Trial Outcomes & Findings for Akt/ERK Inhibitor ONC201 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NCT NCT02420795)

NCT ID: NCT02420795

Last Updated: 2022-04-04

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

16 participants

Primary outcome timeframe

21 days

Results posted on

2022-04-04

Participant Flow

Patients recruited at MD Anderson Lymphoma clinic from November 2015 through April 2018

A total of 16 participants consented for the protocol, 11 participated on the study, 4 of the participants were screen failures and 1 withdrew consent.

Participant milestones

Participant milestones
Measure	ONC201 125 mg 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.	ONC201 250 mg 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.	ONC201 625 mg 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.
Overall Study STARTED	4	2	5
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	4	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	ONC201 125 mg 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.	ONC201 250 mg 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.	ONC201 625 mg 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.
Overall Study Withdrawal by Subject	1	0	0
Overall Study Adverse Event	1	0	0
Overall Study Progressive disease	2	2	4
Overall Study Death	0	0	1

Baseline Characteristics

Akt/ERK Inhibitor ONC201 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ONC201 125 mg n=4 Participants 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.	ONC201 250 mg n=2 Participants 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.	ONC201 625 mg n=5 Participants 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.	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	11 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	4 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants	11 participants n=4 Participants

PRIMARY outcome

Timeframe: 21 days

Outcome measures

Outcome measures
Measure	ONC201 125 mg n=4 Participants 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.	ONC201 250 mg 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.	ONC201 625 mg 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.
Recommended Phase 2 Dose (RP2D) (Phase I)	125 mg	—	—

PRIMARY outcome

Timeframe: Up to 63 days (first 3 courses)

Population: 1 patient passed away prior to restaging in Phase 2 Arm B

Defined as either progressive disease or stable disease observed assessed by the Revised International Workshop Standardization Response Criteria for non-Hodgkin lymphoma.

Outcome measures

Outcome measures
Measure	ONC201 125 mg n=4 Participants 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.	ONC201 250 mg n=2 Participants 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.	ONC201 625 mg n=5 Participants 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.
Number of Participants With Overall Response Rate (Phase 1 and 2) Progressive Disease	3 Participants	1 Participants	3 Participants
Number of Participants With Overall Response Rate (Phase 1 and 2) Stable Disease	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: every 3 months for 1 year, then every 6 months, up to 3 years

Population: Overall survival for each arm measured in months

Overall survival is the time in months from start of study treatment to date of death due to any cause.

Outcome measures

Outcome measures
Measure	ONC201 125 mg n=2 Participants 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.	ONC201 250 mg n=4 Participants 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.	ONC201 625 mg n=5 Participants 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.
Overall Survival (OS)	29 months Interval 1.0 to 30.0	15 months Interval 1.0 to 30.0	24 months Interval 1.0 to 48.0

SECONDARY outcome

Timeframe: every 3 months for 1 year, then every 6 months, up to 6 years

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.

Outcome measures

Outcome measures
Measure	ONC201 125 mg n=5 Participants 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.	ONC201 250 mg 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.	ONC201 625 mg 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.
Progression-free Survival (PFS)- (Phase 2)	5 weeks Interval 1.0 to 10.0	—	—

Adverse Events

ONC201 125 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

ONC201 250 mg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

ONC201 625 mg

Serious events: 1 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	ONC201 125 mg n=4 participants at risk 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.	ONC201 250 mg n=2 participants at risk 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.	ONC201 625 mg n=5 participants at risk 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.
Blood and lymphatic system disorders Anemia	0.00% 0/4 • From the first dose through every 3 months after the last dose of study medication, up to 1 year.	50.0% 1/2 • From the first dose through every 3 months after the last dose of study medication, up to 1 year.	0.00% 0/5 • From the first dose through every 3 months after the last dose of study medication, up to 1 year.
General disorders Dehydration	0.00% 0/4 • From the first dose through every 3 months after the last dose of study medication, up to 1 year.	50.0% 1/2 • From the first dose through every 3 months after the last dose of study medication, up to 1 year.	0.00% 0/5 • From the first dose through every 3 months after the last dose of study medication, up to 1 year.
Blood and lymphatic system disorders Blood and lymphatic system disorders- Other	0.00% 0/4 • From the first dose through every 3 months after the last dose of study medication, up to 1 year.	50.0% 1/2 • From the first dose through every 3 months after the last dose of study medication, up to 1 year.	0.00% 0/5 • From the first dose through every 3 months after the last dose of study medication, up to 1 year.
Infections and infestations Myocardial Infarction	0.00% 0/4 • From the first dose through every 3 months after the last dose of study medication, up to 1 year.	0.00% 0/2 • From the first dose through every 3 months after the last dose of study medication, up to 1 year.	20.0% 1/5 • From the first dose through every 3 months after the last dose of study medication, up to 1 year.
General disorders Edema Limbs	0.00% 0/4 • From the first dose through every 3 months after the last dose of study medication, up to 1 year.	0.00% 0/2 • From the first dose through every 3 months after the last dose of study medication, up to 1 year.	20.0% 1/5 • From the first dose through every 3 months after the last dose of study medication, up to 1 year.

Other adverse events

Additional Information

Michael Wang, MD, Professor, Lymphoma-Myeloma

UT MD Anderson Cancer Center

Phone: (713) 792-2860

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place