A Phase 1 Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

Official title:

A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors Harboring ROS1 or NTRK1-3 Rearrangements

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05828303
• Other study ID #: CA127-1027
• Status: Recruiting
• Phase: Phase 1
• Start date: June 28, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: April 2024
• Source: Turning Point Therapeutics, Inc.
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: November 30, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary central nervous system [CNS] tumors) that harbors a ROS1 or NTRK1-3 gene fusion.

2. Patient must have a documented ROS1 or NTRK1-3 gene fusion determined by tissue-based local testing.

3. Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 (= 18 years).

4. Protocol specified baseline hematology, liver function and kidney function laboratory values.

Key Exclusion Criteria:

1. Concurrent participation in another therapeutic clinical trial.

2. Symptomatic brain metastases or leptomeningeal involvement.

3. Major surgery within 4 weeks of start of repotrectinib treatment.

4. Clinically significant cardiovascular disease.

5. History of non-pharmacologically induced prolonged QTc interval

6. Known active infections requiring ongoing treatment (bacterial, fungal, viral including human immunodeficiency virus positivity).

7. Gastrointestinal disease or other malabsorption syndromes.

8. Current or anticipated use of drugs that are known to be moderate or strong CYP3A inhibitors or inducers.

9. Patients who have received, or are expected to receive metformin, digoxin or rosuvastatin within 14 days prior to beginning of the DDI assessment period.

10. Patients who have received or are expected to receive drugs that are inhibitors of P-gp, OATP1B1, BCRP, and MATE2-K within 14 days or 5 half-lives (whichever is longer) prior to beginning of the DDI assessment period until the DDI assessment period is completed.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Metastatic Solid Tumor
• Neoplasms

Intervention

Drug:
• TPX-0005
Oral TPX-0005 capsules
• Metformin Hydrochloride
oral solution
• Digoxin
oral tablet
• Rosuvastatin Calcium
oral tablet

Locations

Country	Name	City	State
United States	Gabrail Cancer Research Center	Canton	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Turning Point Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximum Observed Plasma Concentration	Cmax: maximum observed plasma concentration	Within 28 days of first cocktail dose
Secondary	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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting