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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

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

    trial

    Trial ID

    NCT05828303

    Intervention or treatment

    DRUG: TPX-0005

    DRUG: Metformin Hydrochloride

    DRUG: Digoxin

    DRUG: Rosuvastatin Calcium

    Conditions

    • Advanced Solid Tumor
    • Metastatic Solid Tumor
    Image related to Advanced 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.

    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

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    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/ArmIntervention/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 MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Area under plasma-concentration time curveAUC0-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 ConcentrationCmax: maximum observed plasma concentrationWithin 28 days of first cocktail dose

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Evaluate safety and tolerabilityTo 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 v5.0Within 28 days of first cocktail dose

    Frequently Asked Questions

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    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

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