Trial · NCT01911273
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Time to Tumor Progression (TTP) | Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization. | FAS included all randomized participants regardless of what treatment, if any, was received. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) | From first randomization to date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization | Full analysis set (FAS) included all randomized participants regardless of what treatment, if any, was received. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization. | FAS included all randomized participants regardless of what treatment, if any, was received. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) - Percentage of Participants With Objective Response | Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization. | FAS included all randomized participants regardless of what treatment, if any, was received. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DR) | From first randomization to date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization | Subgroup of participants with objective response. Since objective response was not assessed in any of the participants, ideally the number of participants analyzed field should be 0 and the reason was insufficient data available to conduct adequate analysis due to premature termination of the study. | ||
| SECONDARY | Percentage of Participants With Disease Control Rate (DCR) at 16 Weeks | From first randomization to date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization | FAS included all randomized participants regardless of what treatment, if any, was received. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Functional Assessment of Cancer Therapy-Hepatobiliary Questionnaire (FACT-Hep) | Screening, Cycle 1 Day1,8; Cycle >=2 Day1; End of treatment, survival follow-up up to 24 months after last participant randomization. | FAS included all randomized participants regardless of what treatment, if any, was received. | Units on scale | MEAN |
| SECONDARY | Maximum Serum Concentration (Cmax) | 1 hour (after start of infusion) on Day1 of Cycles 1, 2, 4, 6, and 8 | The pharmacokinetic (PK) concentration set consisted of all participants who were treated and had at least one concentration on at least 1 day of PK assessment. | microgram per milliliter (mcg/mL) | GEOMETRIC_MEAN |
| SECONDARY | Trough Serum Concentration of PF-03446962 (Ctrough) | 0 hour (predose) on Day 1 of Cycles 1, 2, 4, 6, and 8 | The PK concentration set consisted of all participants who were treated and had at least one concentration on at least 1 day of PK assessment. | mcg/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Human Anti-Human Antibodies (HAHA) | Cycle 1, 2, 4, 6, 8 Day 1 at 0 hour (pre-dose) | The immunogenicity assessment consisted of all participants who had at least 1 sample on at least 1 day of immunogenicity assessment. | Participants | NUMBER |
| SECONDARY | Presence of Sensitivity Signature | Cycle 1 Day 1 (before infusion), Cycle 4 Day 1 (before infusion), at disease progression/participant withdrawal. | FAS included all randomized participants regardless of what treatment, if any, was received. | ||
| SECONDARY | Ratio to Baseline of Serum Circulating Protein Concentration | Cycle 1 Day 1 (before infusion), Cycle 4 Day 1 (before infusion), at disease progression/participant withdrawal. | FAS included all randomized participants regardless of what treatment, if any, was received. | Percentage | NUMBER |
| SECONDARY | Observed Serum Concentration of Circulating Protein | Cycle 1 Day 1 (before infusion), Cycle 4 Day 1 (before infusion), at disease progression/participant withdrawal. | FAS included all randomized participants regardless of what treatment, if any, was received. | mcg/mL | NUMBER |
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/NCT01911273/outcomes