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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response rate

Secondary outcome measures

Percentage of patients experiencing grade 3 or 4 adverse events

Pharmacokinetic (PK) parameters

Progression free survival (PFS)

Other outcome measures

Chronic Kidney Diseases

Change in tumor genomic profile

Potential predictive biomarker identification using additional genomic, transcriptomic, and proteomic testing platforms

+1 more

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 2

~1730

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,135 Total Patients Enrolled

Theodore W LaetschPrincipal InvestigatorChildren's Oncology Group

1 Previous Clinical Trials

70 Total Patients Enrolled

Media Library

Samotolisib (PI3K/mTOR inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03213678 — Phase 2

Cancer Research Study Groups: Treatment (samotolisib)

Cancer Clinical Trial 2023: Samotolisib Highlights & Side Effects. Trial Name: NCT03213678 — Phase 2

Samotolisib (PI3K/mTOR inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03213678 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any participants currently being accepted for this experiment?

"Affirmative. According to the clinicaltrials.gov information, this investigation is currently searching for participants and was initially advertised on July 31st 2017 with its last amendment made on November 16th 2022. The study seeks 24 patients across 100 sites."

Answered by AI

Is this the inaugural study of its type?

"Pharmacological Study has been subject to research since 2014, when it was first trialed courtesy of Eli Lilly and Company. This inaugural trial involved 198 participants and ultimately led to Phase 1 drug approval for the medication. As of today, 3 trials are currently being conducted in 133 cities across 2 nations."

Answered by AI

Who are the eligible participants for this clinical research project?

"Ideal participants for this trial must have wilms tumor and be aged between 12 months to 21. A total of 24 people are needed as part of the study."

Answered by AI

How extensive is the geographic scope of this experiment?

"This medical trial is currently running at 100 locations, including Madison, Marshfield and San Antonio. To maximize convenience for participants, it is advised to select the closest clinic in order to decrease any commuting needs that may be incurred if one enrolls."

Answered by AI

What potential dangers do participants in this pharmacological trial face?

"The safety of the pharmacological study received a rating of 2. This is due to Phase 2 trial status, with preliminary evidence that it may be safe but no proof yet supporting its effectiveness."

Answered by AI

How many participants are included in the current clinical trial?

"This trial requires 24 eligible candidates to take part. Patients can come from University of Wisconsin Hospital and Clinics in Madison, WI or Marshfield Medical Center- Marshfield in New york."

Answered by AI

What precedent have other investigators set in regards to Pharmacological Study?

"The Pharmacological Study was first recorded in 2014 at the Univ of Pittsburgh Cancer Inst. (UPCI). Since then, a total of 605 investigations have been concluded and 3 more trials are still running. There has been an influx of research conducted from Madison, Wisconsin as well."

Answered by AI

Are those aged 50 or above being accepted into the trial?

"This clinical trial has established that participants must range from 12 months to 21 years of age. There are 1090 studies for individuals below the legal drinking age and 5002 for seniors aged 65 or above."

Answered by AI

Recent research and studies

Expert Opinion on Emerging DrugsJournal

An Update on Emerging Drugs in Osteosarcoma: Towards Tailored Therapies?

Hattinger, Claudia Maria, Maria Pia Patrizio, Federica Magagnoli, Silvia Luppi, and Massimo Serra. 2019. “An Update on Emerging Drugs in Osteosarcoma: Towards Tailored Therapies?”. Expert Opinion on Emerging Drugs. Informa UK Limited. doi:10.1080/14728214.2019.1654455.

clinicaltrials.govStudy

Samotolisib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations (A Pediatric MATCH Treatment Trial)

2017. "Samotolisib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations (A Pediatric MATCH Treatment Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03213678.

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