Phase 1
Completed N=4
Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-Pamiparib in Participants With Advanced Cancer
Source: ClinicalTrials.gov NCT03991494 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcomePrimary: Plasma Pamiparib Pharmacokinetics: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞) — 29300 hours*nanograms/milliLiter (h*ng/mL)
Summary
This is an open-label study, in participants with advanced and/or metastatic solid tumors, which consists of 2 parts: a research phase (inpatient) and a treatment phase. The research phase (Part 1) of the study will assess the disposition of a single oral dose of [14C]-pamiparib. In the treatment phase (Part 2) participants will be allowed to have continued access to pamiparib.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Pamiparib Pharmacokinetics: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞) |
29300 | — |
| PRIMARY Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to Infinity (AUC0-∞) |
42200; 32200 | — |
| PRIMARY Plasma Pamiparib Pharmacokinetics: AUC From Time Zero to the Last Quantifiable Concentration (AUC0-t) |
29200 | — |
| PRIMARY Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to the Last Quantifiable Concentration (AUC-t) |
41800; 31200 | — |
| PRIMARY Plasma Pamiparib Pharmacokinetics: Maximum Observed Concentration (Cmax) of Pamiparib |
2190 | — |
| PRIMARY Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: Maximum Observed Concentration (Cmax) |
2390; 1730 | — |
| PRIMARY Plasma Pamiparib Pharmacokinetics: Time of Cmax (Tmax) |
2.00 | — |
| PRIMARY Plasma Total Radioactivity Whole Blood Total Radioactivity Pharmacokinetics: Time of Cmax (Tmax) |
2.25; 2.25 | — |
| PRIMARY Plasma Pamiparib Pharmacokinetics: Apparent Terminal Elimination Half-Life (t1/2) |
29.2 | — |
| PRIMARY Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: Apparent Terminal Elimination Half-Life (t1/2) |
21.6; 13.3 | — |
| PRIMARY Plasma Pamiparib Pharmacokinetics: Apparent Total Clearance (CL/F) |
2.21 | — |
| PRIMARY Plasma Pamiparib Pharmacokinetics: Apparent Volume of Distribution (Vz/F) |
91.3 | — |
| PRIMARY Plasma Pamiparib Pharmacokinetics: AUC0-∞ of Plasma Pamiparib Relative to AUC0-∞ of Plasma Total Radioactivity |
0.694 | — |
| PRIMARY Plasma Pharmacokinetics: AUC0-∞ of Whole Blood Total Radioactivity to AUC0-∞ of Plasma Total Radioactivity |
0.764 | — |
| PRIMARY Percentage of Total Radioactivity Excreted in Urine |
57.84 | — |
| PRIMARY Cumulative Urinary Excretion of Pamiparib |
1.095 | — |
| PRIMARY Renal Clearance of Pamiparib (CLR) |
0.03742 | — |
| PRIMARY Fecal Recovery of Total Radioactivity |
26.89 | — |
| PRIMARY Cumulative Recovery of Total Radioactivity in Total Excreta |
84.73 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events in Part1 and Part 2 |
4; 0; 3; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Abnormalities |
— | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in 12-lead ECG Parameters, Vital Signs Data, Physical Examinations and Weight Data |
— | — |
| SECONDARY Pamiparib Metabolite Identified and Metabolic Profile Using Measured Mass (M3) |
313.1098 | — |
Eligibility Criteria
Key Inclusion Criteria
- Histologically and/or cytologically confirmed advanced or metastatic solid tumor that has progressed after treatment with approved therapies for which there are no standard therapies available
- A total body weight between 50 and 100 kg, inclusive at Screening
- Measurable disease by CT/MRI
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
- Adequate organ function
Key Exclusion Criteria
- Clinically significant cardiovascular disease
- Have a previous complete gastric resection, chronic diarrhea, active inflammatory gastrointestinal disease, or any other disease causing malabsorption syndrome.
- Poor peripheral venous access
- Major surgical procedure, open biopsy, or significant traumatic injury ≤ 2 weeks prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
- Use or have anticipated need for food or drugs known to be strong or moderate CYP3A inhibitors or strong CYP3A inducers
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03991494). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.