CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Guadecitabine +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02901899
NCT02901899Phase 2Completed

An Open Label Phase II Trial of Guadecitabine and Pembrolizumab in Platinum Resistant Recurrent Ovarian Cancer

Northwestern University·interventional·Posted Sep 15, 2016·Updated Feb 20, 2024

In Brief

A Phase 2 clinical trial evaluating Guadecitabine, Laboratory Biomarker Analysis, and 1 other intervention for Recurrent Fallopian Tube Carcinoma and 2 related conditions. Completed, enrolled 45 participants across 3 sites.

Detailed Summary

The purpose of this study is to look at how patients respond to treatment with guadecitabine and pembrolizumab. The researchers will also be looking at the amount of time it takes for cancer to get worse when participants take the study drugs. All participants will be treated with guadecitabine and pembrolizumab. Guadecitabine interferes with the cancer cells' DNA and can increase the production of certain proteins, making cancer cells more recognizable by the immune system. Pembrolizumab helps your immune system to kill cancer cells. Thus the combination of guadecitabine and pembrolizumab may increase the ability of the immune system to eliminate cancer cells. Researchers want to find out whether the combination of guadecitabine and pembrolizumab is effective in treating ovarian cancer that has not responded to traditional chemotherapy. Participants will keep receiving treatment until their cancer gets worse, they have side effects, or they decide they don't want to receive the treatment anymore. After stopping treatment, the study doctor will watch participants for side effects and follow their condition every 6-12 weeks. The study aims to keep track of participants' medical conditions for the rest of their lives. This helps us look at the long-term effects of the study drugs.

Study Details

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 15, 2016
Enrollment StartNov 11, 2016
Primary CompletionApr 1, 2020
Study CompletionMar 31, 2023
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 9.8 years ago

Interventions

Guadecitabinedrug

Given SC

Laboratory Biomarker Analysisother

Correlative studies

Pembrolizumabbiological

Given IV