TriangleNCT01808534 · STUDY IN CONTEXT
Palifosfamide in Treating Patients With Recurrent Germ Cell Tumors
Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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.
The 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.
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.
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer-recurrent-703d57c3
- nct id
- NCT01808534
- trial label
- Palifosfamide in Treating Patients With Recurrent Germ Cell Tumors
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 5
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer-recurrent-703d57c3
- nct id
- NCT01808534
- outcome key
- om-0000
- source section id
- NCT01808534-om-0000
- source outcome index
- 0
- endpoint
- Overall Response Rate (Defined as Partial Response or Complete Response)
- endpoint definition
- 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.
- time origin
- Up to 2 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who enrolled and received treatment with at least one post baseline assessment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer-recurrent-703d57c3
- nct id
- NCT01808534
- outcome key
- om-0001
- source section id
- NCT01808534-om-0001
- source outcome index
- 1
- endpoint
- Duration of Remission in Patients Who Achieve a Partial or Complete Response
- endpoint definition
- The 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.
- time origin
- Up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer-recurrent-703d57c3
- nct id
- NCT01808534
- outcome key
- om-0002
- source section id
- NCT01808534-om-0002
- source outcome index
- 2
- endpoint
- Progression Free Survival (PFS)
- endpoint definition
- 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.
- time origin
- Up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who enrolled and received treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer-recurrent-703d57c3
- nct id
- NCT01808534
- outcome key
- om-0003
- source section id
- NCT01808534-om-0003
- source outcome index
- 3
- endpoint
- Overall Survival
- endpoint definition
- 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.
- time origin
- Up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who enrolled and received treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer-recurrent-703d57c3
- nct id
- NCT01808534
- outcome key
- om-0004
- source section id
- NCT01808534-om-0004
- source outcome index
- 4
- endpoint
- Treatment Related Adverse Events Grade 3 or Higher
- endpoint definition
- 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.
- time origin
- Up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who enrolled and received treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer-recurrent-703d57c3
- nct id
- NCT01808534
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Palifosfamide)
- regimen
- 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.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01808534-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer-recurrent-703d57c3
- nct id
- NCT01808534
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (Palifosfamide)
- regimen
- 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.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01808534-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer-recurrent-703d57c3
- nct id
- NCT01808534
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (Palifosfamide)
- regimen
- 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.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01808534-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer-recurrent-703d57c3
- nct id
- NCT01808534
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment (Palifosfamide)
- regimen
- 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.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01808534-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer-recurrent-703d57c3
- nct id
- NCT01808534
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Treatment (Palifosfamide)
- regimen
- 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.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01808534-om-0004#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer-recurrent-703d57c3
- nct id
- NCT01808534
- harm key
- EG000
- source section id
- NCT01808534-ae
- event group key
- EG000
- event group label
- Treatment (Palifosfamide)
- serious affected
- 2
- serious at risk
- 5
- other affected
- 4
- other at risk
- 5
- frequency threshold
- 5
- collection period
- Up to 2 years
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice