Trial · NCT05693090
Tipifarnib and Osimertinib in EGFR-mutated Non-Small Cell Lung Cancer
NCT05693090, Phase 1, Withdrawn, Kura Oncology, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tipifarnib and Osimertinib in EGFR-mutated Non-Small Cell Lung Cancer. Trials, record NCT05693090. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05693090
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tipifarnib and Osimertinib in EGFR-mutated Non-Small Cell Lung Cancer
- NCT number
- NCT05693090
- Status
- Withdrawn
- Phases
- Phase 1
- Enrollment
- 0 participants, actual
- Lead sponsor
- Kura Oncology, Inc.
- Conditions
- NSCLC
- Interventions
- Tipifarnib, Osimertinib
- First posted
- 2023-01-20
- Last updated
- 2023-03-06
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | For Dose Escalation determine a safe and tolerable Phase 2 dose of tipifarnib when used in combination with osimertinib | At the end of Cycle 1 (each cycle is 28 days) | Occurrence of DLTs during first treatment cycle |
| Primary | For Dose Escalation characterize the safety of the combination DLTs will be listed for patients who complete the evaluation period for DLT | DLTs will be evaluated at the end of cycle 1 (28 days), but also through study completion, an average of 1.5 years | Descriptive statistics of adverse events per NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0) |
| Primary | For Dose Expansion characterize the safety profile of tipifarnib in combination with osimertinib as per NCI CTCAE v5.0 using descriptive statistics of adverse events | Through study completion, an average of 2 years | Descriptive statistics of adverse events per the NCI CTCAE v5.0 |
| Primary | For Dose Expansion characterize the safety profile of tipifarnib in combination with osimertinib as per NCI CTCAE v5.0 using the percentage of patients who discontinue the combination for related adverse events | First 6 cycles of treatment (28 day treatment cycle) | Percentage of patients who discontinue the combination for tipifarnib and/or osimertinib related adverse events prior to completing 6 cycles of treatment |
| Secondary | To evaluate the efficacy of tipifarnib in combination with osimertinib | Assessed every 8 weeks for the first year and every 12 weeks thereafter up to end of study at approximately 2 years | Objective Response Rate (ORR), measures evaluated according to RECIST v.1.1 assessed by investigator |
| Secondary | To evaluate the efficacy of tipifarnib in combination with osimertinib | Assessed every 8 weeks for the first year and every 12 weeks thereafter up to end of study at approximately 2 years | Duration of Response (DOR) assessed from (CR) or (PR) until (PD), initiation of new anticancer treatment or study withdrawal |
| Secondary | To evaluate the efficacy of tipifarnib in combination with osimertinib | Assessed every 8 weeks for the first year and every 12 weeks thereafter up to end of study at approximately 2 years | Progression-free survival (PFS) measures evaluated according to RECIST v.1.1 assessed by investigator |
| Secondary | To study pharmacokinetics (PK) of tipifarnib and osimertinib in combination | Cycles 1-6 (28 day treatment cycle) | Area under the concentration-time curve (AUC) from time 0 to time of last concentration measured and from time 0 extrapolated to infinity |
| Secondary | To study pharmacokinetics (PK) of tipifarnib and osimertinib in combination | Cycles 1-6 (28 day treatment cycle) | Maximum plasma concentration |
| Secondary | To study pharmacokinetics (PK) of tipifarnib and osimertinib in combination | Cycles 1-6 (28 day treatment cycle) | Time to maximum observed concentration |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT05693090
GET https://conductscience.org/api/trials/v1/NCT05693090/registered