Trial · NCT01137006
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of IMC-20D7S | Baseline to toxicity [up to end of Cycle 1 (4 or 6-week cycles)] | Participants who completed Cycle 1 of treatment. | mg/kg q2w | NUMBER |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Baseline through 30 days post last dose (up to 31 weeks) | Participants who received any amount of IMC-20D7S . | participants | NUMBER |
| SECONDARY | IMC-20D7S Pharmacokinetics (PK): Maximum Concentration (Cmax) | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 hours (h) post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | No participant was analyzed. | ||
| SECONDARY | IMC-20D7S PK: Minimal Concentration (Cmin) | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | No participant was analyzed. | ||
| SECONDARY | IMC-20D7S PK: Half-life (t½) | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | No participant was analyzed. | ||
| SECONDARY | IMC-20D7S PK: Clearance (Cl) | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | No participant was analyzed. | ||
| SECONDARY | IMC-20D7S PK: Area Under the Concentration Versus Time Curve (AUC) | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | No participant was analyzed. | ||
| SECONDARY | IMC-20D7S PK: Volume of Distribution (Vd) at Steady State | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | No participant was analyzed. | ||
| SECONDARY | Number of Participants Who Develop Antibodies Against IMC-20D7S (Immunogenicity) | Prior to the first and second infusion in each cycle up to Cycle 7 (4- and 6-week cycles) | No participant was analyzed. | ||
| SECONDARY | Progression-Free Survival (PFS) | First dose to disease progression or death (up to 27 weeks) | Participants who went beyond their first disease assessment and completed at least one treatment beyond Week 1 of treatment Cycle 3. | participants | NUMBER |
| SECONDARY | Recommend Doses for Phase 2/3 Studies Based on MTD | Baseline to toxicity [up to end of Cycle 1 (4-or 6-week cycles)] | No participant was analyzed. |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01137006/outcomes