Trial · NCT00460265
Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer
NCT00460265, Phase 3, Completed, Amgen; results first posted 2011-06-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer. Trials, record NCT00460265. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00460265
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer
- NCT number
- NCT00460265
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 658 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Recurrent and/or Metastatic Head and Neck Cancer
- Interventions
- ARM 2, ARM 1
- First posted
- 2007-04-13
- Last updated
- 2014-03-07
- Results first posted
- 2011-06-14
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Upto 56 months | Time from randomization to death |
| Secondary | Overall Response Rate | Every 6 weeks until disease progression, up to 56 months | An objective tumor response of complete or partial response per modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 that was confirmed no less than 28 days after the criteria for response were first met. Complete response = disappearance of all target lesions and partial response = ≥30% reduction in lesion size. |
| Secondary | Duration of Response | Every 6 weeks until disease progression, up to 56 months | Time from the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) to disease progression using a modified version of the RECIST v1.0 (see protocol Appendix H). |
| Secondary | Time to Progression | Every 6 weeks until disease progression, up to 56 months | Time from randomization date to date of disease progression using a modified version of the RECIST 1.0 (see protocol Appendix H) |
| Secondary | Time to Response | Every 6 weeks until disease progression, upto 56 months | Time from randomization date to the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) using a modified version of the RECIST v1.0. |
| Secondary | Progression Free Survival | Every 6 weeks until disease progression or deaths, upto 56 months | Time from randomization date to date of disease progression using a modified version of the RECIST v1.0 or death. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Upto 56 months | Intention to treat (ITT) | months | MEDIAN |
| SECONDARY | Overall Response Rate | Every 6 weeks until disease progression, up to 56 months | The subset of subjects in the ITT analysis set with at least one baseline uni-dimensionally measurable lesion using a modified version of the RECIST v1.0 (see protocol Appendix H) | subjects | NUMBER |
| SECONDARY | Duration of Response | Every 6 weeks until disease progression, up to 56 months | Included only those subjects with a confirmed complete or partial response. | months | MEDIAN |
| SECONDARY | Time to Progression | Every 6 weeks until disease progression, up to 56 months | ITT | months | MEDIAN |
| SECONDARY | Time to Response | Every 6 weeks until disease progression, upto 56 months | Included only those subjects with a confirmed complete response or partial response. | months | MEDIAN |
| SECONDARY | Progression Free Survival | Every 6 weeks until disease progression or deaths, upto 56 months | ITT | months | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Panitumumab Plus Chemotherapy | 11.1 | 95% Confidence Interval 9.8 to 12.2 | months | |
| Overall Survival | Chemotherapy Alone | 9.0 | 95% Confidence Interval 8.1 to 11.2 | months | |
| Overall Response Rate | Panitumumab Plus Chemotherapy | 101 | subjects | ||
| Overall Response Rate | Chemotherapy Alone | 73 | subjects | ||
| Duration of Response | Panitumumab Plus Chemotherapy | 5.6 | 95% Confidence Interval 4.8 to 6.2 | months | |
| Duration of Response | Chemotherapy Alone | 5.7 | 95% Confidence Interval 4.7 to 6.2 | months | |
| Time to Progression | Panitumumab Plus Chemotherapy | 6.8 | 95% Confidence Interval 5.9 to 6.9 | months | |
| Time to Progression | Chemotherapy Alone | 5.6 | 95% Confidence Interval 5.2 to 5.8 | months | |
| Time to Response | Panitumumab Plus Chemotherapy | 1.4 | Inter-Quartile Range 1.3 to 2.5 | months | |
| Time to Response | Chemotherapy Alone | 1.5 | Inter-Quartile Range 1.3 to 2.6 | months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Panitumumab Plus Chemotherapy | 328 | |
| Overall Study | STARTED | Chemotherapy Alone | 330 | |
| Overall Study | Randomized While Alive | Panitumumab Plus Chemotherapy | 327 | |
| Overall Study | Randomized While Alive | Chemotherapy Alone | 330 | |
| Overall Study | Received Study Medication | Panitumumab Plus Chemotherapy | 325 | |
| Overall Study | Received Study Medication | Chemotherapy Alone | 325 | |
| Overall Study | COMPLETED | Panitumumab Plus Chemotherapy | 243 | |
| Overall Study | COMPLETED | Chemotherapy Alone | 241 | |
| Overall Study | NOT COMPLETED | Panitumumab Plus Chemotherapy | 85 | |
| Overall Study | NOT COMPLETED | Chemotherapy Alone | 89 |
Source ClinicalTrials.gov
Adverse events614
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 | Anaemia | Blood and lymphatic system disorders | Panitumumab Plus Chemotherapy | 132 | 325 | |
| other | Anaemia | Blood and lymphatic system disorders | Chemotherapy Alone | 126 | 325 | |
| other | Leukopenia | Blood and lymphatic system disorders | Panitumumab Plus Chemotherapy | 51 | 325 | |
| other | Leukopenia | Blood and lymphatic system disorders | Chemotherapy Alone | 49 | 325 | |
| other | Neutropenia | Blood and lymphatic system disorders | Panitumumab Plus Chemotherapy | 157 | 325 | |
| other | Neutropenia | Blood and lymphatic system disorders | Chemotherapy Alone | 140 | 325 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Panitumumab Plus Chemotherapy | 74 | 325 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Chemotherapy Alone | 74 | 325 | |
| other | Tinnitus | Ear and labyrinth disorders | Panitumumab Plus Chemotherapy | 21 | 325 | |
| other | Tinnitus | Ear and labyrinth disorders | Chemotherapy Alone | 28 | 325 |
1 to 10 of 614Source ClinicalTrials.gov
See all 614 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Panitumumab Plus Chemotherapy | ||
| Total, all-cause mortality | Chemotherapy Alone | ||
| Total, other adverse events | Panitumumab Plus Chemotherapy | 311 | 325 |
| Total, other adverse events | Chemotherapy Alone | 301 | 325 |
| Total, serious adverse events | Panitumumab Plus Chemotherapy | 157 | 325 |
| Total, serious adverse events | Chemotherapy Alone | 139 | 325 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23746666 | BACKGROUND |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Panitumumab Plus Chemotherapy vs Chemotherapy 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/NCT00460265
GET https://conductscience.org/api/trials/v1/NCT00460265/events?page=2