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NCT01652079 · ClinicalTrials.gov registry record · Phase 2
CRLX101 in Combination With Bevacizumab for Recurrent Ovarian/Tubal/Peritoneal Cancer
A Phase 2 study of Ovarian Cancer and Fallopian Tube Cancer, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
- 4
- Study locations
NCT01652079: Completed Phase 2 study of Ovarian Cancer and Fallopian Tube Cancer, sponsored by Massachusetts General Hospital.
NCT01652079 is a Phase 2 study of Ovarian Cancer and Fallopian Tube Cancer that has completed, run by Massachusetts General Hospital. The registered enrollment target is 63 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (91% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01652079, a Phase 2 study of Ovarian Cancer and Fallopian Tube Cancer, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
- 4
- Study locations
Study Summary
This research study is a Phase II clinical trial. In addition to studying safety, Phase II clinical trials test if the investigational drug is effective and whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA (the U.S. Food and Drug Administration) has not yet approved CRLX101 for your type of cancer. Camptothecin is a chemical extracted from plants that is the basis for the standard FDA-approved chemotherapy drugs irinotecan and topotecan. Camptothecin works by interfering with the way cells divide and multiply. The investigational drug CRLX101 is a formulation of camptothecin and a large molecule (nanoparticle)that appears to allow more of the camptothecin to get into tumors and stay in tumors. The persistence of the CRLX101 in the tumor may increase the probability that the tumor cells will be damaged. CRLX101 has been well tolerated in the laboratory and in participants with different kinds of cancer. Bevacizumab (Avastin) is a VEGF inhibitor which has activity in many kinds of cancer. Bevacizumab has been successfully combined with many chemotherapy partners. It has been hypothesized that the combination of bevacizumab with CRLX101 might have unique clinical activity in combination in the treatment of this disease due to the simultaneous inhibition of distinct steps along the HIF → (CAIX) → VEGF → VEGFR2 pathway. Specifically, it is hypothesized that CRLX101-mediated inhibition of HIF-1α carries with it the potential to interrupt hypoxia and HIF-1α-associated resistance to VEGFR inhibitors. It is hoped that this combination will work to treat your type of cancer.
Primary Outcome
Progression free survival at 6 months (PFS6) using RECIST 1.1
Conditions Studied
Interventions
- DRUG CRLX101
Study Locations (4)
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- Brigham and Women's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2012-04 |
| Est. Completion | 2018-03 |
| Phase | Phase 2 |
What the finished NCT01652079 record still lists
NCT01652079 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (91% lower).
The record links to 3 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 1 intervention - of which CRLX101 is the first listed.
NCT01652079 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01652079 about?
NCT01652079 is a clinical study titled "CRLX101 in Combination With Bevacizumab for Recurrent Ovarian/Tubal/Peritoneal Cancer". This research study is a Phase II clinical trial. In addition to studying safety, Phase II clinical trials test if the investigational drug is effective and whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors ar...
What is the current status of trial NCT01652079?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2012-04. Estimated completion is 2018-03.
What conditions does trial NCT01652079 study?
This clinical trial studies the following conditions: Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer.
What interventions are being tested in trial NCT01652079?
The interventions under investigation include: CRLX101 (DRUG).
Who is sponsoring clinical trial NCT01652079?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01652079 being conducted?
This trial has 4 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ovarian Cancer
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 NCT01652079's enrollment target sits among peer trials
63 189th of 322 higher than 133 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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