Trial · NCT05693090
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| 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 |
| Secondary | To study pharmacokinetics (PK) of tipifarnib and osimertinib in combination | Cycles 1-6 (28 day treatment cycle) | Terminal elimination rate constant |
| Secondary | To study pharmacokinetics (PK) of tipifarnib and osimertinib in combination | Cycles 1-6 (28 day treatment cycle) | Terminal half-life |
| Secondary | To study pharmacokinetics (PK) of tipifarnib and osimertinib in combination | Cycles 1-6 (28 day treatment cycle) | Apparent clearance and apparent volume of distribution |
| Secondary | To evaluate circulating tumor DNA (ctDNA) as an indicator or response in both ctDNA positive and negative patients by changes in genetic alterations | Monthly for duration of trial participation (an average of 2 years) | Determine prevalence of tumor-derived genetic alterations of ctDNA collected at baseline, on-treatment and at disease progression |
| Secondary | To evaluate circulating tumor DNA (ctDNA) clearance rates for patients positive at baseline | Monthly for duration of trial participation (an average of 2 years) | Clearance rates for patients who are ctDNA positive at baseline |
| Secondary | To evaluate circulating tumor DNA (ctDNA) time to detection changes associated with disease progression | Monthly for duration of trial participation (an average of 2 years) | Time to detection of ctDNA changes associated with disease progression |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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