Clinical drug-interaction study of pralsetinib in cancer patients
Research type
Research Study
Full title
A Phase 1, Two-arm, Open-label Study to Evaluate the Clinical Drug-Drug Interaction Potential of Pralsetinib in Combination with Sensitive Transporter Substrates, Sensitive CYP Substrates, or a Combined Oral Contraceptive in Patients with Advanced or Metastatic Solid Tumors that are not Responsive to Standard Therapies or for which there is no Effective Therapy
IRAS ID
1007197
Contact name
Mabel Dominguez
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd Genentech Research and Early Development
Eudract number
2022-001557-23
ISRCTN Number
ISRCTN14442671
Research summary
F. Hoffman-La Roche Ltd (the Sponsor) are running a phase 1, two-arm, open-label study to evaluate the clinical drug-drug interaction potential of pralsetinib. This study will be run in 2 study arms, Arm A & Arm B, with different types of drugs medications used as probes to see whether there is an interaction with pralsetinib.
The study is planned to involve 18 men or women aged 18 years or older per study arm who have advanced or metastatic solid tumours that are not responsive to standard therapies or for which there is no effective therapy. Women will have to be sterile or postmenopausal if they want to participate. Participants will be allocated to either treatment arm depending on local circumstances and requirements, including decisions made by the study doctor and/or following consultation by the sponsor. Study participants will visit the study site 4-5 times during the study, where they will be asked about medical history and general health. Participants will undergo procedures such as, blood and urine tests, ECGs, and a physical examination including weight and height measurements.
The probe medications will first be administered without pralsetinib to look at the levels of the probes in the participants bodies while they are unaffected by pralsetinib. Thereafter, pralsetinib will be administered once daily, and the probes will be administered again after pralsetinib has been given for a couple of days to see whether the levels of the probes change when they are given together with pralsetinib.
Safety will be monitored by the sponsor which will implement a risk-based quality management approach to ensure the quality of the study, focusing on processes and data that are critical to ensuring participant safety and data integrity. The study will be conducted in accordance with the ethical principles that have their origin in the World Medical Association (WMA) Declaration of Helsinki, and international GCP guidelines.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
23/SC/0105
Date of REC Opinion
30 Oct 2023
REC opinion
Further Information Unfavourable Opinion