Trial · NCT03496766
Tipifarnib in Advanced Squamous NSCLC With Oncogen HRAS MutAtionS
NCT03496766, Phase 2, Terminated, Spanish Lung Cancer Group; results first posted 2024-03-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tipifarnib in Advanced Squamous NSCLC With Oncogen HRAS MutAtionS. Trials, record NCT03496766. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03496766
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tipifarnib in Advanced Squamous NSCLC With Oncogen HRAS MutAtionS
- NCT number
- NCT03496766
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Spanish Lung Cancer Group
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Tipifarnib
- First posted
- 2018-04-12
- Last updated
- 2025-03-05
- Other registries' IDs
- eudract:2017-004822-13
- Results first posted
- 2024-03-29
- Limitations and caveats
- The recruitment was closed prematurely to due to slow recruitment, so there are no consistent data to achieve any relevant conclusion at this point.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response | From the first dose until progression disease, assessed from the first dose until the first assessment at week 6 from the first dose | To determine the antitumor activity in terms of objective response rate (ORR) of tipifarnib in subjects with locally advanced unresectable or metastatic, relapsed and/or refractory, squamous non-small cell lung cancer (SQ-NSCLC) with HRAS mutations. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions. |
| Secondary | Progression Free Survival | From the start of treatment until first progression or death. | Defined as the time from the start date of treatment TMT as the origin of follow-up and the first progression or death as final date. |
| Secondary | Overall Survival | From the date of randomization until end of follow up,up to 24 months | Defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response | From the first dose until progression disease, assessed from the first dose until the first assessment at week 6 from the first dose | Per protocol population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival | From the start of treatment until first progression or death. | months | MEDIAN | |
| SECONDARY | Overall Survival | From the date of randomization until end of follow up,up to 24 months | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response | Experimental Arm | Stable Disease | 2 | Participants | |
| Overall Response | Experimental Arm | Progression Disease | 4 | Participants | |
| Progression Free Survival | Experimental Arm | 8.6 | Standard Deviation 18.7 | months | |
| Overall Survival | Experimental Arm | 12.4 | Full Range 9.7 to 21.7 | Months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental Arm | 9 | |
| Overall Study | COMPLETED | Experimental Arm | 9 | |
| Overall Study | NOT COMPLETED | Experimental Arm | 0 |
Source ClinicalTrials.gov
Adverse events11
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 | Anemia | Blood and lymphatic system disorders | Experimental Arm | 9 | 9 | 9 |
| other | Hyperglycemia | Investigations | Experimental Arm | 7 | 9 | 7 |
| other | Confusion | General disorders | Experimental Arm | 1 | 9 | 1 |
| serious | Renal and urinary disorders | Renal and urinary disorders | Experimental Arm | 6 | 9 | 6 |
| serious | Acute kidney injury | Renal and urinary disorders | Experimental Arm | 1 | 9 | 1 |
| serious | Fatigue | General disorders | Experimental Arm | 1 | 9 | 1 |
| serious | Dyspnea | Respiratory, thoracic and mediastinal disorders | Experimental Arm | 2 | 9 | 2 |
| serious | Platelet count decreased | Blood and lymphatic system disorders | Experimental Arm | 2 | 9 | 2 |
| serious | Nervous system disorders | Nervous system disorders | Experimental Arm | 1 | 9 | 1 |
| serious | Thromboembolic event | Blood and lymphatic system disorders | Experimental Arm | 1 | 9 | 1 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental Arm | 9 | 9 |
| Total, other adverse events | Experimental Arm | 9 | 9 |
| Total, serious adverse events | Experimental Arm | 9 | 9 |
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.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Trail Making Test A | Secondary outcome |
Source ConductCognition
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/NCT03496766
GET https://conductscience.org/api/trials/v1/NCT03496766/registered