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Small Molecule

ONC201 for Leukemia

Phase 1 & 2

Recruiting

Led By Gautam Borthakur, MBBS

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

For Arms A, B, C, D, E patients must have relapsed or refractory acute leukemias or high-risk MDS for which no standard therapies are anticipated to result in a durable remission

Age >= 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 63 days

Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it works well and what the side effects are.

Who is the study for?

Adults over 18 with acute leukemia or high-risk myelodysplastic syndrome that's relapsed or refractory. They must be in fair health (ECOG 0-2), able to consent, and have no severe persistent side effects from past treatments. No recent heart issues, other cancer treatments within 3 years (except certain low-risk cases), or active infections like HIV/Hepatitis B/C.Check my eligibility

What is being tested?

The trial is testing ONC201, a drug thought to block enzymes that cancer cells need to grow. It aims to find the safest dose and see how effective it is for patients whose disease has returned after treatment or hasn't responded at all.See study design

What are the potential side effects?

Possible side effects of ONC201 include reactions related to stopping cancer cell growth which may affect normal cells too. Specific side effects aren't listed but generally could involve fatigue, nausea, liver enzyme changes, and others as seen with similar drugs.

Eligibility Criteria

Inclusion Criteria

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

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My leukemia or high-risk MDS has not responded to standard treatments.

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 63 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~63 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 63 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Maximum Tolerated Dose (MTD) of ONOC201 in Relapsed or Refractory Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome (MDS) or Acute Lymphoblastic Leukemia (ALL)

Objective Response (OR) (Phase II)

Secondary outcome measures

Objective Response (OR)

Trial Design

5Treatment groups

Experimental Treatment

Group I: Arm E (Akt/ERK inhibitor ONC201)Experimental Treatment1 Intervention

Patients receive Akt/ERK inhibitor ONC201 PO twice weekly. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm D (Akt/ERK inhibitor ONC201)Experimental Treatment1 Intervention

Patients receive Akt/ERK inhibitor ONC201 PO QD. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group III: Arm C (Akt/ERK inhibitor ONC201)Experimental Treatment1 Intervention

Patients receive Akt/ERK inhibitor ONC201 PO on the first two consecutive days of every week. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group IV: Arm B (Akt/ERK inhibitor ONC201)Experimental Treatment1 Intervention

Patients receive Akt/ERK inhibitor ONC201 PO once every week. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group V: Arm A (Akt/ERK inhibitor ONC201)Experimental Treatment1 Intervention

Patients receive Akt/ERK inhibitor ONC201 PO once every 3 weeks. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,201 Total Patients Enrolled

Oncoceutics, Inc.Industry Sponsor

5 Previous Clinical Trials

116 Total Patients Enrolled

Gautam Borthakur, MBBSPrincipal InvestigatorM.D. Anderson Cancer Center

8 Previous Clinical Trials

178 Total Patients Enrolled

Media Library

ONC201 (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT02392572 — Phase 1 & 2

Acute Lymphoblastic Leukemia Research Study Groups: Arm A (Akt/ERK inhibitor ONC201), Arm B (Akt/ERK inhibitor ONC201), Arm D (Akt/ERK inhibitor ONC201), Arm C (Akt/ERK inhibitor ONC201), Arm E (Akt/ERK inhibitor ONC201)

Acute Lymphoblastic Leukemia Clinical Trial 2023: ONC201 Highlights & Side Effects. Trial Name: NCT02392572 — Phase 1 & 2

ONC201 (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02392572 — Phase 1 & 2

Frequently Asked Questions

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

What pathologies has ONC201 been utilized to address?

"ONC201 is a viable therapy for leptomeningeal metastases, acute promyelocytic leukemia and meningeal leukemia."

Answered by AI

What is the aggregate figure of participants in this trial?

"Affirmative. According to the information on clinicaltrials.gov, this study is actively looking for volunteers and has been since November 3rd 2015. There are two sites participating in this trial with a goal of recruiting 120 participants overall by September 22nd 2022."

Answered by AI

Has there been any past experimentation with ONC201?

"Currently, 242 studies are exploring the efficacy of ONC201 with 60 trials in Phase 3. The vast majority of these experiments are held within New york; however, there is a total of 9835 sites running relevant research globally."

Answered by AI

Are there any openings currently available for this experiment?

"Data hosted on clinicaltrials.gov exhibits that this medical experiment is currently looking for participants, having been posted originally in November of 2015 and most recently adjusted in September 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ONC201 in Treating Patients With Relapsed or Refractory Acute Leukemia or High-Risk Myelodysplastic Syndrome

2015. "ONC201 in Treating Patients With Relapsed or Refractory Acute Leukemia or High-Risk Myelodysplastic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02392572.