Trial · NCT00246012
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose Limiting Toxicities (DLTs) - Phase 1 | Up to 21 days post-first infusion from the last treated participant in Phase 1 | Safety population included all the participants who received at least 1 (partial or complete) dose of intetumumab/placebo or dacarbazine. | Participants | NUMBER |
| PRIMARY | Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 1 (Part 1) | Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose | The Pharmacokinetics (PK)-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. | Microgram per milliliter (mcg/mL) | MEAN |
| PRIMARY | Area Under the Serum Concentration Versus Time Curve (AUC) of Intetumumab - Phase 1 (Part 1) | Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose | The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | mcg*day/mL | MEAN |
| PRIMARY | Half-life of Intetumumab - Phase 1 (Part 1) | Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose | The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Days | MEAN |
| PRIMARY | Total Clearance (CL) of Intetumumab After Intravenous Administration - Phase 1 (Part 1) | Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose | The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | mL/day/kg | MEAN |
| PRIMARY | Volume of Distribution (Vz) of Intetumumab - Phase 1 (Part 1) | Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose | The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | mL/kg | MEAN |
| PRIMARY | Accumulation Ratio (R) of Intetumumab - Phase 1 (Part 1) | Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose | The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. Serum concentration data was insufficient to robustly estimate the accumulation ratio. | ||
| PRIMARY | Progression-Free Survival (PFS) - Phase 2 | From the date of randomization to date of initial documented progressive disease or death, whichever occured first, as assessed upto 6 months after last dose of study medication | The Intent-to-treat (ITT) population included all the participants who were randomly assigned to treatment. | Days | MEDIAN |
| SECONDARY | Percentage of Participants Who Achieved a Best Overall Tumor Response as Complete Response (CR) or Partial Response (PR) - Phase 2 | Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable) | The response-evaluable population included all the participants who were evaluable for response. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved CR - Phase 2 | Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable) | The response-evaluable population included all the participants who were evaluable for response. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Stable Disease (SD) - Phase 2 | Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable) | The response-evaluable population included all the participants who were evaluable for response. | Percentage of Participants | NUMBER |
| SECONDARY | Overall Survival (OS) - Phase 2 | Every 3 months until death, until lost to follow-up, until withdrawal of consent, or until the Sponsor ends the study, as assessed up to 6 months post-last dose of study medication | The ITT population included all the participants who were randomly assigned to treatment. | Days | MEDIAN |
| SECONDARY | Duration of Response - Phase 2 | From the time of initial documented response (CR or PR) to the first documented sign of progression, assessed up to 6 months post-last dose of study medication | The response-evaluable population included all the participants who were evaluable for response. The results were reported as individual participant's listings, but not statistically summarized. | ||
| SECONDARY | Time to Worsening in Eastern Cooperative Oncology Group (ECOG) Performance Status - Phase 2 | Baseline (within 7 days of first infusion of study medication), Day 1 of all 8 cycles, 3 weeks or 1 week post-last dose, 3 months and 6 months post-last dose of study medication | The ITT population included all the participants who were randomly assigned to treatment. | Days | MEDIAN |
| SECONDARY | Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 2 | Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose | The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. | mcg/mL | MEAN |
| SECONDARY | Change From Baseline in Functional Assessment of Cancer Therapy-Melanoma Subscale (FACT-MS) Score - Phase 2 | Day 1 (pre-dose) of Cycles 1, 2, 3; and final visit (3 weeks post-last dose of study medication) | The ITT population included all the participants who were randomly assigned to treatment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Brief Pain Inventory (BPI) Score - Phase 2 | Day 1 (pre-dose) of Cycles 1, 2, 3; and final visit (3 weeks post-last dose of study medication) | The ITT population included all the participants who were randomly assigned to treatment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points. | Units on a scale | MEAN |
| SECONDARY | Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 1 (Part 2) | Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose | The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Microgram per milliliter (mcg/mL) | MEAN |
| SECONDARY | Area Under the Serum Concentration Versus Time Curve (AUC) of Intetumumab - Phase 1 (Part 2) | Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose | The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | mcg*day/mL | MEAN |
| SECONDARY | Half-life of Intetumumab - Phase 1 (Part 2) | Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose | The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Days | MEAN |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT00246012/outcomes