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PI3K/mTOR inhibitor

Samotolisib for Cancer

Phase 2

Waitlist Available

Led By Theodore W Laetsch

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients accruing to dose level 1 must have a body surface area >= 0.52 m^2 at the time of study enrollment; patients accruing to dose level 2 must have a body surface area >= 0.37 m^2 at the time of study enrollment; patients accruing to dose level -1 must have a body surface area >= 0.75 m^2 at the time of study enrollment

For patients with solid tumors without known bone marrow involvement: Peripheral absolute neutrophil count (ANC) >= 1000/mm^3; Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests how well samotolisib works in treating patients with metastatic solid tumors, NHL, or histiocytic disorders with TSC or PI3K/MTOR mutations. Samotolisib may stop cancer cell growth by blocking some enzymes needed for cell growth.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in the provided information, drugs like samotolisib typically may cause side effects including fatigue, nausea, diarrhea, blood sugar changes (especially important since those with insulin-dependent diabetes were excluded), rash, liver enzyme elevation which indicates stress on the liver, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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My kidney function is normal or near normal.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate

Secondary study objectives

Percentage of Patients Experiencing Grade 3 or 4 Adverse Events

Pharmacokinetic (PK) of Samotolisib, Area Under the Curve (AUC).

Progression Free Survival (PFS)

Other study objectives

Biallelic Loss of Function Frequency and Mechanism

Change in Tumor Genomic Profile

Potential Predictive Biomarker Identification Using Additional Genomic, Transcriptomic, and Proteomic Testing Platforms

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Computed Tomography

2017

Completed Phase 2

~2740