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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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).
Time frame: Within 28 days of first cocktail dose
Maximum Observed Plasma Concentration
Cmax: maximum observed plasma concentration
Time frame: Within 28 days of first cocktail dose
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
Time frame: Within 28 days of first cocktail dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
oral tablet
Gabrail Cancer Research Center
Canton, Ohio, United States
Local Institution - 2101
Canton, Ohio, United States
Local Institution - 2119
Westmead, New South Wales, Australia
Local Institution - 2126
Botafogo, Rio de Janeiro, Brazil
Local Institution - 2132
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 2134
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 2130
São Paulo, São Paulo, Brazil
Local Institution - 2108
São Paulo, Brazil
Local Institution - 2123
Bordeaux, France
Local Institution - 2122
La Tronche, France
...and 23 more locations