Phase 1
Completed N=15
STUDY OF TALAZOPARIB MONOTHERAPY IN CHINESE PARTICIPANTS WITH ADVANCED SOLID TUMORS
Source: ClinicalTrials.gov NCT04635631 ↗Enrolled (actual)
15
Serious AEs
20.0%
Results posted
Oct 2023
Primary outcomePrimary: Maximum Observed Concentration (Cmax) of Talazoparib Following Single Oral Dose — 8.506 nanogram/milliliter (ng/mL)
Summary
A phase1 study to evaluate the PK (single dose and multiple doses) and safety of talazoparib 1 mg Once Daily in Chinese adult participants with advanced solid tumors. A maximum of approximately 15 participants will be enrolled such that approximately 12 evaluable participants complete the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Concentration (Cmax) of Talazoparib Following Single Oral Dose |
8.506 | — |
| PRIMARY Time to Cmax (Tmax) of Talazoparib Following Single Oral Dose |
1.90 | — |
| PRIMARY Area Under Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Talazoparib Following Single Oral Dose |
172.0 | — |
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of Talazoparib Following Single Oral Dose |
86.54 | — |
| PRIMARY Apparent Oral Clearance (CL/F) of Talazoparib Following Single Oral Dose |
4.798 | — |
| PRIMARY Apparent Volume of Distribution (Vz/F) of Talazoparib Following Single Oral Dose |
456.8 | — |
| PRIMARY Terminal Half-Life (t1/2) of Talazoparib Following Single Oral Dose |
67.00 | — |
| PRIMARY Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Talazoparib Following Single Oral Dose |
208.3 | — |
| PRIMARY Cmax of Talazoparib Following Multiple Oral Doses (Steady State) |
14.35 | — |
| PRIMARY Tmax of Talazoparib Following Multiple Oral Doses (Steady State) |
1.85 | — |
| PRIMARY Minimum Plasma Concentration (Cmin) of Talazoparib Following Multiple Oral Doses (Steady State) |
2.616 | — |
| PRIMARY AUCtau of Talazoparib Following Multiple Oral Doses (Steady State) |
147.8 | — |
| PRIMARY CL/F of Talazoparib Following Multiple Oral Doses (Steady State) |
6.770 | — |
| PRIMARY Observed Accumulation Ratio (Rac) of Talazoparib Following Multiple Oral Doses (Steady State) |
1.733 | — |
| PRIMARY Steady-State Accumulation Ratio (Rss) of Talazoparib Following Multiple Oral Doses (Steady State) |
0.6958 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
14; 13; 10; 6; 0; 3 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
3; 3 | — |
| SECONDARY Number of Participants With Grade 3 or 4 All-Causality TEAEs by Preferred Term (PT) and Maximum CTCAE Grade |
3; 1; 4; 3; 1; 1 | — |
| SECONDARY Number of Participants With Grade 3 or 4 Treatment-Related TEAEs by PT and Maximum CTCAE Grade |
4; 3; 1; 1; 2; 1 | — |
| SECONDARY Number of Participants With TEAEs Leading to Dose Interruption of Talazoparib by PT |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Number of Participants With TEAEs Leading to Dose Reduction of Talazoparib by PT |
3; 3; 3; 3; 3; 3 | — |
| SECONDARY Number of Participants With TEAEs Leading to Discontinuation From Talazoparib by PT |
1; 1 | — |
| SECONDARY Number of Participants With On-Treatment Hematology Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade |
3; 1; 1; 5; 1; 1 | — |
| SECONDARY Number of Participants With On-Treatment Chemistry Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade |
1; 2; 1; 1; 1; 1 | — |
| SECONDARY Number of Participants With On-Treatment Urinalysis Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade |
0; 0; 0 | — |
| SECONDARY Number of Participants With On-Treatment Vital Signs Data Meeting Pre-Specified Criteria for Potentially Clinically Significant Results |
1 | — |
| SECONDARY Number of Participants With On-Treatment Maximum QT Interval (Bazett's Correction) (QTcB) and QT Interval (Fridericia's Correction) (QTcF) Data by Category |
9; 5; 0; 1; 14; 1 | — |
| SECONDARY Number of Participants With On-Treatment Maximum Increase From Baseline in QTcB and QTcF Data by Category |
9; 2; 4; 9; 3; 3 | — |
| SECONDARY Number of Participants With On-Treatment Concomitant Medications |
14 | — |
| SECONDARY Number of Participants With On-Treatment Concomitant Medications With Frequency >=20% by PT |
3; 3; 3; 3; 3; 3 | — |
| SECONDARY Number of Participants With On-Treatment Concomitant Nondrug Treatments/Procedures |
5 | — |
| SECONDARY Number of Participants With On-Treatment Concomitant Nondrug Treatments/Procedures by PT |
2; 1; 1; 1; 1; 1 | — |
| SECONDARY Percentage of Participants Achieving Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) (Confirmed or Unconfirmed) |
6.7 | — |
| SECONDARY Duration of Response (DOR) for Participant(s) Achieving CR or PR |
172 | — |
Eligibility Criteria
Inclusion Criteria
- Histological or cytological diagnosis of locally advanced or metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available.
- ECOG Performance Status 0 or 1.
- Adequate Bone Marrow, Renal and Liver Function.
Exclusion Criteria
- Participants with brain metastases.
- Current or anticipated use of P gp inhibitor and/or inducer within 7 days prior to study intervention from lead-in to end of Cycle 1; concomitant use of potent P gp inhibitor after Cycle 1 until the end of treatment.
- Prior treatment with a PARP inhibitor.
Data sourced from ClinicalTrials.gov (NCT04635631). 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.