Sapanisertib + Bevacizumab for Glioblastoma

Recruiting at2 trial locations

Overseen by Lakshmi Nayak

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of raptor/rictor-mammalian target of rapamycin (mTOR) (TORC1/2) inhibitor MLN0128 when given in combination with bevacizumab in treating patients with glioblastoma, a type of brain tumor, or a solid tumor that has spread and not responded to standard treatment. TORC1/2 inhibitor MLN0128 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the progression of tumors by blocking the growth of new blood vessels necessary for tumor growth.

Research Team

Lakshmi Nayak

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for adults with recurrent glioblastoma or advanced solid tumors that haven't responded to standard treatments. Participants must be able to swallow capsules, have no other concurrent cancers (except certain skin cancers), and use contraception if of child-bearing potential. They should not be on corticosteroids, pregnant, nursing, or have significant allergies to the drugs being tested.

Inclusion Criteria

Your blood and body chemistry need to be within certain limits.

I have a confirmed diagnosis of recurrent glioblastoma or an advanced cancer treatable with bevacizumab.

I have no other cancers except possibly treated skin cancer.

Exclusion Criteria

I have a stomach or intestine problem that affects how I absorb pills.

I haven't used specific growth factors recently.

I do not have uncontrolled high blood pressure, asthma, or diabetes.

Treatment Details

Interventions

• Bevacizumab (Monoclonal Antibodies)
• MLN0128 (TORC1/2 Inhibitor)

Trial Overview The trial is testing a combination of TORC1/2 inhibitor MLN0128 and monoclonal antibody Bevacizumab in patients with specific types of brain and solid tumors. It aims to find the safest dose while assessing how these drugs might block tumor growth by inhibiting enzymes needed for cell growth and blood vessel formation.

Participant Groups

Group I: Treatment (TORC1/2 inhibitor INK128, bevacizumab) Experimental Treatment 4 Interventions

Patients receive TORC1/2 inhibitor INK128 PO QD on days 1-28 and bevacizumab IV on days 1 and 15. Courses 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