Trial Outcomes & Findings for FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NCT NCT00383565)
NCT ID: NCT00383565
Last Updated: 2014-05-20
Results Overview
International Working Group response for non- Hodgkin's lymphoma: Complete Response (CR) - disappearance all detectable clinical/radiographic evidence of disease and disappearance of all disease-related symptoms (present before therapy) and normalization of those biochemical abnormalities; Partial Response (PR) - ≥50% decrease in sum products of greatest diameters (SPD) of 6 largest dominant nodes or nodal masses, selected by clearly measurable in at least two perpendicular dimensions, from disparate regions of body and no decrease in size of other nodes, liver, or spleen.
TERMINATED
PHASE2
9 participants
24 weeks (6 courses of 4 week cycles)
2014-05-20
Participant Flow
Recruitment Period: September 20, 2006 to May 08, 2009. All recruitment done at UT MD Anderson Cancer Center.
Participant milestones
| Measure |
FR901228
13 mg/m\^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
FR901228
n=9 Participants
13 mg/m\^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
66.8 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeks (6 courses of 4 week cycles)International Working Group response for non- Hodgkin's lymphoma: Complete Response (CR) - disappearance all detectable clinical/radiographic evidence of disease and disappearance of all disease-related symptoms (present before therapy) and normalization of those biochemical abnormalities; Partial Response (PR) - ≥50% decrease in sum products of greatest diameters (SPD) of 6 largest dominant nodes or nodal masses, selected by clearly measurable in at least two perpendicular dimensions, from disparate regions of body and no decrease in size of other nodes, liver, or spleen.
Outcome measures
| Measure |
FR901228
n=9 Participants
13 mg/m\^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
|
|---|---|
|
Overall Objective Response Rate (Complete Response [CR] and Partial Response [PR]) After 6 Courses of Treatment
Complete Response
|
0 participants
|
|
Overall Objective Response Rate (Complete Response [CR] and Partial Response [PR]) After 6 Courses of Treatment
Partial Response
|
1 participants
|
SECONDARY outcome
Timeframe: 2 YearsTime to disease progression is defined as the time from registration to documentation of disease progression.
Outcome measures
| Measure |
FR901228
n=9 Participants
13 mg/m\^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
|
|---|---|
|
Median Progression Free-survival (PFS)
|
4 months
Interval 1.0 to 7.0
|
SECONDARY outcome
Timeframe: 5 YearsSurvival time is defined as the time from registration to death due to any cause, measured in months. The distribution of survival time estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
FR901228
n=9 Participants
13 mg/m\^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
|
|---|---|
|
Median Overall Survival
|
20 months
Interval 1.0 to 53.0
|
Adverse Events
FR901228
Serious adverse events
| Measure |
FR901228
n=9 participants at risk
13 mg/m\^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
|
|---|---|
|
Infections and infestations
Neutropenia
|
11.1%
1/9 • 3 years and 9 months
|
|
Infections and infestations
Thrombocytopenia
|
22.2%
2/9 • 3 years and 9 months
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
1/9 • 3 years and 9 months
|
|
Metabolism and nutrition disorders
Glucose, serum-high
|
11.1%
1/9 • 3 years and 9 months
|
|
Infections and infestations
Infection
|
11.1%
1/9 • 3 years and 9 months
|
|
Eye disorders
Diplopia
|
11.1%
1/9 • 3 years and 9 months
|
|
Metabolism and nutrition disorders
Increased Alkaline phosphatase
|
11.1%
1/9 • 3 years and 9 months
|
|
Cardiac disorders
Cardiac Arrhythmia
|
11.1%
1/9 • 3 years and 9 months
|
|
General disorders
Death NOS
|
11.1%
1/9 • 3 years and 9 months
|
|
Cardiac disorders
Infectious Endocarditis
|
11.1%
1/9 • 3 years and 9 months
|
|
General disorders
Non-neutropenic fever
|
11.1%
1/9 • 3 years and 9 months
|
|
Vascular disorders
DVT, Vascular access-related
|
11.1%
1/9 • 3 years and 9 months
|
|
General disorders
Fatigue
|
11.1%
1/9 • 3 years and 9 months
|
Other adverse events
| Measure |
FR901228
n=9 participants at risk
13 mg/m\^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
|
|---|---|
|
Investigations
weight loss
|
22.2%
2/9 • 3 years and 9 months
|
|
Gastrointestinal disorders
nausea
|
66.7%
6/9 • 3 years and 9 months
|
|
General disorders
fatigue
|
55.6%
5/9 • 3 years and 9 months
|
|
Investigations
thrombocytopenia
|
88.9%
8/9 • 3 years and 9 months
|
|
Blood and lymphatic system disorders
anemia
|
77.8%
7/9 • 3 years and 9 months
|
|
Metabolism and nutrition disorders
hyperglycemia
|
44.4%
4/9 • 3 years and 9 months
|
|
Metabolism and nutrition disorders
anorexia
|
22.2%
2/9 • 3 years and 9 months
|
|
Metabolism and nutrition disorders
hypocalcemia
|
22.2%
2/9 • 3 years and 9 months
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
44.4%
4/9 • 3 years and 9 months
|
|
Metabolism and nutrition disorders
hyperuricemia
|
11.1%
1/9 • 3 years and 9 months
|
|
Metabolism and nutrition disorders
hypoglycemia
|
11.1%
1/9 • 3 years and 9 months
|
|
Metabolism and nutrition disorders
hyperkalemia
|
44.4%
4/9 • 3 years and 9 months
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
22.2%
2/9 • 3 years and 9 months
|
|
Metabolism and nutrition disorders
hyponatremia
|
22.2%
2/9 • 3 years and 9 months
|
|
Eye disorders
blurry vision
|
22.2%
2/9 • 3 years and 9 months
|
|
Gastrointestinal disorders
constipation
|
33.3%
3/9 • 3 years and 9 months
|
|
Gastrointestinal disorders
diarrhea
|
33.3%
3/9 • 3 years and 9 months
|
|
Gastrointestinal disorders
gastritis
|
11.1%
1/9 • 3 years and 9 months
|
|
Gastrointestinal disorders
hemorrhoids
|
11.1%
1/9 • 3 years and 9 months
|
|
Gastrointestinal disorders
mucositis oral
|
11.1%
1/9 • 3 years and 9 months
|
|
Gastrointestinal disorders
oral pain
|
11.1%
1/9 • 3 years and 9 months
|
|
Gastrointestinal disorders
periodontal disease
|
11.1%
1/9 • 3 years and 9 months
|
|
Gastrointestinal disorders
rectal pain
|
11.1%
1/9 • 3 years and 9 months
|
|
Gastrointestinal disorders
stomach pain
|
11.1%
1/9 • 3 years and 9 months
|
|
Gastrointestinal disorders
vomiting
|
33.3%
3/9 • 3 years and 9 months
|
|
General disorders
fever
|
22.2%
2/9 • 3 years and 9 months
|
|
General disorders
edema limbs
|
22.2%
2/9 • 3 years and 9 months
|
|
Infections and infestations
infection with normal Absolute neutrophil count (ANC)
|
77.8%
7/9 • 3 years and 9 months
|
|
Infections and infestations
sinusitis
|
11.1%
1/9 • 3 years and 9 months
|
|
Investigations
alanine aminotransferase (ALT)
|
22.2%
2/9 • 3 years and 9 months
|
|
Investigations
aspartate aminotransferase (AST)
|
33.3%
3/9 • 3 years and 9 months
|
|
Investigations
alkaline phosphatase
|
33.3%
3/9 • 3 years and 9 months
|
|
Investigations
creatinine
|
11.1%
1/9 • 3 years and 9 months
|
|
Investigations
lymphopenia
|
66.7%
6/9 • 3 years and 9 months
|
|
Investigations
leukopenia
|
33.3%
3/9 • 3 years and 9 months
|
|
Investigations
neutropenia
|
22.2%
2/9 • 3 years and 9 months
|
|
Vascular disorders
hypotension
|
11.1%
1/9 • 3 years and 9 months
|
|
Nervous system disorders
sensory neuropathy
|
22.2%
2/9 • 3 years and 9 months
|
|
Nervous system disorders
dizziness
|
22.2%
2/9 • 3 years and 9 months
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
33.3%
3/9 • 3 years and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
11.1%
1/9 • 3 years and 9 months
|
|
Cardiac disorders
sinus tachycardia
|
11.1%
1/9 • 3 years and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
11.1%
1/9 • 3 years and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
11.1%
1/9 • 3 years and 9 months
|
|
Gastrointestinal disorders
taste alteration
|
11.1%
1/9 • 3 years and 9 months
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
33.3%
3/9 • 3 years and 9 months
|
|
Nervous system disorders
headache
|
11.1%
1/9 • 3 years and 9 months
|
|
Skin and subcutaneous tissue disorders
pruritus
|
11.1%
1/9 • 3 years and 9 months
|
|
Vascular disorders
thrombosis
|
11.1%
1/9 • 3 years and 9 months
|
Additional Information
Dr. Luis E. Fayad / Associate Professor
MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60