Trial · NCT02779777
Tipifarnib in Subjects With Myelodysplastic Syndromes
NCT02779777, Phase 2, Terminated, Kura Oncology, Inc.; results first posted 2024-07-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tipifarnib in Subjects With Myelodysplastic Syndromes. Trials, record NCT02779777. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02779777
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tipifarnib in Subjects With Myelodysplastic Syndromes
- NCT number
- NCT02779777
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- Kura Oncology, Inc.
- Conditions
- Myelodysplastic Syndromes
- Interventions
- Tipifarnib
- First posted
- 2016-05-20
- Last updated
- 2024-07-31
- Results first posted
- 2024-07-31
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | 1 year | ORR was assessed by the investigator and included complete response (CR), partial response (PR), marrow complete remission (MR), and hematologic improvement (HI) according to the MDS International Working Group (IWG) criteria. |
| Secondary | Rate of Transfusion Independence | 1 year | Rate of transfusion independence is defined as number of participants with transfusion independence at any response assessment over 1 year. |
| Secondary | Duration of Transfusion Independence | 1 year | Duration of transfusion independence is defined as the period of time where participants achieved transfusion independence. |
| Secondary | Hematologic Improvement | 1 year | Number of subjects who experienced hematologic improvements (erythroid response, platelet response, or neutrophil response). |
| Secondary | Duration of Response | 1 year | Duration of response is defined as the number of days from the start date of response (whichever response is achieved first) to the first date that progressive disease is objectively documented. |
| Secondary | Progression-free Survival (PFS) at 1 Year | 1 year | PFS is defined as the time (in months) from enrollment to either first observation of progressive disease or occurrence of death due to any cause within 1 year (approximately 4 time intervals for disease assessments) of either first administration of tipifarnib or the last disease assessment. |
| Secondary | Overall Survival (OS) at 1 Year | 1 year | OS is defined as the time (in months) from enrollment to occurrence of death due to any cause within 1 year (approximately 4 time intervals for disease assessments) of either first administration of tipifarnib or the last disease assessment. |
| Secondary | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | 1 year | TEAEs are defined as AEs that started on or after the first dose of study drug and within approximately 30 days of the last administration of study drug. AEs were summarized by the number and percentage of subjects who experienced the event, according to system organ class and preferred term. A subject reporting multiple cases of the same AE will be counted once within each system organ class and similarly counted once within each preferred term. |
Source ClinicalTrials.gov
Outcomes8
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) | 1 year | Full analysis set (FAS) includes subjects enrolled in Protocol Amendment 3 (version 09 Jul 2017) and received at least one dose of tipifarnib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rate of Transfusion Independence | 1 year | FAS includes subjects enrolled in Protocol Amendment 3 (version 09 Jul 2017) and received at least one dose of tipifarnib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Transfusion Independence | 1 year | FAS includes subjects enrolled in Protocol Amendment 3 (version 09 Jul 2017) and received at least one dose of tipifarnib. | ||
| SECONDARY | Hematologic Improvement | 1 year | FAS includes subjects enrolled in Protocol Amendment 3 (version 09 Jul 2017) and received at least one dose of tipifarnib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response | 1 year | FAS includes subjects enrolled in Protocol Amendment 3 (version 09 Jul 2017) and received at least one dose of tipifarnib. | ||
| SECONDARY | Progression-free Survival (PFS) at 1 Year | 1 year | FAS includes subjects enrolled in Protocol Amendment 3 (version 09 Jul 2017) and received at least one dose of tipifarnib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) at 1 Year | 1 year | FAS includes subjects enrolled in Protocol Amendment 3 (version 09 Jul 2017) and received at least one dose of tipifarnib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | 1 year | The All Subjects as Treated (ASaT) population consisted of all enrolled subjects who received at least 1 dose of tipifarnib. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group25
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) | Original Cohort | 0 | Participants | ||
| Objective Response Rate (ORR) | Regimen 1: Tipifarnib | 0 | Participants | ||
| Objective Response Rate (ORR) | Regimen 2: Tipifarnib | 0 | Participants | ||
| Rate of Transfusion Independence | Original Cohort | 0 | Participants | ||
| Rate of Transfusion Independence | Regimen 1: Tipifarnib | 0 | Participants | ||
| Rate of Transfusion Independence | Regimen 2: Tipifarnib | 0 | Participants | ||
| Hematologic Improvement | Original Cohort | 0 | Participants | ||
| Hematologic Improvement | Regimen 1: Tipifarnib | 0 | Participants | ||
| Hematologic Improvement | Regimen 2: Tipifarnib | 1 | Participants | ||
| Progression-free Survival (PFS) at 1 Year | Regimen 1: Tipifarnib | 0 | Participants |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Original Cohort | 14 | |
| Overall Study | STARTED | Regimen 1: Tipifarnib | 1 | |
| Overall Study | STARTED | Regimen 2: Tipifarnib | 1 | |
| Overall Study | COMPLETED | Original Cohort | 0 | |
| Overall Study | COMPLETED | Regimen 1: Tipifarnib | 0 | |
| Overall Study | COMPLETED | Regimen 2: Tipifarnib | 0 | |
| Overall Study | NOT COMPLETED | Original Cohort | 14 | |
| Overall Study | NOT COMPLETED | Regimen 1: Tipifarnib | 1 | |
| Overall Study | NOT COMPLETED | Regimen 2: Tipifarnib | 1 |
Source ClinicalTrials.gov
Adverse events171
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 | Thrombocytopenia | Blood and lymphatic system disorders | Original Cohort | 9 | 14 | 9 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Regimen 1: Tipifarnib | 0 | 1 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Regimen 2: Tipifarnib | 1 | 1 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Original Cohort | 6 | 14 | 6 |
| other | Neutropenia | Blood and lymphatic system disorders | Regimen 1: Tipifarnib | 1 | 1 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Regimen 2: Tipifarnib | 1 | 1 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Original Cohort | 2 | 14 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Regimen 1: Tipifarnib | 0 | 1 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Regimen 2: Tipifarnib | 0 | 1 | 0 |
| other | Cataract | Eye disorders | Original Cohort | 1 | 14 | 1 |
1 to 10 of 171Source ClinicalTrials.gov
See all 171 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Original Cohort | 0 | 14 |
| Total, all-cause mortality | Regimen 1: Tipifarnib | 0 | 1 |
| Total, all-cause mortality | Regimen 2: Tipifarnib | 0 | 1 |
| Total, other adverse events | Original Cohort | 14 | 14 |
| Total, other adverse events | Regimen 1: Tipifarnib | 1 | 1 |
| Total, other adverse events | Regimen 2: Tipifarnib | 1 | 1 |
| Total, serious adverse events | Original Cohort | 7 | 14 |
| Total, serious adverse events | Regimen 1: Tipifarnib | 0 | 1 |
| Total, serious adverse events | Regimen 2: Tipifarnib | 0 | 1 |
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 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/NCT02779777
GET https://conductscience.org/api/trials/v1/NCT02779777/results?page=2