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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

PHASE1NOT_YET_RECRUITING

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.

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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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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.

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

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

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

Exclusion criteria

Concurrent participation in another therapeutic clinical trial.

Symptomatic brain metastases or leptomeningeal involvement.

Major surgery within 4 weeks of start of repotrectinib treatment.

Clinically significant cardiovascular disease.

History of non-pharmacologically induced prolonged QTc interval

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

Gastrointestinal disease or other malabsorption syndromes.

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

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

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.

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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

Condition: Advanced Solid Tumor, Metastatic Solid Tumor
DRUG: TPX-0005 and other drugs
Westmead, New South Wales, Australia and more
Sponsor: Turning Point Therapeutics, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

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) Phase 1 Oral repotrectinib (TPX-0005) + cocktail drugs (metformin hydrochloride, digoxin, rosuvastatin calcium)	DRUG: TPX-0005 Oral TPX-0005 capsules

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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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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