CRLX101 in Combination With Bevacizumab for Recurrent Ovarian/Tubal/Peritoneal Cancer

NCT01652079 | Completed Phase 2 DMC

• 1 other identifier: 11-485
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Keywords

Epithelial; Primary

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Progression free survival at 6 months (PFS6) using RECIST 1.1

  6 months

Secondary Outcomes (3)

• Response Rate

  2 years

• Assessment of Toxicity

  2 years

• Analysis of biopsies

  2 years

Study Arms (1)

Treatment Arm

EXPERIMENTAL

CRLX101

Drug: CRLX101

Interventions

CRLX101 DRUG

q 14 days

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed epithelial ovarian, tubal or primary peritoneal cancer
• Measurable disease
• May have received up to 2 prior cytotoxic chemotherapy
• Life expectancy of greater than 3 months

You may not qualify if:

• Pregnant or breastfeeding
• Prior camptothecin, prior VEFG inhibitors
• Gross hematuria
• Chemotherapy or radiotherapy within 4 weeks of study entry
• uncontrolled HTN
• Receiving other study agents
• History of allergic reaction to compounds of similar chemical or biologic composition to topotecan or irinotecan
• Known brain metastases
• History of a different malignancy within the previous 2 years
• Intercurrent illness
• HIV positive on combination antiretroviral therapy

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

IT-101

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Study Officials

• Richard Penson, MD, MRCP

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2012
• First Posted: July 27, 2012
• Study Start: April 1, 2012
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: July 2, 2018

Record last verified: 2018-06

Locations

US (4)