Trial · NCT00780000
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective tumor response rate (either RECIST or WHO complete response, partial response or minor response) confirmed by CT and MRI as the preferred methods for tumor assessments and Chest x-ray is acceptable for pulmonary lesions | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) | (all patients were off study by June 2008) |
| Secondary | Adverse Events assessed according to the NCI CTCAE (v 3.0) grading system | Within 28 days prior to the start of treatment, and for 167 days | (all patients were off study by June 2008) |
| Secondary | Laboratory tests assessed according to the NCI CTCAE (v 3.0) grading system | Within 10 days prior to Cycle 1/1st infusion; within 48 hours of infusion (Cycle 1/Weeks 2/3/4 and Cycle 2+/Week3), or within 72 hours prior to infusion (Cycle 2+/Week 1) | |
| Secondary | Vital signs | Within 28 days prior to the start of treatment, Day1 of Weeks 1, 2, and 3 of Cycle 1 (4 weeks long), and prior to each 4-week cycle starting with Cycle 2, for 167 days | (all patients were off study by June 2008) |
| Secondary | Karnofsky Performance Status | Within 28 days prior to the start of treatment, prior to each 4-week cycle starting with Cycle 2, for 167 days | (all patients were off study by June 2008) |
| Secondary | Ocular testing | Within 28 days prior to the start of treatment, Cycle 1/Day 10 (3 days +/- 1 day following the 2nd infusion in the first cycle of therapy), prior to Cycle 2, if clinically indicated thereafter, for 167 days | (all patients were off study by June 2008) |
| Secondary | Kaplan-Meier estimate of time to progression | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) | (all patients were off study by June 2008) |
| Secondary | Time to progression on the patient's prior cytotoxic chemotherapy compared to the patient's time to progression on alvespimycin | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) | (all patients were off study by June 2008) |
| Secondary | Kaplan-Meier estimate of progression-free survival | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) | (all patients were off study by June 2008) |
| Secondary | Kaplan-Meier estimate of time to response | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) | (all patients were off study by June 2008) |
| Secondary | Kaplan-Meier estimate of duration of response | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) | (all patients were off study by June 2008) |
| Secondary | Kaplan-Meier estimate of time to treatment failure | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) | (all patients were off study by June 2008) |
| Secondary | Kaplan-Meier estimate of overall survival | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) | (all patients were off study by June 2008) |
| Secondary | Changes in tumor markers | Within 28 days prior to the start of treatment, Prior to each 4-week cycle starting with Cycle 2, for 167 days | |
| Secondary | Histopathological and molecular profile of responding and non-responding patients using paraffin-embedded surgical specimens | Specimens were obtained within 28 days prior to the start of treatment |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT00780000/registered