Trial · NCT02464228
Investigation of Tipifarnib in Treatment of Subjects With Peripheral T-Cell Lymphoma (PTCL) That Have Not Responded to Standard Therapy
NCT02464228, Phase 2, Completed, Kura Oncology, Inc.; results first posted 2024-06-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Investigation of Tipifarnib in Treatment of Subjects With Peripheral T-Cell Lymphoma (PTCL) That Have Not Responded to Standard Therapy. Trials, record NCT02464228. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02464228
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Investigation of Tipifarnib in Treatment of Subjects With Peripheral T-Cell Lymphoma (PTCL) That Have Not Responded to Standard Therapy
- NCT number
- NCT02464228
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 65 participants, actual
- Lead sponsor
- Kura Oncology, Inc.
- Conditions
- Relapsed or Refractory Peripheral T-Cell Lymphoma
- Interventions
- Tipifarnib
- First posted
- 2015-06-08
- Last updated
- 2024-06-26
- Results first posted
- 2024-06-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Up to approximately 3 years | The ORR (complete response \[CR\] or partial response \[PRs\]) of tipifarnib was based on response assessments according to the Lugano Classification. Two-sided 95% confidence intervals (CIs) were based on either Wilson approximation (N \> 4) or Clopper-Pearson method (N ≤ 4). CR: PET-CT-based response, score of 1-3 on five-point scale (5PS) for lymph nodes and extralymphatic sites, no evidence of fluorodeoxyglucose (FDG)-avid disease in marrow. CT-based response, target nodes and masses regress to 1.5 cm in longest transverse diameter, no extralymphatic sites of disease, normal bone marrow morphology. PR: PET-CT-based response, score of 4-5 on 5PS with reduced uptake compared to baseline for lymph nodes and extralymphatic sites, residual uptake reduced compared to baseline in the bone marrow. CT-based response, ≥ 50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites, spleen regressed by \> 50% in length beyond normal. |
| Secondary | Progression-free Survival (PFS) | Up to approximately 3 years | PFS was defined as the time (in months) 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 tumor assessments) of either first administration of tipifarnib or the last tumor 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 tumor assessment, the PFS time was censored on the date of last tumor assessment or date of first administration of study tipifarnib. The duration of the PFS was analyzed using the Kaplan-Meier (KM) method. 95% CIs were calculated using Hall-Wellner Method. |
| Secondary | Duration of Response (DOR) | Up to approximately 3 years | DOR was defined as the time (in months) from the start date of the objective response to the first date of either documented PD or death. No data imputations were conducted for missing data. In the event of a maintained response, the DOR was censored at the last evaluable non-PD assessment. The DOR was analyzed using the KM method. 95% CIs were calculated using Hall-Wellner Method. |
| 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. |
Source ClinicalTrials.gov
Outcomes4
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 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 | 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 |
| SECONDARY | Duration of Response (DOR) | 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 |
| 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 |
Source ClinicalTrials.gov
Results by group19
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) | Cohort AITL | 56.3 | 95% Confidence Interval 39.3 to 71.8 | percentage of participants | |
| Objective Response Rate (ORR) | Cohort PTCL-NOS | 7.1 | 95% Confidence Interval 0.2 to 33.9 | percentage of participants | |
| Objective Response Rate (ORR) | Cohort PTCL-NOS, CXCL12+ | 40.0 | 95% Confidence Interval 12.2 to 73.8 | percentage of participants | |
| Objective Response Rate (ORR) | Cohort Other | 0.0 | 95% Confidence Interval 0.0 to 84.2 | percentage of participants | |
| Progression-free Survival (PFS) | Cohort AITL | 3.6 | 95% Confidence Interval 1.9 to 8.3 | months | |
| Progression-free Survival (PFS) | Cohort PTCL-NOS | 2.1 | 95% Confidence Interval 1.4 to 4.0 | months | |
| Progression-free Survival (PFS) | Cohort PTCL-NOS, CXCL12+ | 5.3 | 95% Confidence Interval 1.8 to 11.1 | months | |
| Progression-free Survival (PFS) | Cohort Other | 1.4 | 95% Confidence Interval 1.1 to 1.6 | months | |
| Duration of Response (DOR) | Cohort AITL | 7.8 | 95% Confidence Interval 2.0 to 16.3 | months | |
| Duration of Response (DOR) | Cohort PTCL-NOS | 1.0 | 95% Confidence Interval NA to NA | months |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 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 AITL | 38 | |
| Overall Study | STARTED | Cohort PTCL-NOS | 14 | |
| Overall Study | STARTED | Cohort PTCL-NOS, CXCL12+ | 11 | |
| Overall Study | STARTED | Cohort Other | 2 | |
| Overall Study | COMPLETED | Cohort AITL | 2 | |
| Overall Study | COMPLETED | Cohort PTCL-NOS | 0 | |
| Overall Study | COMPLETED | Cohort PTCL-NOS, CXCL12+ | 0 | |
| Overall Study | COMPLETED | Cohort Other | 0 | |
| Overall Study | NOT COMPLETED | Cohort AITL | 36 | |
| Overall Study | NOT COMPLETED | Cohort PTCL-NOS | 14 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events904
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 | Deep vein thrombosis | Vascular disorders | Cohort AITL | 0 | 38 | |
| other | Deep vein thrombosis | Vascular disorders | Cohort PTCL-NOS | 1 | 14 | |
| other | Deep vein thrombosis | Vascular disorders | Cohort PTCL-NOS, CXCL12+ | 0 | 11 | |
| other | Deep vein thrombosis | Vascular disorders | Cohort Other | 0 | 2 | |
| other | Haematoma | Vascular disorders | Cohort AITL | 1 | 38 | |
| other | Haematoma | Vascular disorders | Cohort PTCL-NOS | 0 | 14 | |
| other | Haematoma | Vascular disorders | Cohort PTCL-NOS, CXCL12+ | 1 | 11 | |
| other | Haematoma | Vascular disorders | Cohort Other | 0 | 2 | |
| other | Hypotension | Vascular disorders | Cohort AITL | 8 | 38 | |
| other | Hypotension | Vascular disorders | Cohort PTCL-NOS | 2 | 14 |
1 to 10 of 904Source ClinicalTrials.gov
See all 904 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort AITL | 13 | 38 |
| Total, all-cause mortality | Cohort PTCL-NOS | 8 | 14 |
| Total, all-cause mortality | Cohort PTCL-NOS, CXCL12+ | 4 | 11 |
| Total, all-cause mortality | Cohort Other | 1 | 2 |
| Total, other adverse events | Cohort AITL | 38 | 38 |
| Total, other adverse events | Cohort PTCL-NOS | 14 | 14 |
| Total, other adverse events | Cohort PTCL-NOS, CXCL12+ | 11 | 11 |
| Total, other adverse events | Cohort Other | 2 | 2 |
| Total, serious adverse events | Cohort AITL | 21 | 38 |
| Total, serious adverse events | Cohort PTCL-NOS | 8 | 14 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38991123 | 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/NCT02464228
GET https://conductscience.org/api/trials/v1/NCT02464228/events?page=2