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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02420795
Recruitment Status : Terminated (Per PI Request)
First Posted : April 20, 2015
Results First Posted : April 4, 2022
Last Update Posted : April 4, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Central Nervous System Lymphoma
Gastric Mantle Cell Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Non-Hodgkin Lymphoma
Refractory Mantle Cell Lymphoma
Refractory Non-Hodgkin Lymphoma
Splenic Mantle Cell Lymphoma
Interventions Drug: Akt/ERK Inhibitor ONC201
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Enrollment 16
Recruitment Details Patients recruited at MD Anderson Lymphoma clinic from November 2015 through April 2018
Pre-assignment Details 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.
Arm/Group Title ONC201 125 mg ONC201 250 mg ONC201 625 mg
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 4 2 5
Completed 0 0 0
Not Completed 4 2 5
Reason Not Completed
Withdrawal by Subject             1             0             0
Adverse Event             1             0             0
Progressive disease             2             2             4
Death             0             0             1
Arm/Group Title ONC201 125 mg ONC201 250 mg ONC201 625 mg Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 4 2 5 11
Hide Baseline Analysis Population Description
Patients enrolled on Arm A until Arm B approved in 2/9/2016 IRB amendment
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 5 participants 11 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  25.0%
0
   0.0%
1
  20.0%
2
  18.2%
>=65 years
3
  75.0%
2
 100.0%
4
  80.0%
9
  81.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 5 participants 11 participants
Female
1
  25.0%
0
   0.0%
2
  40.0%
3
  27.3%
Male
3
  75.0%
2
 100.0%
3
  60.0%
8
  72.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 5 participants 11 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
1
  20.0%
1
   9.1%
Not Hispanic or Latino
3
  75.0%
2
 100.0%
4
  80.0%
9
  81.8%
Unknown or Not Reported
1
  25.0%
0
   0.0%
0
   0.0%
1
   9.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 5 participants 11 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
4
 100.0%
2
 100.0%
5
 100.0%
11
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 2 participants 5 participants 11 participants
4 2 5 11
1.Primary Outcome
Title Recommended Phase 2 Dose (RP2D) (Phase I)
Hide Description [Not Specified]
Time Frame 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ONC201 125 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: mg
125
2.Primary Outcome
Title Number of Participants With Overall Response Rate (Phase 1 and 2)
Hide Description Defined as either progressive disease or stable disease observed assessed by the Revised International Workshop Standardization Response Criteria for non-Hodgkin lymphoma.
Time Frame Up to 63 days (first 3 courses)
Hide Outcome Measure Data
Hide Analysis Population Description
1 patient passed away prior to restaging in Phase 2 Arm B
Arm/Group Title ONC201 125 mg ONC201 250 mg ONC201 625 mg
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 4 2 5
Measure Type: Count of Participants
Unit of Measure: Participants
Progressive Disease
3
  75.0%
1
  50.0%
3
  60.0%
Stable Disease
1
  25.0%
1
  50.0%
1
  20.0%
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival is the time in months from start of study treatment to date of death due to any cause.
Time Frame every 3 months for 1 year, then every 6 months, up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Overall survival for each arm measured in months
Arm/Group Title ONC201 125 mg ONC201 250 mg ONC201 625 mg
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 2 4 5
Median (Full Range)
Unit of Measure: months
29
(1 to 30)
15
(1 to 30)
24
(1 to 48)
4.Secondary Outcome
Title Progression-free Survival (PFS)- (Phase 2)
Hide Description 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 Frame every 3 months for 1 year, then every 6 months, up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ONC201 625 mg
Hide Arm/Group Description:
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 Number of Participants Analyzed 5
Median (Full Range)
Unit of Measure: weeks
5
(1 to 10)
Time Frame From the first dose through every 3 months after the last dose of study medication, up to 1 year.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ONC201 125 mg ONC201 250 mg ONC201 625 mg
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
ONC201 125 mg ONC201 250 mg ONC201 625 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/2 (0.00%)   1/5 (20.00%) 
Hide Serious Adverse Events
ONC201 125 mg ONC201 250 mg ONC201 625 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   1/2 (50.00%)   1/5 (20.00%) 
Blood and lymphatic system disorders       
Anemia † 1  0/4 (0.00%)  1/2 (50.00%)  0/5 (0.00%) 
Blood and lymphatic system disorders- Other † 2  0/4 (0.00%)  1/2 (50.00%)  0/5 (0.00%) 
General disorders       
Dehydration † 2  0/4 (0.00%)  1/2 (50.00%)  0/5 (0.00%) 
Edema Limbs † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Infections and infestations       
Myocardial Infarction † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
1
Term from vocabulary, CTCAE (4.3)
2
Term from vocabulary, MedDRA (12)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
ONC201 125 mg ONC201 250 mg ONC201 625 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/4 (100.00%)   2/2 (100.00%)   5/5 (100.00%) 
Blood and lymphatic system disorders       
Anemia † 2  3/4 (75.00%)  1/2 (50.00%)  0/5 (0.00%) 
Blood and lymphatic system disorder † 2  0/4 (0.00%)  1/2 (50.00%)  0/5 (0.00%) 
Pancytopenia † 2  0/4 (0.00%)  1/2 (50.00%)  0/5 (0.00%) 
Platelet count decreased † 2  1/4 (25.00%)  1/2 (50.00%)  2/5 (40.00%) 
Platelet Count Decreased † 2  1/4 (25.00%)  0/2 (0.00%)  2/5 (40.00%) 
Cardiac disorders       
Myocardial Infarction † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Sinus bradycardia † 2  1/4 (25.00%)  0/2 (0.00%)  0/5 (0.00%) 
Ear and labyrinth disorders       
Ear Pain † 2  1/4 (25.00%)  0/2 (0.00%)  0/5 (0.00%) 
Hearing impaired † 2  0/4 (0.00%)  1/2 (50.00%)  0/5 (0.00%) 
Loss of hearing on right ear † 2  1/4 (25.00%)  0/2 (0.00%)  0/5 (0.00%) 
Endocrine disorders       
Hypothyroidism † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Eye disorders       
Blurred vision † 2  1/4 (25.00%)  0/2 (0.00%)  1/5 (20.00%) 
Redness (both ears) † 2  1/4 (25.00%)  0/2 (0.00%)  0/5 (0.00%) 
Gastrointestinal disorders       
Abdominal pain † 1  0/4 (0.00%)  1/2 (50.00%)  1/5 (20.00%) 
Constipation † 2  1/4 (25.00%)  1/2 (50.00%)  1/5 (20.00%) 
Diarrhea † 2  1/4 (25.00%)  0/2 (0.00%)  4/5 (80.00%) 
Dry mouth † 2  1/4 (25.00%)  0/2 (0.00%)  0/5 (0.00%) 
Dyspepsia † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Dysphagia † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
GI bleeding † 2  0/4 (0.00%)  1/2 (50.00%)  0/5 (0.00%) 
Nausea † 2  1/4 (25.00%)  1/2 (50.00%)  2/5 (40.00%) 
Vomiting † 2  1/4 (25.00%)  0/2 (0.00%)  0/5 (0.00%) 
Acute abdominal pain on lower right † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
General disorders       
AST increased † 2  2/4 (50.00%)  0/2 (0.00%)  0/5 (0.00%) 
Back pain † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Bug bites † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Edema limbs † 2  1/4 (25.00%)  0/2 (0.00%)  3/5 (60.00%) 
Edema trunk † 2  1/4 (25.00%)  0/2 (0.00%)  0/5 (0.00%) 
Elevated LDH † 2  0/4 (0.00%)  1/2 (50.00%)  0/5 (0.00%) 
Fatigue † 2  3/4 (75.00%)  2/2 (100.00%)  4/5 (80.00%) 
Fever † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Pain † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Right carotid artery disease † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Runny nose † 2  0/4 (0.00%)  1/2 (50.00%)  0/5 (0.00%) 
Weakness † 2  0/4 (0.00%)  0/2 (0.00%)  2/5 (40.00%) 
Alkaline phosphatase increased (ALT) † 2  1/4 (25.00%)  0/2 (0.00%)  0/5 (0.00%) 
Left hip and thigh pain † 2  1/4 (25.00%)  0/2 (0.00%)  0/5 (0.00%) 
Left lower back pain † 2  1/4 (25.00%)  0/2 (0.00%)  0/5 (0.00%) 
Left lower leg pain † 2  1/4 (25.00%)  0/2 (0.00%)  0/5 (0.00%) 
Left quadrant abdominal pain † 2  1/4 (25.00%)  0/2 (0.00%)  0/5 (0.00%) 
Left shoulder pain † 2  1/4 (25.00%)  0/2 (0.00%)  0/5 (0.00%) 
Legs Muscle Cramps † 2  1/4 (25.00%)  0/2 (0.00%)  0/5 (0.00%) 
Right Hip Pain † 2  2/4 (50.00%)  0/2 (0.00%)  0/5 (0.00%) 
Right Upper Quadrant Pain † 2  1/4 (25.00%)  0/2 (0.00%)  0/5 (0.00%) 
Infections and infestations       
Splenomegaly † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Thrush † 2  0/4 (0.00%)  1/2 (50.00%)  0/5 (0.00%) 
Oral Thrush † 2  1/4 (25.00%)  0/2 (0.00%)  0/5 (0.00%) 
Injury, poisoning and procedural complications       
Fall † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Investigations       
Creatinine increased † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Neutrophil count decreased † 2  0/4 (0.00%)  1/2 (50.00%)  1/5 (20.00%) 
Weight loss † 2  0/4 (0.00%)  0/2 (0.00%)  2/5 (40.00%) 
Metabolism and nutrition disorders       
Appetite change † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Dehydration † 2  0/4 (0.00%)  1/2 (50.00%)  1/5 (20.00%) 
Hypercalcemia † 2  1/4 (25.00%)  1/2 (50.00%)  0/5 (0.00%) 
Hyperglycemia † 2  1/4 (25.00%)  1/2 (50.00%)  1/5 (20.00%) 
Hyperkalemia † 2  1/4 (25.00%)  1/2 (50.00%)  1/5 (20.00%) 
Hyperuricemia † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Hypomagnesemia † 2  0/4 (0.00%)  1/2 (50.00%)  1/5 (20.00%) 
Hyponatremia † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Musculoskeletal and connective tissue disorders       
Myalgia † 2  2/4 (50.00%)  1/2 (50.00%)  1/5 (20.00%) 
Left ankle † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Nervous system disorders       
Anxiety † 2  0/4 (0.00%)  0/2 (0.00%)  2/5 (40.00%) 
Dizziness † 2  0/4 (0.00%)  0/2 (0.00%)  2/5 (40.00%) 
Peripheral Sensory Neuoropathy † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Numbness † 2  1/4 (25.00%)  0/2 (0.00%)  0/5 (0.00%) 
Numbness/Tingling † 2  0/4 (0.00%)  2/2 (100.00%)  0/5 (0.00%) 
Psychiatric disorders       
Insomnia † 1  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Memory changes † 2  0/4 (0.00%)  1/2 (50.00%)  1/5 (20.00%) 
Memory impairment † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Sleep disturbance † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Renal and urinary disorders       
BUN increased † 2  1/4 (25.00%)  0/2 (0.00%)  0/5 (0.00%) 
Hematuria † 2  1/4 (25.00%)  0/2 (0.00%)  0/5 (0.00%) 
Renal insufficiency † 2  1/4 (25.00%)  1/2 (50.00%)  0/5 (0.00%) 
Chronic kidney disease (creatinine increased) † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough † 2  0/4 (0.00%)  1/2 (50.00%)  0/5 (0.00%) 
Dyspnea † 2  1/4 (25.00%)  1/2 (50.00%)  1/5 (20.00%) 
Pleural Effusion † 2  0/4 (0.00%)  1/2 (50.00%)  0/5 (0.00%) 
Seasonal allergies † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Sore throat † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Wheezing † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Skin and subcutaneous tissue disorders       
Rash maculo-papular † 2  1/4 (25.00%)  0/2 (0.00%)  0/5 (0.00%) 
Ecchymosis (bilateral forearms) † 2  0/4 (0.00%)  0/2 (0.00%)  1/5 (20.00%) 
Vascular disorders       
Hypertension † 2  1/4 (25.00%)  1/2 (50.00%)  1/5 (20.00%) 
1
Term from vocabulary, CTCAE (4.3)
2
Term from vocabulary, MedDRA (12)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Wang, MD, Professor, Lymphoma-Myeloma
Organization: UT MD Anderson Cancer Center
Phone: (713) 792-2860
EMail: miwang@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02420795    
Other Study ID Numbers: 2014-0630
NCI-2015-00706 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
204666
20152142
1-909048-1
1159132
2014-0630 ( Other Identifier: M D Anderson Cancer Center )
First Submitted: April 15, 2015
First Posted: April 20, 2015
Results First Submitted: November 10, 2021
Results First Posted: April 4, 2022
Last Update Posted: April 4, 2022