Trial · NCT01911273
A Study To Evaluate The Efficacy And Safety of The Investigational Drug PF-03446962 (A Monoclonal Antibody With Antiangiogenic Features) In Combination With Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients Affected By Recurrent Liver Cancer
NCT01911273, Phase 2, Terminated, Pfizer; results first posted 2015-06-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study To Evaluate The Efficacy And Safety of The Investigational Drug PF-03446962 (A Monoclonal Antibody With Antiangiogenic Features) In Combination With Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients Affected By Recurrent Liver Cancer. Trials, record NCT01911273. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01911273
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study To Evaluate The Efficacy And Safety of The Investigational Drug PF-03446962 (A Monoclonal Antibody With Antiangiogenic Features) In Combination With Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients Affected By Recurrent Liver Cancer
- NCT number
- NCT01911273
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Carcinoma, Hepatocellular
- Interventions
- PF-03446962, Best Supportive Care, Placebo, Best Supportive Care
- First posted
- 2013-07-30
- Last updated
- 2015-10-28
- Other registries' IDs
- eudract:2013-001426-26
- Results first posted
- 2015-06-29
- Limitations and caveats
- This study was prematurely terminated due to a Sponsor decision not to pursue the clinical development of PF-03446962 as monotherapy in second-line hepatocellular carcinoma.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | OS was the duration from date of randomization to date of death due to any cause. For participants who are alive, overall survival was censored at the last contact. Death was determined from adverse event (AE) data where outcome was death or from follow-up contact data where the participant current status was death. |
| Secondary | Time to Tumor Progression (TTP) | Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization. | TTP was defined as the time from first randomization to date of first documentation of objective tumor progression. If tumor progression data included more than (\>) 1 date, the first date was to be used. TTP (in months) was calculated as first event date or last known progression-free date minus the first randomization date plus 1 divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease per Response Evaluation Criteria in Solid Tumors \[RECIST\] version 1.1). |
| Secondary | Progression-Free Survival (PFS) | Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization. | PFS was defined as the time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. If tumor progression data included \>1 date, the first date was to be used. PFS (in months) was calculated as first event date minus first randomization date plus 1 divided by 30.4. |
| 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. | ORR was defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1, relative to all randomized participants. CR were those that persisted on repeat imaging study more than or equal to (\>=) 4 weeks after initial documentation of response. PR was defined as \>=30% decrease in the sum of diameters of target lesions and non CR/non PD to non-target lesions. Participants who did not have on study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were to be counted as non-responders in the assessment of ORR. A participant who initially met the criteria for a PR and then subsequently became a confirmed CR, was to be assigned a best response of CR. |
| 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 | DR was defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included \>1 date, the first date was to be used. DR (in months) was calculated as the end date for DR minus date of first CR or PR that was subsequently confirmed plus 1 divided by 30.4. CR was defined as disappearance of all target lesions and non-target, if any. PR was defined as \>=30% decrease in the sum of diameters of target lesions and non CR/non PD to non-target lesions. |
| 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 | DCR was defined as the proportion of participants with confirmed CR or confirmed PR or a best response of stable disease (SD) \>=16 weeks according to RECIST, relative to all randomized participants. CR was defined as disappearance of all target lesions. PR was defined as \>=30% decrease in the sum of diameters of target lesions and non CR/non PD to non-target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. |
| 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. | Patient reported outcomes (PROs) were assessed using the FACT-Hep. The FACT-Hep included the FACT-general (FACT-G) and a hepatobiliary module, it consisted of the 27-item FACT-G, which assessed generic health-related quality of life (HRQoL) concerns, and the 18-item hepatobiliary subscale (HS), which assessed disease-specific issues. The questionnaire used a 5 point Likert scale from '0' "not at all" to '4' "very much" regarding how much each item was present in the last 7 days; lower score indicated severer symptom. Eight of the items (lack of energy, pain, weight loss, back pain, fatigue, stomach pain/discomfort, nausea, and jaundice) made up the Fact Hepatobiliary Symptom Index (FHSI 8) were considered to be symptoms specific to hepatobiliary cancer. |
| Secondary | Maximum Serum Concentration (Cmax) | 1 hour (after start of infusion) on Day1 of Cycles 1, 2, 4, 6, and 8 | |
| Secondary | Trough Serum Concentration of PF-03446962 (Ctrough) | 0 hour (predose) on Day 1 of Cycles 1, 2, 4, 6, and 8 | |
| Secondary | Number of Participants With Human Anti-Human Antibodies (HAHA) | Cycle 1, 2, 4, 6, 8 Day 1 at 0 hour (pre-dose) |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Tumor Progression (TTP) | PF-03446962 Plus BSC | NA | 95% Confidence Interval NA to NA | Months | |
| Time to Tumor Progression (TTP) | BSC Alone | NA | 95% Confidence Interval NA to NA | Months | |
| Overall Survival (OS) | PF-03446962 Plus BSC | NA | 95% Confidence Interval NA to NA | Months | |
| Overall Survival (OS) | BSC Alone | NA | 95% Confidence Interval NA to NA | Months | |
| Progression-Free Survival (PFS) | PF-03446962 Plus BSC | NA | 95% Confidence Interval NA to NA | Months | |
| Progression-Free Survival (PFS) | BSC Alone | NA | 95% Confidence Interval NA to NA | Months | |
| Objective Response Rate (ORR) - Percentage of Participants With Objective Response | PF-03446962 Plus BSC | NA | Percentage of Participants | ||
| Objective Response Rate (ORR) - Percentage of Participants With Objective Response | BSC Alone | NA | Percentage of Participants | ||
| Percentage of Participants With Disease Control Rate (DCR) at 16 Weeks | PF-03446962 Plus BSC | NA | 95% Confidence Interval NA to NA | Percentage of Participants | |
| Percentage of Participants With Disease Control Rate (DCR) at 16 Weeks | BSC Alone | NA | 95% Confidence Interval NA to NA | Percentage of Participants |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PF-03446962 Plus BSC | 1 | |
| Overall Study | STARTED | BSC Alone | 2 | |
| Overall Study | COMPLETED | PF-03446962 Plus BSC | 0 | |
| Overall Study | COMPLETED | BSC Alone | 0 | |
| Overall Study | NOT COMPLETED | PF-03446962 Plus BSC | 1 | |
| Overall Study | NOT COMPLETED | BSC Alone | 2 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gastroenteritis | Infections and infestations | PF-03446962 Plus BSC | 1 | 1 | 1 |
| other | Gastroenteritis | Infections and infestations | BSC Alone | 0 | 2 | 0 |
| other | Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | PF-03446962 Plus BSC | 1 | 1 | 2 |
| other | Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | BSC Alone | 0 | 2 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-03446962 Plus BSC | ||
| Total, all-cause mortality | BSC Alone | ||
| Total, other adverse events | PF-03446962 Plus BSC | 1 | 1 |
| Total, other adverse events | BSC Alone | 0 | 2 |
| Total, serious adverse events | PF-03446962 Plus BSC | 0 | 1 |
| Total, serious adverse events | BSC Alone | 0 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| PF-03446962 Plus BSC vs BSC Alone: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01911273
GET https://conductscience.org/api/trials/v1/NCT01911273/registered