A study to evaluate the drug-drug interaction potential of pralsetinib in combination with substrates of various transporters or CYP enzymes in participants with advanced or metastatic solid tumors that are not responsive to standard therapies

Phase 1

• Conditions: Solid tumors; Cancer

• Registration Number: ISRCTN14442671
• Lead Sponsor: F. Hoffmann-La Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-05
• Last Update Posted: 18 June 2024
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Participants who are 18 years or more at the time of informed consent
2. Eastern Cooperative Oncology Group (ECOG) performance =2
3. Participants with histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumours that are not responsive to standard therapies or for which there is no effective therapy

Exclusion Criteria

1. Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant
2. Surgery (e.g., stomach bypass) or medical condition that might significantly affect the absorption of medicines (as judged by the investigator)
3. History of pneumonitis within the last 12 months
4. History of active or latent tuberculosis, regardless of treatment history, or has a positive screening test for latent mycobacterium tuberculosis infection
5. Serious infection requiring intravenous or systemic antibiotics within 7 days prior to initiation of study treatment
6. Cardiovascular issues
7. Central nervous system (CNS) metastases or a primary CNS tumor that is associated with progressive neurological symptoms or requires increasing doses of corticosteroids to control the CNS disease
8. Radiotherapy or radiosurgery to any site within 14 days before check-in or more than 30 Gy of radiotherapy to the lung in the 6 months before check-in
9. Medical conditions or underlying diseases that constitute contraindications on the use of the substrates or probes used in this study including hypersensitivity to the drugs administered during the study
10. Participation in another investigational drug trial within 30 days prior to study drug administration or exposure to more than 3 new investigational agents within 12 months prior to study drug administration
11. Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody at screening. A negative polymerase chain reaction (PCR) test overrides a positive serological test.
12. Human immunodeficiency virus (HIV) antibodies 1/2 at screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified