Trial · NCT02807272
Tipifarnib in Subjects With Chronic Myelomonocytic Leukemia, Other MDS/MPN, and Acute Myeloid Leukemia
NCT02807272, Phase 2, Completed, Kura Oncology, Inc.; results first posted 2024-07-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tipifarnib in Subjects With Chronic Myelomonocytic Leukemia, Other MDS/MPN, and Acute Myeloid Leukemia. Trials, record NCT02807272. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02807272
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tipifarnib in Subjects With Chronic Myelomonocytic Leukemia, Other MDS/MPN, and Acute Myeloid Leukemia
- NCT number
- NCT02807272
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 44 participants, actual
- Lead sponsor
- Kura Oncology, Inc.
- Conditions
- Leukemia, Myelomonocytic, Chronic
- Interventions
- Tipifarnib
- First posted
- 2016-06-21
- Last updated
- 2024-07-17
- Results first posted
- 2024-07-17
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Up to 12 months | The ORR was estimated based on the number of participants who achieved an objective response (OR) (complete response \[CR\], complete cytogenetic remission \[CCR\], partial remission \[PR\], marrow response \[MR\], or clinical benefit \[CB\] performed by Principal Investigator according to the MDS/MPN International Working Group \[IWG\] criteria). |
| Secondary | Duration of Response (DoR) | Up to approximately 15 months | DoR was measured from the date the participant first met the criteria of an OR to the date that the participant progressed or until death from any cause during the period of disease assessments. Participants without progression or death were censored at the date of the last disease assessment. Participants who received subsequent anticancer therapy were censored at the date of last disease assessment before subsequent anticancer therapy. The median duration of response and corresponding 95% CI was estimated using the Kaplan Meier method. |
| Secondary | Progression Free Survival (PFS) | 1 year | The PFS time was defined as the time from the date of consent signed to the date of documented disease progression or death due to any cause, whichever occurred first. Participants without progression or death were censored at the date of the last disease assessment. Participants who received subsequent anticancer therapy were censored at the date of the last disease assessment before subsequent anticancer therapy. The Kaplan-Meier product-limit method was used to estimate the 1-year PFS rate, as well as the corresponding 95% CI. |
| Secondary | Overall Survival (OS) | Up to approximately 15 months | OS time was defined as the time from the date of consent signed to the date of death due to any cause. Participants who were alive or lost to follow-up by the end of the study were censored at the date last known to be alive. The Kaplan-Meier method was used to estimate the proportion (%) of subjects without an event at 12 months, as well as their corresponding 95% CI. |
| Secondary | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Up to approximately 3 years | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with it. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE severity was rated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03.: grade 1(mild), grade 2(moderate), grade 3(severe), grade 4(life-threatening), grade 5(death). An AE was considered serious if resulted in any of the following: death, life-threatening, caused inpatient hospitalization or prolonged it, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital abnormality/birth defect, or was an important medical event. |
Source ClinicalTrials.gov
Outcomes5
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) | Up to 12 months | Per Protocol Analysis Set (PP Analysis Set): Included participants who received at least 1 dose of tipifarnib and had a baseline disease assessment and at least 1 postbaseline disease assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DoR) | Up to approximately 15 months | PP Analysis Set: Included participants who received at least 1 dose of tipifarnib and had a baseline disease assessment and at least 1 postbaseline disease assessment. Only participants who met the criteria for an OR and progressed or died were included in the analysis. | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | 1 year | PP Analysis Set: Included participants who received at least 1 dose of tipifarnib and had a baseline disease assessment and at least 1 post-baseline disease assessment. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to approximately 15 months | PP Analysis Set: Included participants who received at least 1 dose of tipifarnib and had a baseline disease assessment and at least 1 post-baseline disease assessment. | months | MEDIAN |
| SECONDARY | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Up to approximately 3 years | FAS: All enrolled participants who received at least one dose of tipifarnib. Data was pooled into CMML and MDS/MPN arms as pre-specified in statistical analysis plan (SAP). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group52
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) | KRAS/NRAS WT | CR | 0 | Participants | |
| Objective Response Rate (ORR) | KRAS/NRAS Mut | CR | 0 | Participants | |
| Objective Response Rate (ORR) | KRAS/NRAS Missing | CR | 0 | Participants | |
| Objective Response Rate (ORR) | CXCR4/2 High | CR | 0 | Participants | |
| Objective Response Rate (ORR) | CXCR4/2 Low | CR | 0 | Participants | |
| Objective Response Rate (ORR) | KRAS/NRAS WT | CCR | 0 | Participants | |
| Objective Response Rate (ORR) | KRAS/NRAS Mut | CCR | 1 | Participants | |
| Objective Response Rate (ORR) | KRAS/NRAS Missing | CCR | 0 | Participants | |
| Objective Response Rate (ORR) | CXCR4/2 High | CCR | 0 | Participants | |
| Objective Response Rate (ORR) | CXCR4/2 Low | CCR | 0 | Participants |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | KRAS/NRAS WT | 23 | |
| Overall Study | STARTED | KRAS/NRAS Mut | 12 | |
| Overall Study | STARTED | KRAS/NRAS Missing | 2 | |
| Overall Study | STARTED | CXCR4/2 High | 3 | |
| Overall Study | STARTED | CXCR4/2 Low | 4 | |
| Overall Study | COMPLETED | KRAS/NRAS WT | 3 | |
| Overall Study | COMPLETED | KRAS/NRAS Mut | 4 | |
| Overall Study | COMPLETED | KRAS/NRAS Missing | 0 | |
| Overall Study | COMPLETED | CXCR4/2 High | 0 | |
| Overall Study | COMPLETED | CXCR4/2 Low | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events290
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 | CMML | 25 | 37 | |
| other | Anaemia | Blood and lymphatic system disorders | MDS/MPS | 4 | 7 | |
| other | Leukocytosis | Blood and lymphatic system disorders | CMML | 3 | 37 | |
| other | Leukocytosis | Blood and lymphatic system disorders | MDS/MPS | 1 | 7 | |
| other | Sinus tachycardia | Cardiac disorders | CMML | 4 | 37 | |
| other | Sinus tachycardia | Cardiac disorders | MDS/MPS | 0 | 7 | |
| other | Nausea | Gastrointestinal disorders | CMML | 22 | 37 | |
| other | Nausea | Gastrointestinal disorders | MDS/MPS | 6 | 7 | |
| other | Diarrhoea | Gastrointestinal disorders | CMML | 22 | 37 | |
| other | Diarrhoea | Gastrointestinal disorders | MDS/MPS | 3 | 7 |
1 to 10 of 290Source ClinicalTrials.gov
See all 290 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CMML | 17 | 37 |
| Total, all-cause mortality | MDS/MPS | 1 | 7 |
| Total, other adverse events | CMML | 37 | 37 |
| Total, other adverse events | MDS/MPS | 7 | 7 |
| Total, serious adverse events | CMML | 23 | 37 |
| Total, serious adverse events | MDS/MPS | 1 | 7 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CMML vs MDS/MPS: deaths from any cause | Trial comparisons |
| CMML vs MDS/MPS: 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/NCT02807272
GET https://conductscience.org/api/trials/v1/NCT02807272/results?page=2