Clinical Trial: NCT04772235
Phase I Study of Repotrectinib and Osimertinib in NSCLC Patients
Status:
UNKNOWNPhase:
Phase 1| Lead Sponsor: | Instituto Oncológico Dr Rosell |
| Information Provided By: | Instituto Oncológico Dr Rosell |
| Last Update Posted: | 2024-04-03 |
Study Overview
Brief Summary
This is a Phase I study of repotrectinib in combination with osimertinib in patients with advanced or metastatic EGFR mutant non small cell lung cancer (NSCLC).
The study will be conducted in 2 parts, Part Ia and Part Ib, and its purpose will be to find the incidence of dose-limiting toxicities (DLTs) as defined by the primary safety and tolerability endpoint. The Phase Ia study will also determine the impact of repotrectinib on osimertinib pharmacokinetics (PK) and the maximum tolerated dose (MTD), if reached, of repotrectinib given in combination with osimertinib and the recommended Phase II dose (RP2D). Dose escalation will be conducted according to a 'Rolling-6' based study design with 3 dose levels for repotrectinib: 80 mg once a day (QD), 160 mg QD or 160 mf QD during 14 days followed by 160 mg twice a day (BID); in combination with 80 mg QD of osimertinib. A total of 6 patients will be enrolled in each dose level cohort.
In addition, this Phase Ib study will test early drug activity (efficacy) of the proposed combination treatment in an expansion cohort at the RP2D.
Official Title
Conditions
Intervention / Treatment
- Drug: Repotrectinib
- Drug: Osimertinib
Other Study ID Numbers
- IOR-TPT-IST-002
- 2020-005151-20
Start Date (Actual)
Primary Completion Date (Estimated)
Study Completion Date (Estimated)
Enrollment (Estimated)
Study Type
Phase
| Lead Sponsor: | Instituto Oncológico Dr Rosell |
| Information Provided By: | Instituto Oncológico Dr Rosell |
| Last Update Posted: | 2024-04-03 |
Study Overview
Brief Summary
This is a Phase I study of repotrectinib in combination with osimertinib in patients with advanced or metastatic EGFR mutant non small cell lung cancer (NSCLC).
The study will be conducted in 2 parts, Part Ia and Part Ib, and its purpose will be to find the incidence of dose-limiting toxicities (DLTs) as defined by the primary safety and tolerability endpoint. The Phase Ia study will also determine the impact of repotrectinib on osimertinib pharmacokinetics (PK) and the maximum tolerated dose (MTD), if reached, of repotrectinib given in combination with osimertinib and the recommended Phase II dose (RP2D). Dose escalation will be conducted according to a 'Rolling-6' based study design with 3 dose levels for repotrectinib: 80 mg once a day (QD), 160 mg QD or 160 mf QD during 14 days followed by 160 mg twice a day (BID); in combination with 80 mg QD of osimertinib. A total of 6 patients will be enrolled in each dose level cohort.
In addition, this Phase Ib study will test early drug activity (efficacy) of the proposed combination treatment in an expansion cohort at the RP2D.
Official Title
Conditions
Intervention / Treatment
- Drug: Repotrectinib
- Drug: Osimertinib
Other Study ID Numbers
- IOR-TPT-IST-002
- 2020-005151-20