Trial Outcomes & Findings for Imexon for Relapsed Follicular and Aggressive Lymphomas (NCT NCT01314014)

Last Updated: 2016-01-06

Results Overview

CT, PET, or MRI scans for the assessment of objective tumor responses were performed at baseline, after cycle 2, and every 3 cycles thereafter until disease progression. Standard response criteria from the International Harmonization Project on Lymphoma were used for classification of objective tumor responses. Response was defined as PR (Regression of measuable disease and no new sites) if \>= 50% decrease in sum of the product of the diameters of up to 6 largest dominant masses; no increase in size of other nodes (a) \[18F\]fluorodeoxyglucose (FDG)-avid or PET prior to therapy; one or more (PET) positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

One year

Results posted on

2016-01-06

Participant Flow

Recruitment for this study occured at two academic medical centers (University of Rochester and Arizona Cancer Center) from June 7, 2011 through March 4, 2013.

Participant milestones

Participant milestones
Measure	Imexon Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes. Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment.
Overall Study STARTED	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Imexon for Relapsed Follicular and Aggressive Lymphomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Imexon n=22 Participants Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes. Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment.
Age, Continuous	64 years n=99 Participants
Sex: Female, Male Female	9 Participants n=99 Participants
Sex: Female, Male Male	13 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	22 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	22 participants n=99 Participants

PRIMARY outcome

Timeframe: One year

Population: 20 subjects were evaluable for response, 2 subjects discontinued therapy during cycle 1 due to progressive disease and grade 5 sepsis respectively.

Outcome measures

Outcome measures
Measure	Imexon n=20 Participants Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes. Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment.
Overall Response Rate of of Participants to Imexon in the Treatment of Relapsed/Refractory Indolent and Aggressive Lymphomas	30 percentage of participants Interval 9.9 to 50.1

SECONDARY outcome

Timeframe: up to 25 months

Population: 20 subjects were evaluable for response, 2 subjects discontinued therapy during cycle 1 due to progressive disease and grade 5 sepsis respectively.

Measured from start of treatment until disease progression or death from any cause.

Outcome measures

Outcome measures
Measure	Imexon n=20 Participants Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes. Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment.
Median Time to Progression Free Survival in Participants With Relapsed/Refractory Indolent and Aggressive Lymphomas	2.4 months Interval 1.2 to 9.0

Adverse Events

Imexon

Serious events: 9 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Imexon n=22 participants at risk Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes. Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment.
Gastrointestinal disorders Vomiting	9.1% 2/22 • Number of events 2 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Respiratory, thoracic and mediastinal disorders Bronchial infection	4.5% 1/22 • Number of events 1 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Investigations Creatinine increased	4.5% 1/22 • Number of events 1 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Metabolism and nutrition disorders Dehydration	4.5% 1/22 • Number of events 1 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Renal and urinary disorders Hyperuricemia	4.5% 1/22 • Number of events 1 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Vascular disorders Hypotension	4.5% 1/22 • Number of events 1 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Infections and infestations Lung infection	4.5% 1/22 • Number of events 1 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.5% 1/22 • Number of events 1 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Infections and infestations Sepsis	9.1% 2/22 • Number of events 2 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Nervous system disorders Transient ischemic attack	4.5% 1/22 • Number of events 1 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Infections and infestations Urinary tract infection	4.5% 1/22 • Number of events 1 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.

Other adverse events

Other adverse events
Measure	Imexon n=22 participants at risk Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes. Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment.
General disorders Fatigue	90.9% 20/22 • Number of events 26 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Gastrointestinal disorders Diarrhea	72.7% 16/22 • Number of events 28 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Gastrointestinal disorders Nausea	68.2% 15/22 • Number of events 23 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Blood and lymphatic system disorders Anemia	50.0% 11/22 • Number of events 29 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
General disorders Fever	45.5% 10/22 • Number of events 14 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Gastrointestinal disorders Constipation	40.9% 9/22 • Number of events 11 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Blood and lymphatic system disorders White blood cell decreased	36.4% 8/22 • Number of events 14 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Blood and lymphatic system disorders Platelet count decreased	36.4% 8/22 • Number of events 19 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Gastrointestinal disorders Vomiting	27.3% 6/22 • Number of events 7 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Metabolism and nutrition disorders Anorexia	36.4% 8/22 • Number of events 10 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Respiratory, thoracic and mediastinal disorders Cough	36.4% 8/22 • Number of events 8 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
General disorders Chills	31.8% 7/22 • Number of events 7 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Metabolism and nutrition disorders Hypocalcemia	27.3% 6/22 • Number of events 11 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Investigations Neutrophil count decreased	22.7% 5/22 • Number of events 18 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Infections and infestations Respiratory infection	18.2% 4/22 • Number of events 6 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Metabolism and nutrition disorders Dehydration	22.7% 5/22 • Number of events 5 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Vascular disorders Hypotension	18.2% 4/22 • Number of events 4 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Investigations Weight loss	22.7% 5/22 • Number of events 7 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Gastrointestinal disorders Abdominal pain	22.7% 5/22 • Number of events 6 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Nervous system disorders Headache	22.7% 5/22 • Number of events 5 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Respiratory, thoracic and mediastinal disorders Dyspnea	18.2% 4/22 • Number of events 4 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Investigations Creatinine increased	13.6% 3/22 • Number of events 4 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Nervous system disorders Dysgeusia	18.2% 4/22 • Number of events 4 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
General disorders Malaise	18.2% 4/22 • Number of events 4 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Metabolism and nutrition disorders Hypoalbuminemia	18.2% 4/22 • Number of events 7 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
General disorders Edema limbs	18.2% 4/22 • Number of events 4 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	13.6% 3/22 • Number of events 3 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Skin and subcutaneous tissue disorders Rash	13.6% 3/22 • Number of events 4 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Psychiatric disorders Insomnia	13.6% 3/22 • Number of events 3 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Nervous system disorders Paresthesia	13.6% 3/22 • Number of events 4 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Gastrointestinal disorders Oral dysesthesia	13.6% 3/22 • Number of events 3 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Investigations Alanine aminotransferase increased	13.6% 3/22 • Number of events 4 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.
Musculoskeletal and connective tissue disorders Back pain	13.6% 3/22 • Number of events 3 • From first dose of study treatment through 30 days after last dose. For each subject, AE recording began on Day 1 of the first treatment cycle, and continued until the subject completed the protocol or withdrew from the study for any reason. AEs were followed clinically until they resolved or 30 days after the last dose of study drug was received, whichever occured first.

Additional Information

Paul M. Barr, MD

James P. Wilmot Cancer Center, University of Rochester

Phone: 585-273-3258

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place