Trial · NCT00891930
Study to Evaluate Mechanisms of Acquired Resistance to Panitumumab
NCT00891930, Phase 2, Completed, NantBioScience, Inc.; results first posted 2016-02-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate Mechanisms of Acquired Resistance to Panitumumab. Trials, record NCT00891930. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00891930
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Mechanisms of Acquired Resistance to Panitumumab
- NCT number
- NCT00891930
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 74 participants, actual
- Lead sponsor
- NantBioScience, Inc.
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Panitumumab, Ganitumab, Irinotecan
- First posted
- 2009-05-01
- Last updated
- 2024-07-17
- Other registries' IDs
- eudract:2008-004752-77
- Results first posted
- 2016-02-08
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PFS Hazard Ratio | From baseline up to 152 weeks (from baseline to the time of the second biopsy prior to entering part 2) . | KRAS mutation status changed from wild-type at baseline to mutant at time of second biopsy in part 1, as measured by the PFS hazard ratio. Hazard ratio is presented as wild-type: mutant |
| Primary | Objective Response Rate in Part 2 | From time of randomization until confirmed complete response or partial response (part 2: up to 119 weeks) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Objective Response Rate for Part 1 | from first dose of investigational product up to 152 weeks | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. |
| Secondary | Progression-Free Survival for Part 1 | from first dose of investigational product up to 152 weeks | Time from the first dose of investigational product to the first date of disease progression per the modified RECIST v1.0 or death by any cause, initiating a new line of antitumor therapy, or receiving study treatment in Part 2, whichever is earlier in Part 1. Disease progression is a \>= 20% increase in the sum of the longest diameter of the target lesions as compared to the smallest sum while on study per RECIST v1.0 |
| Secondary | Progression-Free Survival for Part 2 | 119 weeks from the start of part 2, up to a maximum duration of 152 week | Time from the start of Part 2 to the first date of disease progression per the modified RECIST v1.0 or death by any cause, initiating a new line of antitumor therapy, or receiving study treatment in Part 2, whichever is earlier. Disease progression is a \>= 20% increase in the sum of the longest diameter of the target lesions as compared to the smallest sum while on study per RECIST v1.0. |
| Secondary | Overall Survival for Part 1 | from first dose of investigational product up to 152 weeks | Time from the first dose of investigational product to death from any cause in Part 1. |
| Secondary | Overall Survival for Part 2 | from the start of Part 2 up to 119 weeks | Time from the start of Part 2 to death from any cause. |
| Secondary | Time to Response for Part 1 | from first dose of investigational product up to 152 weeks | Time from the first dose of investigational product to the date of first confirmed objective response in Part 1. An objective response is defined as a confirmed complete response or partial response per modified RECIST v1.0 criteria during the treatment period. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. |
| Secondary | Duration of Response for Part 1 | from first dose of investigational product up to 152 weeks | Time from first confirmed objective response to disease progression per modified RECIST v1.0 in Part 1. An objective response is defined as a confirmed complete response or partial response per modified RECIST v1.0 criteria during the treatment period. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR; Disease progression is a \>= 20% increase in the sum of the longest diameter of the target lesions as compared to the smallest sum while on study. |
| Secondary | Part 2 Time to Response and Duration of Response | From time of randomization until confirmed complete response or partial response (part 2: up to 119 weeks) | Time to response was defined as the time from study day 1 to the first observation of an objective response (confirmed complete response or partial response using modified Response Evaluation Criteria in Solid Tumors \[RECIST\]). Duration of response was the time from the first observation of an objective response to the subsequent time of disease progression (per modified RECIST or clinical progression, whichever came first) or death due to any cause. Objective response = a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors \[RECIST\]. Per RECIST: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | PFS Hazard Ratio | From baseline up to 152 weeks (from baseline to the time of the second biopsy prior to entering part 2) . | months | NUMBER | |
| PRIMARY | Objective Response Rate in Part 2 | From time of randomization until confirmed complete response or partial response (part 2: up to 119 weeks) | percentage of participants | NUMBER | |
| SECONDARY | Objective Response Rate for Part 1 | from first dose of investigational product up to 152 weeks | percentage of participants | NUMBER | |
| SECONDARY | Progression-Free Survival for Part 1 | from first dose of investigational product up to 152 weeks | months | MEDIAN | |
| SECONDARY | Progression-Free Survival for Part 2 | 119 weeks from the start of part 2, up to a maximum duration of 152 week | months | MEDIAN | |
| SECONDARY | Overall Survival for Part 1 | from first dose of investigational product up to 152 weeks | months | MEDIAN | |
| SECONDARY | Overall Survival for Part 2 | from the start of Part 2 up to 119 weeks | months | MEDIAN | |
| SECONDARY | Time to Response for Part 1 | from first dose of investigational product up to 152 weeks | months | MEAN | |
| SECONDARY | Duration of Response for Part 1 | from first dose of investigational product up to 152 weeks | months | MEDIAN | |
| SECONDARY | Part 2 Time to Response and Duration of Response | From time of randomization until confirmed complete response or partial response (part 2: up to 119 weeks) | Due to no subjects having complete or partial responses, these Secondary Outcomes were not summarized. |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| PFS Hazard Ratio | Part 1 | 0.365 | 95% Confidence Interval 0.164 to 0.808 | months | |
| Objective Response Rate in Part 2 | Part 2 | 0.00 | 95% Confidence Interval 0.00 to 9.74 | percentage of participants | |
| Objective Response Rate for Part 1 | Part 1 | 21.62 | 95% Confidence Interval 12.89 to 32.72 | percentage of participants | |
| Progression-Free Survival for Part 1 | Panitumumab | 4.6 | 95% Confidence Interval 3.7 to 6.9 | months | |
| Progression-Free Survival for Part 2 | Panitumumab | 1.7 | 95% Confidence Interval 1.6 to 1.8 | months | |
| Overall Survival for Part 1 | Panitumumab | 11.6 | 95% Confidence Interval 7.8 to 12.9 | months | |
| Overall Survival for Part 2 | Panitumumab | 7.6 | 95% Confidence Interval 5.6 to 12.3 | months | |
| Time to Response for Part 1 | Panitumumab | 2.0 | Standard Deviation 0.4 | months | |
| Duration of Response for Part 1 | Panitumumab | 7.7 | 95% Confidence Interval 6.7 to 9.1 | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 Panitumumab + Irinotecan | STARTED | Overall Study | 74 | |
| Part 1 Panitumumab + Irinotecan | COMPLETED | Overall Study | 5 | |
| Part 1 Panitumumab + Irinotecan | NOT COMPLETED | Overall Study | 69 | |
| Part 2 Panitumumab + AMG479 | STARTED | Overall Study | 36 | |
| Part 2 Panitumumab + AMG479 | COMPLETED | Overall Study | 5 | |
| Part 2 Panitumumab + AMG479 | NOT COMPLETED | Overall Study | 31 |
Source ClinicalTrials.gov
Adverse events226
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 | Diarrhoea | Gastrointestinal disorders | Part 1 Panitumumab + Irinotecan | 55 | 74 | |
| other | Diarrhoea | Gastrointestinal disorders | Part 2 Panitumumab + AMG479 | 8 | 36 | |
| other | Asthenia | General disorders | Part 1 Panitumumab + Irinotecan | 41 | 74 | |
| other | Asthenia | General disorders | Part 2 Panitumumab + AMG479 | 12 | 36 | |
| other | Rash | Skin and subcutaneous tissue disorders | Part 1 Panitumumab + Irinotecan | 39 | 74 | |
| other | Rash | Skin and subcutaneous tissue disorders | Part 2 Panitumumab + AMG479 | 15 | 36 | |
| other | Nausea | Gastrointestinal disorders | Part 1 Panitumumab + Irinotecan | 38 | 74 | |
| other | Nausea | Gastrointestinal disorders | Part 2 Panitumumab + AMG479 | 10 | 36 | |
| other | Decreased Appetite | Metabolism and nutrition disorders | Part 1 Panitumumab + Irinotecan | 28 | 74 | |
| other | Decreased Appetite | Metabolism and nutrition disorders | Part 2 Panitumumab + AMG479 | 5 | 36 |
1 to 10 of 226Source ClinicalTrials.gov
See all 226 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1 Panitumumab + Irinotecan | 66 | 74 |
| Total, all-cause mortality | Part 2 Panitumumab + AMG479 | 30 | 36 |
| Total, other adverse events | Part 1 Panitumumab + Irinotecan | 74 | 74 |
| Total, other adverse events | Part 2 Panitumumab + AMG479 | 35 | 36 |
| Total, serious adverse events | Part 1 Panitumumab + Irinotecan | 26 | 74 |
| Total, serious adverse events | Part 2 Panitumumab + AMG479 | 8 | 36 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28945848 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Part 1 Panitumumab + Irinotecan vs Part 2 Panitumumab + AMG479: deaths from any cause | Trial comparisons |
| Part 1 Panitumumab + Irinotecan vs Part 2 Panitumumab + AMG479: serious adverse events | 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/NCT00891930
GET https://conductscience.org/api/trials/v1/NCT00891930/events?page=2