction. Women of childbearing potential must use contraception.Check my eligibility
What is being tested?
The study compares the effectiveness of gemcitabine hydrochloride alone versus combined with WEE1 inhibitor MK-1775 in treating certain cancers that have returned after treatment. The aim is to see if blocking WEE1 protein activity with MK-1775 enhances the impact of gemcitabine by preventing tumor cell repair.See study design
What are the potential side effects?
Potential side effects include damage to normal cells leading to low blood counts, increased risk of infection, fatigue, nausea, and possible allergic reactions. Specific side effects related to WEE1 inhibitor MK-1775 may also occur but are not detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You should be able to perform everyday activities without help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment, every 6-8 weeks, until time of progression or death, whichever occurs first, up to 1 year follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment, every 6-8 weeks, until time of progression or death, whichever occurs first, up to 1 year follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival
Secondary outcome measures
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Objective Response
Overall Survival
+3 more
Other outcome measures
Change in Levels of Circulating Deoxyribonucleic Acid TP53 Mutations by TAm-Seq
Changes in gH2AX in Skin and Tumor Tissue
Changes in pCDC2
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (WEE1 inhibitor MK-1775, gemcitabine hydrochloride)Experimental Treatment5 Interventions
Patients receive WEE1 inhibitor MK-1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (placebo, gemcitabine hydrochloride)Active Control5 Interventions
Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Adavosertib
2015
Completed Phase 2
~570

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,029 Total Patients Enrolled
15 Trials studying Ovarian Brenner Tumor
5,928 Patients Enrolled for Ovarian Brenner Tumor
Amit M OzaPrincipal InvestigatorUniversity Health Network-Princess Margaret Hospital
2 Previous Clinical Trials
76 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other scientific research has been completed with Gemcitabine Hydrochloride?

"478 clinical trials are currently underway to study Gemcitabine Hydrochloride. 137 of those trials have progressed to Phase 3, the final stage before FDA approval can be given. The majority of these studies are conducted in Woolloongabba, Queensland; however, there are 26328 locations running trials for this treatment globally."

Answered by AI

Is Gemcitabine Hydrochloride a danger to patients?

"There is data suggesting that Gemcitabine Hydrochloride is safe, but not yet effective. Consequently, it received a score of 2."

Answered by AI

How many sites are currently running this trial?

"There are 17 clinical trial sites currently looking for patients to enroll. These locations include Hamilton, South Pasadena, Rochester and 14 other cities. Keep in mind that if you choose to enroll, it may be more convenient to select a site closer to your home."

Answered by AI

Are recruitment efforts still underway for this research project?

"Unfortunately, this particular clinical trial is not admitting patients at the moment. The study was first created on July 21st, 2014 and updated on August 11th, 2022. However, there are 4158 trials for ovarian brenner tumor and 478 studies involving Gemcitabine Hydrochloride that are still looking for participants."

Answered by AI

What disease or condition is Gemcitabine Hydrochloride most often used as a treatment for?

"small cell lung cancer (sclc), head and neck carcinoma, and pancreatic adenocarcinoma locally advanced can all be effectively treated with Gemcitabine Hydrochloride."

Answered by AI

How many people can join this research project?

"Unfortunately, this particular study is not currently searching for new patients. Although, it is worth mentioning that the trial was last updated on 8/11/2022 and originally posted on 7/21/2014. If you are interested in other clinical trials, there are 4158 active studies recruiting patients with ovarian brenner tumor and 478 trials enrolling participants for Gemcitabine Hydrochloride treatment."

Answered by AI
Recent research and studies
The LancetJournal
Adavosertib Plus Gemcitabine for Platinum-resistant or Platinum-refractory Recurrent Ovarian Cancer: A Double-blind, Randomised, Placebo-controlled, Phase 2 Trial
Lheureux, Stephanie, Mihaela C Cristea, Jeffrey P Bruce, Swati Garg, Michael Cabanero, Gina Mantia-Smaldone, Alexander B Olawaiye, et al.. 2021. “Adavosertib Plus Gemcitabine for Platinum-resistant or Platinum-refractory Recurrent Ovarian Cancer: A Double-blind, Randomised, Placebo-controlled, Phase 2 Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(20)32554-x.
clinicaltrials.govStudy
Gemcitabine Hydrochloride With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
2014. "Gemcitabine Hydrochloride With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02101775.
All > Adenocarcinoma > Recurrent Ovarian Cancer
~12 spots leftby Apr 2025
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