An Open-Label Pharmacokinetics and Safety Study of Talazoparib

Official Title

A Phase I Open-label Pharmacokinetics And Safety Study Of Talazoparib (mdv3800) In Patients With Advanced Solid Tumours And Normal Or Varying Degrees Of Renal Impairment

Summary:

This trial will investigate the pharmacokinetics (PK) and safety of talazoparib in patients with advanced solid tumours and impaired renal function.

Trial Description

Primary Outcome:

  • Pharmacokinetics of talazoparib as assessed by trough plasma concentrations
Secondary Outcome:
  • Safety as assessed by percentage of patients with any Adverse Event (AE), AE leading to Study Drug Discontinuation, AE leading to death, Serious Adverse Event (SAE), AE related to study drug, SAE related to study drug.
At the End of the Study, patients with no clinically significant toxicities, no contraindications to continue treatment with talazoparib, and no disease progression (underlying cancer progression) may be eligible to continue talazoparib treatment in a separate open-label extension study after discussion with the Principal Investigator and obtaining Sponsor permission. Sponsor decision to allow the patient to continue dosing with talazoparib in an open-label extension study will be based on potential overall benefit-risk, patient acceptance and other relevant criteria.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society