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Terminated PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT02420795

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

Updated 13 times since 2017 Last updated: Mar 30, 2022 Started: Nov 3, 2015 Primary completion: Nov 16, 2020 Completion: Nov 16, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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trial focuses on Central Nervous System Lymphoma and Gastric Mantle Cell Lymphoma and remains terminated or withdrawn.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

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Apr 2017 · 59 days · monthly snapshot~Apr 2017 – ~Jun 2018 · 14 months · monthly snapshot~Jun 2018 – ~Dec 2018 · 6 months · monthly snapshot~Dec 2018 – ~Jun 2019 · 6 months · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Dec 2020 · 17 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~May 2022 · 16 months · monthly snapshot~May 2022 – ~Jul 2024 · 26 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 19 months · monthly snapshot~Jan 2026 – present · 3 months · monthly snapshot

Change History

13 versions recorded
  1. Jan 2026 — Present [monthly]

    Terminated PHASE1/PHASE2

  2. Sep 2024 — Present [monthly]

    Terminated PHASE1/PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  4. May 2022 — Jul 2024 [monthly]

    Terminated PHASE1_PHASE2

  5. Jan 2021 — May 2022 [monthly]

    Terminated PHASE1_PHASE2

Show 8 earlier versions
  1. Dec 2020 — Jan 2021 [monthly]

    Terminated PHASE1_PHASE2

    Status: RecruitingTerminated

  2. Jul 2019 — Dec 2020 [monthly]

    Recruiting PHASE1_PHASE2

  3. Jun 2019 — Jul 2019 [monthly]

    Recruiting PHASE1_PHASE2

  4. Dec 2018 — Jun 2019 [monthly]

    Recruiting PHASE1_PHASE2

  5. Jun 2018 — Dec 2018 [monthly]

    Recruiting PHASE1_PHASE2

  6. Apr 2017 — Jun 2018 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Active Not RecruitingRecruiting

  7. Feb 2017 — Apr 2017 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  8. 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

Sponsor contact:
  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
Data source: M.D. Anderson Cancer Center

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations