CompletedPhase 1

An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800)

United States38 participantsStarted 2016-09-30

Plain-language summary

This is a trial to investigate the pharmacokinetics (PK) and the safety of talazoparib in patients with advanced solid tumors and impaired hepatic function.

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.

Inclusion criteria

✓. Signed and dated Informed Consent Form (by the patient or a legally acceptable representative as per the local regulations).
✓. Female or male at least 18 years of age.
✓. Histologically or cytologically confirmed advanced solid tumor with no available standard treatment options in the opinion of the Investigator
✓. Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.
✓. Expected life expectancy of ≥ 3 months.
✓. Able to swallow the study drug (no contraindication to oral agents).
✓. Hepatic function at screening and enrollment as defined by the NCI organ dysfunction working group (NCI-ODWG) criteria.
✓. Adequate other organ function at screening and enrollment.

Exclusion criteria

✕. Treatment within 14 days or five half lives prior to enrollment whichever is longer with any type of systemic anticancer-therapy or any investigational drug
✕. Have not recovered (recovery is defined as CTCAE grade ≤ 1) from the acute toxicities of previous anticancer standard or investigational therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
✕. Major surgery within 28 days prior to enrollment.
✕. Serious accompanying cardiac disorder
✕. Active known or suspected brain metastasis or active leptomeningeal disease needing treatment
✕. Symptomatic or impending spinal cord compression or cauda equine syndrome
✕. Has undergone a liver transplant, kidney transplant or nephrectomy.
✕. Prior allergic reaction or severe intolerance (meeting the criteria for a serious adverse event, a grade 3 or 4 AE, or permanent treatment discontinuation) to a poly ADP ribose polymerase (PARP) inhibitor.

What they're measuring

Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24) of Talazoparib on Day 22

Timeframe: Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22

Maximum Observed Plasma Concentration (Cmax) of Talazoparib on Day 22

Timeframe: Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22

Unbound Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24u) of Talazoparib on Day 22

Timeframe: Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22

Unbound Maximum Observed Plasma Concentration (Cmaxu) of Talazoparib on Day 22

Timeframe: Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22

Trial details

NCT IDNCT02997176

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-02-12

Results submitted2021-02-05

View on ClinicalTrials.gov More Advanced Solid Tumors trials

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.

Inclusion criteria

✓. Signed and dated Informed Consent Form (by the patient or a legally acceptable representative as per the local regulations).
✓. Female or male at least 18 years of age.
✓. Histologically or cytologically confirmed advanced solid tumor with no available standard treatment options in the opinion of the Investigator
✓. Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.
✓. Expected life expectancy of ≥ 3 months.
✓. Able to swallow the study drug (no contraindication to oral agents).
✓. Hepatic function at screening and enrollment as defined by the NCI organ dysfunction working group (NCI-ODWG) criteria.
✓. Adequate other organ function at screening and enrollment.

Exclusion criteria

✕. Treatment within 14 days or five half lives prior to enrollment whichever is longer with any type of systemic anticancer-therapy or any investigational drug
✕. Have not recovered (recovery is defined as CTCAE grade ≤ 1) from the acute toxicities of previous anticancer standard or investigational therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
✕. Major surgery within 28 days prior to enrollment.
✕. Serious accompanying cardiac disorder
✕. Active known or suspected brain metastasis or active leptomeningeal disease needing treatment
✕. Symptomatic or impending spinal cord compression or cauda equine syndrome
✕. Has undergone a liver transplant, kidney transplant or nephrectomy.
✕. Prior allergic reaction or severe intolerance (meeting the criteria for a serious adverse event, a grade 3 or 4 AE, or permanent treatment discontinuation) to a poly ADP ribose polymerase (PARP) inhibitor.