Trial · NCT02383927
Phase II Study of Tipifarnib in Squamous Head and Neck Cancer With HRAS Mutations
NCT02383927, Phase 2, Completed, Kura Oncology, Inc.; results first posted 2024-07-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase II Study of Tipifarnib in Squamous Head and Neck Cancer With HRAS Mutations. Trials, record NCT02383927. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02383927
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Tipifarnib in Squamous Head and Neck Cancer With HRAS Mutations
- NCT number
- NCT02383927
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 63 participants, actual
- Lead sponsor
- Kura Oncology, Inc.
- Conditions
- Thyroid Cancer, Squamous Cell Carcinoma Head and Neck Cancer (HNSCC), HRAS Mutant Tumor, Other Squamous Cell Carcinoma (SCC) With HRAS Mutant Tumor
- Interventions
- Tipifarnib
- First posted
- 2015-03-10
- Last updated
- 2024-07-11
- Results first posted
- 2024-07-11
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Antitumor Activity by Objective Response Rate (ORR) | Up to approximately 3 years | The ORR of tipifarnib was response assessments according to RECIST 1.1. The estimate of the ORR was calculated based on the maximum likelihood estimator (i.e., crude percentage of subjects whose best overall response was complete response \[CR\] or partial response \[PR\]). The estimate of the ORR was accompanied by 2-sided 95% confidence interval (CI). The 95% CI was estimated using the Wilson score test-based method. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. |
| Secondary | Number of Subjects That Experienced One or More Treatment-emergent Adverse Events (TEAEs) | Up to approximately 3 years | An adverse event (AE) was any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs that started on or after the first dose of study drug and within 30 days of the last administration of study drug or immediately before the initiation of any other anticancer therapy. The Investigator was required to grade the severity/ intensity of each AE according to NCI-CTCAE version 4.03. If a severity/intensity of Grade 4 (life-threatening) or 5 (death) was applied to an AE, then the Investigator also reported the event as a serious AE. |
| Other | Progression-free Survival (PFS) | Up to approximately 3 years | PFS was defined as the time from first dose (Cycle 1 Day 1) to either first observation of progressive disease (PD) or occurrence of death due to any cause within 126 days (approximately 2 time-intervals for tumour assessments) of either first administration of tipifarnib or the last tumour assessment. Observation of PD could have been by either documented radiographic progression (i.e., scan results) or documentation of symptomatic or clinical progression agreed upon and documented by investigators. In subjects without a progression date or with a death date more than 126 days after the first administration of study drugs or the last tumour assessment, the PFS time should have been censored on the date of last tumour assessment or date of first administration of study tipifarnib. |
| Other | Duration of Response (DOR) | Up to approximately 3 years | DOR was the number of months from start date of PR or CR (whichever response was achieved first) to the first date that PD was documented (in subjects with an objective response). PD was determined by the Investigator using RECIST 1.1. The DOR was right-censored at the date for subjects who achieved CR or PR and met one of the following conditions: 1) when non-protocol anticancer treatment started before documentation of PD, 2) when death prior to documented PD or documented PD after more than 1 missed disease assessment visit, or 3) when alive and did not have documentation of PD before a data analysis cut-off date (therefore, analysis cut-off date was used as the censoring date). Median and 95% CI were calculated via Kaplan-Meier analysis. |
| Other | Overall Survival (OS) | Up to approximately 4 years | An analysis of OS was conducted to estimate median OS time and corresponding 95% CI. OS was defined as the time from first dose (Cycle 1 Day 1) to the occurrence of death due to any cause. In subjects without a death date, the OS was censored on 1) the last date of survival status if alive, 2) a data analysis cut-off date for subjects with no survival status documentation, or 3) the date a subject withdrew consent or was lost to follow-up if there was no additional information. Median and 95% CI were calculated via Kaplan-Meier analysis. |
| Other | Antitumor Activity - Best Overall Response (BOR) | Up to approximately 3 years | BOR according to RECIST 1.1. Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. |
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 | Antitumor Activity by Objective Response Rate (ORR) | Up to approximately 3 years | The Full Analysis Set (FAS) Population excluding subjects for the following reasons: no baseline data; failure to receive at least 1 dose of tipifarnib; no post-baseline endpoint data subsequent to at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Number of Subjects That Experienced One or More Treatment-emergent Adverse Events (TEAEs) | Up to approximately 3 years | The ASaT Population consists of all enrolled subjects who received at least 1 dose of tipifarnib. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Progression-free Survival (PFS) | Up to approximately 3 years | The FAS Population excluding subjects for the following reasons: no baseline data; failure to receive at least 1 dose of tipifarnib; no post-baseline endpoint data subsequent to at least 1 dose of study drug. | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Duration of Response (DOR) | Up to approximately 3 years | The Per Protocol (PP) Population was a subset of the FAS population that excluded subjects due to major deviations from the protocol that may have substantially affected the results of the primary analysis. Only participants participants with response data were included. | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Overall Survival (OS) | Up to approximately 4 years | The FAS Population excluding subjects for the following reasons: no baseline data; failure to receive at least 1 dose of tipifarnib; no post-baseline endpoint data subsequent to at least 1 dose of study drug. | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Antitumor Activity - Best Overall Response (BOR) | Up to approximately 3 years | The FAS Population excluding subjects for the following reasons: no baseline data; failure to receive at least 1 dose of tipifarnib; no post-baseline endpoint data subsequent to at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Antitumor Activity by Objective Response Rate (ORR) | Cohort 1 | 0.0 | 95% Confidence Interval 0.0 to 25.9 | percentage of participants | |
| Antitumor Activity by Objective Response Rate (ORR) | Cohort 2/Stage 1 | 0.0 | 95% Confidence Interval 0.0 to 32.4 | percentage of participants | |
| Antitumor Activity by Objective Response Rate (ORR) | Cohort 2/Stage 2 | 43.5 | 95% Confidence Interval 25.6 to 63.2 | percentage of participants | |
| Antitumor Activity by Objective Response Rate (ORR) | Cohort 3 | 28.6 | 95% Confidence Interval 8.2 to 64.1 | percentage of participants | |
| Number of Subjects That Experienced One or More Treatment-emergent Adverse Events (TEAEs) | Cohort 1 | TEAEs | 13 | Participants | |
| Number of Subjects That Experienced One or More Treatment-emergent Adverse Events (TEAEs) | Cohort 2/Stage 1 | TEAEs | 10 | Participants | |
| Number of Subjects That Experienced One or More Treatment-emergent Adverse Events (TEAEs) | Cohort 2/Stage 2 | TEAEs | 30 | Participants | |
| Number of Subjects That Experienced One or More Treatment-emergent Adverse Events (TEAEs) | Cohort 3 | TEAEs | 10 | Participants | |
| Number of Subjects That Experienced One or More Treatment-emergent Adverse Events (TEAEs) | Cohort 1 | Serious TEAEs | 6 | Participants | |
| Number of Subjects That Experienced One or More Treatment-emergent Adverse Events (TEAEs) | Cohort 2/Stage 1 | Serious TEAEs | 5 | Participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 13 | |
| Overall Study | STARTED | Cohort 2/Stage 1 | 10 | |
| Overall Study | STARTED | Cohort 2/Stage 2 | 30 | |
| Overall Study | STARTED | Cohort 3 | 10 | |
| Overall Study | COMPLETED | Cohort 1 | 0 | |
| Overall Study | COMPLETED | Cohort 2/Stage 1 | 0 | |
| Overall Study | COMPLETED | Cohort 2/Stage 2 | 0 | |
| Overall Study | COMPLETED | Cohort 3 | 0 | |
| Overall Study | NOT COMPLETED | Cohort 1 | 13 | |
| Overall Study | NOT COMPLETED | Cohort 2/Stage 1 | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events928
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 | Cohort 1 | 2 | 13 | |
| other | Hypertension | Vascular disorders | Cohort 2/Stage 1 | 2 | 10 | |
| other | Hypertension | Vascular disorders | Cohort 2/Stage 2 | 1 | 30 | |
| other | Hypertension | Vascular disorders | Cohort 3 | 0 | 10 | |
| other | Blood pressure fluctuation | Vascular disorders | Cohort 1 | 0 | 13 | |
| other | Blood pressure fluctuation | Vascular disorders | Cohort 2/Stage 1 | 1 | 10 | |
| other | Blood pressure fluctuation | Vascular disorders | Cohort 2/Stage 2 | 0 | 30 | |
| other | Blood pressure fluctuation | Vascular disorders | Cohort 3 | 0 | 10 | |
| other | Deep vein thrombosis | Vascular disorders | Cohort 1 | 0 | 13 | |
| other | Deep vein thrombosis | Vascular disorders | Cohort 2/Stage 1 | 0 | 10 |
1 to 10 of 928Source ClinicalTrials.gov
See all 928 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 6 | 13 |
| Total, all-cause mortality | Cohort 2/Stage 1 | 9 | 10 |
| Total, all-cause mortality | Cohort 2/Stage 2 | 24 | 30 |
| Total, all-cause mortality | Cohort 3 | 9 | 10 |
| Total, other adverse events | Cohort 1 | 13 | 13 |
| Total, other adverse events | Cohort 2/Stage 1 | 10 | 10 |
| Total, other adverse events | Cohort 2/Stage 2 | 29 | 30 |
| Total, other adverse events | Cohort 3 | 9 | 10 |
| Total, serious adverse events | Cohort 1 | 6 | 13 |
| Total, serious adverse events | Cohort 2/Stage 1 | 5 | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33750196 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02383927
GET https://conductscience.org/api/trials/v1/NCT02383927/results?page=2