TriangleNCT02420795 · STUDY IN CONTEXT
Akt/ERK Inhibitor ONC201 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Recommended Phase 2 Dose (RP2D) (Phase I)
Defined as either progressive disease or stable disease observed assessed by the Revised International Workshop Standardization Response Criteria for non-Hodgkin lymphoma.
Overall survival is the time in months from start of study treatment to date of death due to any cause.
Progression free survival is defined as time in weeks from start of study treatment to first documentation of objective tumor progression or up to death due to any cause, whichever occurs first.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT02420795
- trial label
- Akt/ERK Inhibitor ONC201 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 4
- harms Count
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT02420795
- outcome key
- om-0000
- source section id
- NCT02420795-om-0000
- source outcome index
- 0
- endpoint
- Recommended Phase 2 Dose (RP2D) (Phase I)
- endpoint definition
- Recommended Phase 2 Dose (RP2D) (Phase I)
- time origin
- 21 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT02420795
- outcome key
- om-0001
- source section id
- NCT02420795-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants With Overall Response Rate (Phase 1 and 2)
- endpoint definition
- Defined as either progressive disease or stable disease observed assessed by the Revised International Workshop Standardization Response Criteria for non-Hodgkin lymphoma.
- time origin
- Up to 63 days (first 3 courses)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 1 patient passed away prior to restaging in Phase 2 Arm B
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT02420795
- outcome key
- om-0002
- source section id
- NCT02420795-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival (OS)
- endpoint definition
- Overall survival is the time in months from start of study treatment to date of death due to any cause.
- time origin
- every 3 months for 1 year, then every 6 months, up to 3 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Overall survival for each arm measured in months
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT02420795
- outcome key
- om-0003
- source section id
- NCT02420795-om-0003
- source outcome index
- 3
- endpoint
- Progression-free Survival (PFS)- (Phase 2)
- endpoint definition
- Progression free survival is defined as time in weeks from start of study treatment to first documentation of objective tumor progression or up to death due to any cause, whichever occurs first.
- time origin
- every 3 months for 1 year, then every 6 months, up to 6 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT02420795
- outcome key
- om-0000
- arm key
- OG000
- arm label
- ONC201 125 mg
- regimen
- Patients receive Akt/ERK inhibitor ONC201 125 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02420795-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT02420795
- outcome key
- om-0001
- arm key
- OG000
- arm label
- ONC201 125 mg
- regimen
- Patients receive Akt/ERK inhibitor ONC201 125 mg PO on day 1 of every cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02420795-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT02420795
- outcome key
- om-0001
- arm key
- OG001
- arm label
- ONC201 250 mg
- regimen
- Patients receive Akt/ERK inhibitor ONC201 250 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02420795-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT02420795
- outcome key
- om-0001
- arm key
- OG002
- arm label
- ONC201 625 mg
- regimen
- Patients receive Akt/ERK inhibitor ONC201 625 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02420795-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT02420795
- outcome key
- om-0002
- arm key
- OG000
- arm label
- ONC201 125 mg
- regimen
- Patients receive Akt/ERK inhibitor ONC201 125 mg PO on day 1 of every cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02420795-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT02420795
- outcome key
- om-0002
- arm key
- OG001
- arm label
- ONC201 250 mg
- regimen
- Patients receive Akt/ERK inhibitor ONC201 250 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02420795-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT02420795
- outcome key
- om-0002
- arm key
- OG002
- arm label
- ONC201 625 mg
- regimen
- Patients receive Akt/ERK inhibitor ONC201 625 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02420795-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT02420795
- outcome key
- om-0003
- arm key
- OG000
- arm label
- ONC201 625 mg
- regimen
- Patients receive Akt/ERK inhibitor ONC201 625 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02420795-om-0003#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT02420795
- harm key
- EG000
- source section id
- NCT02420795-ae
- event group key
- EG000
- event group label
- ONC201 125 mg
- serious affected
- 0
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 1
- collection period
- From the first dose through every 3 months after the last dose of study medication, up to 1 year.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT02420795
- harm key
- EG001
- source section id
- NCT02420795-ae
- event group key
- EG001
- event group label
- ONC201 250 mg
- serious affected
- 1
- serious at risk
- 2
- other affected
- 2
- other at risk
- 2
- frequency threshold
- 1
- collection period
- From the first dose through every 3 months after the last dose of study medication, up to 1 year.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-central-nervous-system-lymphoma
- nct id
- NCT02420795
- harm key
- EG002
- source section id
- NCT02420795-ae
- event group key
- EG002
- event group label
- ONC201 625 mg
- serious affected
- 1
- serious at risk
- 5
- other affected
- 5
- other at risk
- 5
- frequency threshold
- 1
- collection period
- From the first dose through every 3 months after the last dose of study medication, up to 1 year.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice