Trial · NCT03719690
Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy
NCT03719690, Phase 2, Completed, Kura Oncology, Inc.; results first posted 2024-06-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy. Trials, record NCT03719690. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03719690
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy
- NCT number
- NCT03719690
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 296 participants, actual
- Lead sponsor
- Kura Oncology, Inc.
- Conditions
- HRAS Gene Mutation, HNSCC
- Interventions
- Tipifarnib, HRAS Detection Assay
- First posted
- 2018-10-25
- Last updated
- 2024-06-21
- Results first posted
- 2024-06-21
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) in High Variable Allele Frequency (VAF) Population, as Assessed by Independent Review Facility (IRF) | Up to approximately 28 months | ORR was defined as the percentage of participants who experienced a best overall response (BOR) of complete response (CR; disappearance of all target lesions) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by IRF. 95% confidence interval (CI) was calculated by the exact binomial (Clopper-Pearson) method. |
| Secondary | ORR in All VAF Population, as Assessed by IRF | Up to approximately 28 months | ORR was defined as the percentage of participants who experienced a BOR of CR or PR and was assessed using RECIST v1.1 by IRF. 95% CI was calculated by the exact binomial (Clopper-Pearson) method. |
| Secondary | Duration of Response (DoR) in High VAF Population, as Assessed by IRF | Up to approximately 28 months | DoR was defined as the time from the date of first response (CR or PR \[whichever occurred first\]) to the date of progression of disease or death of any cause, whichever occurred first, in participants with a confirmed CR or PR and was assessed using RECIST v1.1 by IRF. Median was calculated using the Kaplan-Meier method. 95% CI was based on Brookmeyer and Crowley method with log-log transformation. |
| Secondary | DoR in All VAF Population, as Assessed by IRF | Up to approximately 28 months | DoR was defined as the time from the date of first response (CR or PR \[whichever occurred first\]) to the date of progression of disease or death of any cause, whichever occurred first, in participants with a confirmed CR or PR and was assessed using RECIST v1.1 by IRF. Median was calculated using the Kaplan-Meier method. 95% CI was based on Brookmeyer and Crowley method with log-log transformation. |
| Secondary | Progression Free Survival (PFS) in High VAF Population, as Assessed by IRF | Up to approximately 28 months | PFS was defined as months from the first dose of the study drug to the first documented progressive disease (PD, appearance of one or more new lesions or at least a 20% increase in the sum of the diameters of target lesions) or death, whichever came first and was assessed using RECIST v1.1 by IRF. Median was calculated using the Kaplan-Meier method. 95% CI was based on Brookmeyer and Crowley method with log-log transformation. |
| Secondary | PFS in All VAF Population, as Assessed by IRF | Up to 28 approximately months | PFS was defined as months from the first dose of the study drug to the first documented PD or death, whichever came first and was assessed using RECIST v1.1 by IRF. Median was calculated using the Kaplan-Meier method. 95% CI was based on Brookmeyer and Crowley method with log-log transformation. |
| Secondary | PFS Rate in High VAF Population, as Assessed by IRF | 6 months and 9 months | PFS rate was defined as the percentage of participants who had not experienced documented PD or death, whichever came first and was assessed using RECIST v1.1 by IRF at 6 and 9 month timepoints. Percentage of participants was calculated using the Kaplan-Meier method. 95% CI was calculated using normal approximation to the log transformed cumulative hazard rate |
| Secondary | PFS Rate in All VAF Population, as Assessed by IRF | 6 months and 9 months | PFS rate was defined as the percentage of participants who had not experienced documented PD or death, whichever came first and was assessed using RECIST v1.1 by IRF at 6 and 9 month timepoints. Percentage of participants was calculated using the Kaplan-Meier method. 95% CI was calculated using normal approximation to the log transformed cumulative hazard rate. |
| Secondary | Overall Survival (OS) in High VAF Population | Up to approximately 28 months | OS was defined as months from first dose date until death from any cause. Median was calculated using the Kaplan-Meier method. 95% CI was based on Brookmeyer and Crowley method with log-log transformation. |
| Secondary | OS in All VAF Population | Up to approximately 28 months | OS was defined as months from first dose date until death from any cause. Median was calculated using the Kaplan-Meier method. 95% CI was based on Brookmeyer and Crowley method with log-log transformation. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) in High Variable Allele Frequency (VAF) Population, as Assessed by Independent Review Facility (IRF) | Up to approximately 28 months | mITT Analysis Set: consisted of all participants who received at least one dose of tipifarnib. Analysis was pre-specified for participants with high VAF only. Data collection and analysis of ORR for participants in the Observational SEQ-HN Cohort was not pre-specified. | percentage of participants | NUMBER |
| SECONDARY | ORR in All VAF Population, as Assessed by IRF | Up to approximately 28 months | mITT Analysis Set: consisted of all participants who received at least one dose of tipifarnib. Analysis was pre-specified for all VAF participants. Data collection and analysis of ORR for participants in the Observational SEQ-HN Cohort was not pre-specified. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DoR) in High VAF Population, as Assessed by IRF | Up to approximately 28 months | mITT Analysis Set: consisted of all participants who received at least one dose of tipifarnib. Analysis was pre-specified for participants with high VAF and available data only. Data collection and analysis of DoR for participants in the Observational SEQ-HN Cohort was not pre-specified. | months | MEDIAN |
| SECONDARY | DoR in All VAF Population, as Assessed by IRF | Up to approximately 28 months | mITT Analysis Set: consisted of all participants who received at least one dose of tipifarnib. Analysis was pre-specified for all VAF participants with available data. Data collection and analysis of DoR for participants in the Observational SEQ-HN Cohort was not pre-specified. | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) in High VAF Population, as Assessed by IRF | Up to approximately 28 months | mITT Analysis Set: consisted of all participants who received at least one dose of tipifarnib. Analysis was pre-specified for participants with high VAF and available data only. Data collection and analysis of PFS for participants in the Observational SEQ-HN Cohort was not pre-specified. | months | MEDIAN |
| SECONDARY | PFS in All VAF Population, as Assessed by IRF | Up to 28 approximately months | mITT Analysis Set: consisted of all participants who received at least one dose of tipifarnib. Analysis was pre-specified for all VAF participants with available data. Data collection and analysis of PFS for participants in the Observational SEQ-HN Cohort was not pre-specified. | months | MEDIAN |
| SECONDARY | PFS Rate in High VAF Population, as Assessed by IRF | 6 months and 9 months | mITT Analysis Set: consisted of all participants who received at least one dose of tipifarnib. Analysis was pre-specified for participants with high VAF and available data only. Data collection and analysis of PFS for participants in the Observational SEQ-HN Cohort was not pre-specified. | percentage of participants | NUMBER |
| SECONDARY | PFS Rate in All VAF Population, as Assessed by IRF | 6 months and 9 months | mITT Analysis Set: consisted of all participants who received at least one dose of tipifarnib. Analysis was pre-specified for all VAF participants and available data. Data collection and analysis of PFS for participants in the Observational SEQ-HN Cohort was not pre-specified. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) in High VAF Population | Up to approximately 28 months | mITT Analysis Set: consisted of all participants who received at least one dose of tipifarnib. Analysis was pre-specified for participants with high VAF only. Data collection and analysis of OS for participants in the Observational SEQ-HN Cohort was not pre-specified. | months | MEDIAN |
| SECONDARY | OS in All VAF Population | Up to approximately 28 months | mITT Analysis Set: consisted of all participants who received at least one dose of tipifarnib. Analysis was pre-specified for all VAF participants. Data collection and analysis of OS for participants in the Observational SEQ-HN Cohort was not pre-specified. | months | MEDIAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) in High Variable Allele Frequency (VAF) Population, as Assessed by Independent Review Facility (IRF) | Tipifarnib Treatment Cohort: AIM-HN | 20.0 | 95% Confidence Interval 10.03 to 33.72 | percentage of participants | |
| ORR in All VAF Population, as Assessed by IRF | Tipifarnib Treatment Cohort: AIM-HN | 18.6 | 95% Confidence Interval 9.69 to 30.91 | percentage of participants | |
| Duration of Response (DoR) in High VAF Population, as Assessed by IRF | Tipifarnib Treatment Cohort: AIM-HN | 6.51 | 95% Confidence Interval 3.877 to NA | months | |
| DoR in All VAF Population, as Assessed by IRF | Tipifarnib Treatment Cohort: AIM-HN | 6.51 | 95% Confidence Interval 3.877 to NA | months | |
| Progression Free Survival (PFS) in High VAF Population, as Assessed by IRF | Tipifarnib Treatment Cohort: AIM-HN | 2.60 | 95% Confidence Interval 1.873 to 4.402 | months | |
| PFS in All VAF Population, as Assessed by IRF | Tipifarnib Treatment Cohort: AIM-HN | 2.23 | 95% Confidence Interval 1.873 to 3.548 | months | |
| PFS Rate in High VAF Population, as Assessed by IRF | Tipifarnib Treatment Cohort: AIM-HN | 6 months | 29 | 95% Confidence Interval 16.2 to 42.9 | percentage of participants |
| PFS Rate in High VAF Population, as Assessed by IRF | Tipifarnib Treatment Cohort: AIM-HN | 9 months | 20 | 95% Confidence Interval 8.9 to 33.6 | percentage of participants |
| PFS Rate in All VAF Population, as Assessed by IRF | Tipifarnib Treatment Cohort: AIM-HN | 6 months | 26 | 95% Confidence Interval 14.9 to 38.4 | percentage of participants |
| PFS Rate in All VAF Population, as Assessed by IRF | Tipifarnib Treatment Cohort: AIM-HN | 9 months | 18 | 95% Confidence Interval 8.9 to 30.8 | percentage of participants |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tipifarnib Treatment Cohort: AIM-HN | 59 | |
| Overall Study | STARTED | Observational Cohort: SEQ-HN | 237 | |
| Overall Study | Safety Analysis Set (SAS) | Tipifarnib Treatment Cohort: AIM-HN | 59 | |
| Overall Study | Safety Analysis Set (SAS) | Observational Cohort: SEQ-HN | 0 | |
| Overall Study | Modified Intent-to-Treat Analysis Set (mITT) | Tipifarnib Treatment Cohort: AIM-HN | 59 | |
| Overall Study | Modified Intent-to-Treat Analysis Set (mITT) | Observational Cohort: SEQ-HN | 0 | |
| Overall Study | COMPLETED | Tipifarnib Treatment Cohort: AIM-HN | 0 | |
| Overall Study | COMPLETED | Observational Cohort: SEQ-HN | 0 | |
| Overall Study | NOT COMPLETED | Tipifarnib Treatment Cohort: AIM-HN | 59 | |
| Overall Study | NOT COMPLETED | Observational Cohort: SEQ-HN | 237 |
Source ClinicalTrials.gov
Adverse events184
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 | Hypertension | Vascular disorders | Tipifarnib Treatment Cohort: AIM-HN | 5 | 59 | |
| other | Hypertension | Vascular disorders | Observational Cohort: SEQ-HN | 0 | ||
| other | Fatigue | General disorders | Tipifarnib Treatment Cohort: AIM-HN | 19 | 59 | |
| other | Fatigue | General disorders | Observational Cohort: SEQ-HN | 0 | ||
| other | Asthenia | General disorders | Tipifarnib Treatment Cohort: AIM-HN | 6 | 59 | |
| other | Asthenia | General disorders | Observational Cohort: SEQ-HN | 0 | ||
| other | Mucosal inflammation | General disorders | Tipifarnib Treatment Cohort: AIM-HN | 5 | 59 | |
| other | Mucosal inflammation | General disorders | Observational Cohort: SEQ-HN | 0 | ||
| other | Pyrexia | General disorders | Tipifarnib Treatment Cohort: AIM-HN | 4 | 59 | |
| other | Pyrexia | General disorders | Observational Cohort: SEQ-HN | 0 |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tipifarnib Treatment Cohort: AIM-HN | 41 | 59 |
| Total, all-cause mortality | Observational Cohort: SEQ-HN | 149 | 237 |
| Total, other adverse events | Tipifarnib Treatment Cohort: AIM-HN | 56 | 59 |
| Total, other adverse events | Observational Cohort: SEQ-HN | 0 | 0 |
| Total, serious adverse events | Tipifarnib Treatment Cohort: AIM-HN | 28 | 59 |
| Total, serious adverse events | Observational Cohort: SEQ-HN | 0 | 0 |
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 |
|---|
| Tipifarnib Treatment Cohort: AIM-HN vs Observational Cohort: SEQ-HN: deaths from any cause |
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.
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