WithdrawnPhase 1

A Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Repotrectinib in Advanced Cancer Patients

Stopped: Insufficient enrollment

United States, Spain0Started 2022-07-28

Plain-language summary

This is a Phase 1 study to evaluate the effect of moderate or severe hepatic impairment on the PK of repotrectinib in patients with advanced cancer.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor for which standard curative or palliative measures do not exist or are no longer effective. In case of hepatocellular carcinoma, the diagnosis should be based on at least 1 of the following:
✓. The presence of at least 1 lesion, measuring ≥2 cm, with characteristic arterial enhancement and venous washout in the setting of liver cirrhosis and/or hepatitis B or C infection.
✓. The presence of liver lesion(s) (as defined in inclusion criteria 3a) with alphafetoprotein ≥ 400 ng/mL.
✓. Tissue confirmation.
✓. For patients with genetic ROS1 or NTRK 1-3 gene fusion, tissue-based local testing should be documented.
✓. Biliary obstruction for whom a biliary drain or stent has been placed are eligible.
✓. Eastern Cooperative Oncology Group Performance Status scores 0 to 2.
✓. The patient must have no clinically significant change in hepatic disease status within the last 30 days before screening.

Area under the plasma concentration-time curve (AUC) of repotrectinib

Timeframe: Within 22 days of first repotrectinib dose

Maximum Observed Plasma Concentration (Cmax) of repotrectinib

Timeframe: Within 22 days of first Repotrectinib dose

NCT IDNCT05828277

SponsorTurning Point Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-31

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor for which standard curative or palliative measures do not exist or are no longer effective. In case of hepatocellular carcinoma, the diagnosis should be based on at least 1 of the following:
✓. The presence of at least 1 lesion, measuring ≥2 cm, with characteristic arterial enhancement and venous washout in the setting of liver cirrhosis and/or hepatitis B or C infection.
✓. The presence of liver lesion(s) (as defined in inclusion criteria 3a) with alphafetoprotein ≥ 400 ng/mL.
✓. Tissue confirmation.
✓. For patients with genetic ROS1 or NTRK 1-3 gene fusion, tissue-based local testing should be documented.
✓. Biliary obstruction for whom a biliary drain or stent has been placed are eligible.
✓. Eastern Cooperative Oncology Group Performance Status scores 0 to 2.
✓. The patient must have no clinically significant change in hepatic disease status within the last 30 days before screening.