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A Phase 1 Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors
This is a Phase 1 study to evaluate the potential drug-drug interaction (DDI) effect of repotrectinib on certain drug transporters in patients with advanced cancer.
Study details:
This is a Phase 1, open-label, fixed-sequence study to evaluate the potential drug-drug interaction (DDI) effect of repotrectinib on drug transporters (metformin, digoxin and rosuvastatin) following multiple dose administration of repotrectinib in patients with advanced cancer harboring ROS1 and NTRK1 Rearrangements.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-11-15
Primary completion: 2025-07-31
Study completion finish: 2025-11-30
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05828303
Intervention or treatment
DRUG: TPX-0005
DRUG: Metformin Hydrochloride
DRUG: Digoxin
DRUG: Rosuvastatin Calcium
Conditions
- • Advanced Solid Tumor
- • Metastatic Solid Tumor
Find a site
Closest Location:
Local Institution - 2119
Research sites nearby
Select from list below to view details:
Local Institution - 2119
Westmead, New South Wales, Australia
Local Institution - 2131
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Repotrectinib (TPX-0005)
| DRUG: TPX-0005
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Area under plasma-concentration time curve | AUC0-t: area under the plasma-concentration time curve from time 0 to time of the last measurable concentration. AUC0-inf: area under the plasma-concentration time curve from time 0 to infinity (if data permit). | Within 28 days of first cocktail dose |
Maximum Observed Plasma Concentration | Cmax: maximum observed plasma concentration | Within 28 days of first cocktail dose |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Evaluate safety and tolerability | To evaluate the safety and tolerability of repotrectinib in patients with moderate and severe hepatic impairment and patients with normal hepatic function following single and multiple dose administration of repotrectinib assessed by CTCAE v5.0 | Within 28 days of first cocktail dose |
Frequently Asked Questions
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