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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 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.

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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.

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

FieldValue
Enrollment Target 63 participants
Start Date 2012-04
Est. Completion 2018-03
Phase Phase 2

Sponsor

Massachusetts General Hospital

2,032 total trials

What the Registry Record Tells You About NCT01652079

The ClinicalTrials.gov registry entry for NCT01652079 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (91% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.