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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)

Must not have

Patients who previously received gemcitabine for the treatment of recurrent disease

Patients who are receiving any other investigational agents

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

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.

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.

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

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You should be able to perform everyday activities without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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You have received gemcitabine before for treating the same disease.

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You are currently taking any other experimental medications.

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If you have HIV and are taking multiple medications to treat it, you cannot participate.

Timeline

Screening ~ 3 weeks3 visits

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival

Secondary study objectives

Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment

Objective Response

Overall Survival

+3 more

Other study objectives

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

Adavosertib

2015

Completed Phase 2

~570

Gemcitabine Hydrochloride

2005

Completed Phase 3

~5420