Samotolisib for Cancer

Recruiting in Palo Alto (17 mi)

+132 other locations

Overseen ByTheodore W Laetsch

Age: < 65

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

Trial Summary

What is the purpose of this trial?This phase II Pediatric MATCH trial studies how well samotolisib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with TSC or PI3K/MTOR mutations that have spread to other places in the body (metastatic) and have come back (recurrent) or do not respond to treatment (refractory). Samotolisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

This trial is for children and young adults with advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have specific genetic mutations (TSC or PI3K/MTOR), are resistant to treatment, or have returned after treatment. Participants must meet certain health criteria like normal organ function and recovery from previous therapies. Pregnant individuals, those on certain medications like corticosteroids, or with uncontrolled infections cannot join.

Inclusion Criteria

My body surface area meets the required minimum for my treatment dose level.

My blood tests show enough neutrophils and platelets, and I haven't needed a platelet transfusion in the last week.

I have waited the required time after my last radiation therapy before joining this trial.

My kidney function is normal or near normal.

I have not been treated with LY3023414 or drugs targeting the PI3K/MTOR pathway.

Participant Groups

The study tests samotolisib's effectiveness in halting cancer cell growth by blocking enzymes needed for their proliferation. It's a phase II trial focusing on patients whose cancer has spread and doesn't respond to standard treatments. The trial includes imaging procedures such as CT scans and MRIs to monitor the disease.

1Treatment groups

Experimental Treatment

Group I: Treatment (samotolisib)Experimental Treatment6 Interventions

Patients receive samotolisib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unexpected toxicity. Patients undergo an x-ray, CT, MRI, FDG-PET, and blood sample collection on study.