Trial Outcomes & Findings for Palifosfamide in Treating Patients With Recurrent Germ Cell Tumors (NCT NCT01808534)
NCT ID: NCT01808534
Last Updated: 2015-07-02
Results Overview
The percent of patients who were shown as having a partial remission or better based on definitions of response in RECIST 1.1. At least a 30% decrease in the sum of the diameters of target lesions, in reference to baseline sum diameters, needs to be confirmed to be considered as partial response or better. Note: There were no patients with a partial or complete response.
TERMINATED
PHASE2
5 participants
Up to 2 years
2015-07-02
Participant Flow
This protocol was based on a two stage design, getting 12 patients at the first stage and 8 more if at least one CR or PR was observed in the first 12. Due to low accrual, the study was stopped at 5 patients for this study.
Participant milestones
| Measure |
Treatment (Palifosfamide)
Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Treatment (Palifosfamide)
Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Disease progression
|
3
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Palifosfamide in Treating Patients With Recurrent Germ Cell Tumors
Baseline characteristics by cohort
| Measure |
Treatment (Palifosfamide)
n=5 Participants
Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
36.6 years
STANDARD_DEVIATION 13.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All patients who enrolled and received treatment with at least one post baseline assessment.
The percent of patients who were shown as having a partial remission or better based on definitions of response in RECIST 1.1. At least a 30% decrease in the sum of the diameters of target lesions, in reference to baseline sum diameters, needs to be confirmed to be considered as partial response or better. Note: There were no patients with a partial or complete response.
Outcome measures
| Measure |
Treatment (Palifosfamide)
n=5 Participants
Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Response Rate (Defined as Partial Response or Complete Response)
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsThe duration of remission is from the time of confirmed partial or complete response until progression or death. Patients continuing in remission at the end of the study will be treated as censored. Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Note: There were no patients who achieved partial or complete response.
Outcome measures
| Measure |
Treatment (Palifosfamide)
n=5 Participants
Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Duration of Remission in Patients Who Achieve a Partial or Complete Response
|
0 months
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All patients who enrolled and received treatment.
Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Time until progression, death or last evaluation will be calculated. If a patient did not progress or die, they will be censored at their last evaluation in the analysis.
Outcome measures
| Measure |
Treatment (Palifosfamide)
n=5 Participants
Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression Free Survival (PFS)
|
0.69 months
Interval 0.07 to 6.18
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All patients who enrolled and received treatment.
Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis at their last known alive date.
Outcome measures
| Measure |
Treatment (Palifosfamide)
n=5 Participants
Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
0.95 months
Interval 0.56 to 15.63
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All patients who enrolled and received treatment.
Number of unique patients who had a treatment related (possible, probable or definite) adverse event that was graded 3 or greater according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
Outcome measures
| Measure |
Treatment (Palifosfamide)
n=5 Participants
Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Treatment Related Adverse Events Grade 3 or Higher
|
1 participants
|
Adverse Events
Treatment (Palifosfamide)
Serious adverse events
| Measure |
Treatment (Palifosfamide)
n=5 participants at risk
Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
20.0%
1/5 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
20.0%
1/5 • Up to 2 years
|
Other adverse events
| Measure |
Treatment (Palifosfamide)
n=5 participants at risk
Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
60.0%
3/5 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • Up to 2 years
|
|
General disorders
Edema limbs
|
20.0%
1/5 • Up to 2 years
|
|
General disorders
Fatigue
|
80.0%
4/5 • Up to 2 years
|
|
General disorders
Non-cardiac chest pain
|
20.0%
1/5 • Up to 2 years
|
|
General disorders
Pain
|
20.0%
1/5 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
2/5 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.0%
2/5 • Up to 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
1/5 • Up to 2 years
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Up to 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
20.0%
1/5 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
60.0%
3/5 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.0%
1/5 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
20.0%
1/5 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • Up to 2 years
|
|
Vascular disorders
Thromboembolic event
|
20.0%
1/5 • Up to 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place