Akt/ERK Inhibitor ONC201 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Phase I/II Study of Oral ONC201 in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma
Sponsor: M.D. Anderson Cancer Center
Terminated
Per PI Request
Listed as NCT02420795, this PHASE1/PHASE2 trial focuses on Central Nervous System Lymphoma and Gastric Mantle Cell Lymphoma and remains terminated or withdrawn. Sponsored by M.D. Anderson Cancer Center, it has been updated 13 times since 2015, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)PRIMARY OBJECTIVES:
I. To determine recommended phase II dose for oral ONC201 (Akt/ERK inhibitor ONC201) in patients with relapsed/refractory lymphomas. (Phase I) II. To identify toxicities associated with oral ONC201 in patients with relapsed/refractory lymphomas. (Phase I) III. To determine the objective response rate to ONC201 in patients with relapsed/refractory lymphomas. (Phase II)
SECONDARY OBJECTIVES:
I. To determine the pharmacokinetics (PK) of oral ONC201 following administration. (Phase I) II. To observe the anti-tumor effects of oral ONC201, if any occur, in patients with relapsed/refractory lymphomas. (Phase I) III. Confirm tolerability of recommended phase II dose. (Phase II) IV. Assess clinical outcomes associated with ONC201 treatment in patients with relapsed/refractory lymphomas. (Phase II) V. Correlate clinical outcome with tumor and serum biomarkers. (Phase II)
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive Akt/ERK inhibitor ONC201 orally (PO) on day 1 of every cycle or day 1 of every week. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
PRIMARY OBJECTIVES:
I. To determine recommended phase II dose for oral ONC201 (Akt/ERK inhibitor ONC201) in patients with relapsed/refractory lymphomas. (Phase I) II. To identify toxicities associated with oral ONC201 in patients with relapsed/refractory lymphomas. (Phase I) III. To determine the objective response rate to ONC201 in patients with relapsed/refractory lymphomas. (Phase II)
SECONDARY OBJECTIVES:
I. To determine the pharmacokinetics (PK) of oral ONC201 following administration. (Phase I) II. To observe the anti-tumor effects of oral ONC201, if any occur, in patients with relapsed/refractory lymphomas. (Phase I) III. Confirm tolerability of recommended phase II dose. (Phase II) IV. Assess clinical outcomes associated with ONC201 treatment in patients with relapsed/refractory lymphomas. (Phase II) V. Correlate clinical outcome with tumor and serum biomarkers. (Phase II)
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive Akt/ERK inhibitor ONC201 orally (PO) on day 1 of every cycle or day 1 of every week. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
Status Flow
Change History
13 versions recorded-
Jan 2026 — Present [monthly]
Terminated PHASE1/PHASE2
-
Sep 2024 — Present [monthly]
Terminated PHASE1/PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Terminated PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
-
May 2022 — Jul 2024 [monthly]
Terminated PHASE1_PHASE2
-
Jan 2021 — May 2022 [monthly]
Terminated PHASE1_PHASE2
▶ Show 8 earlier versions
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Dec 2020 — Jan 2021 [monthly]
Terminated PHASE1_PHASE2
Status: Recruiting → Terminated
-
Jul 2019 — Dec 2020 [monthly]
Recruiting PHASE1_PHASE2
-
Jun 2019 — Jul 2019 [monthly]
Recruiting PHASE1_PHASE2
-
Dec 2018 — Jun 2019 [monthly]
Recruiting PHASE1_PHASE2
-
Jun 2018 — Dec 2018 [monthly]
Recruiting PHASE1_PHASE2
-
Apr 2017 — Jun 2018 [monthly]
Recruiting PHASE1_PHASE2
Status: Active Not Recruiting → Recruiting
-
Feb 2017 — Apr 2017 [monthly]
Active Not Recruiting PHASE1_PHASE2
-
Jan 2017 — Feb 2017 [monthly]
Active Not Recruiting PHASE1_PHASE2
First recorded
Nov 2015
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .