Cediranib + Olaparib vs Bevacizumab for Recurrent Glioblastoma

Recruiting at28 trial locations

Overseen by Isabel Arrillaga-Romany

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial compares two treatments for patients with glioblastoma that has returned. One treatment uses pills that block enzymes needed for tumor growth. The other treatment uses an IV drug that helps the immune system fight cancer and prevents tumors from growing. The goal is to see which treatment works better at stopping the cancer from progressing.

Research Team

Isabel Arrillaga-Romany

Principal Investigator

Dana-Farber - Harvard Cancer Center LAO

Eligibility Criteria

This trial is for adults with recurrent glioblastoma who've had prior radiotherapy and temozolomide treatment. Eligible participants must have stable or decreasing corticosteroid doses, adequate organ function, no severe allergies to the drugs being tested, and not be pregnant or breastfeeding. They should agree to use contraception and have a life expectancy of at least 3 months.

Inclusion Criteria

Leukocytes >= 3,000/mcL

My GBM has recurred no more than twice.

It's been over 12 weeks since my last radiotherapy, or my cancer has grown outside the treated area if it's been less.

Exclusion Criteria

I have not had an abdominal abscess in the last 6 months.

I have never had pneumonitis.

Participants may not have a dependency on IV hydration or total parenteral nutrition (TPN)

Treatment Details

Interventions

• Bevacizumab (Monoclonal Antibodies)
• Cediranib Maleate (Angiogenesis Inhibitor)
• Olaparib (PARP Inhibitor)

Trial Overview The study compares cediranib maleate plus olaparib against bevacizumab in treating recurrent glioblastoma. Cediranib maleate and olaparib are thought to block enzymes needed for tumor growth, while bevacizumab is an immunotherapy that may inhibit cancer spread.

Participant Groups

Group I: Arm B (bevacizumab) Experimental Treatment 1 Intervention

Patients receive bevacizumab IV over 30-90 minutes every 2 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (olaparib, cediranib maleate) Experimental Treatment 3 Interventions

Patients receive olaparib PO BID and cediranib maleate PO once QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Bevacizumab is already approved in Japan, Canada for the following indications:

Approved in Japan as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in Canada as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School