Adults 13 Months to 30, any sex, with Adult Solid Neoplasm or Childhood Solid Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Number of Participants With Dose Limiting Toxicities to Determine the Maximum Tolerated Dose of Temozolomide and Talazoparib Combination TherapyPrimary· 28 days
The Maximum Tolerated Dose (MTD) reflects the highest dose of Talazoparib (BMN 673) when combined with a dose of temozolomide that did not cause a Grade 3 or higher toxicity in children with refractory or recurrent solid tumors.
T Max of TalazoparibPrimary· Cycle 1 Day 1 pre-dose, and 1, 2, 4, 8 and 24 hours after the first talazoparib dose.
Median with minimum and maximum for the time at which the maximum (peak) serum concentration occurs.
Group
Value
95% CI
Treatment (Talazoparib, Temozolomide): Phase 1
2
1 – 24
C Max of TalazoparibPrimary· Cycle 1 Day 1 pre-dose, and 1, 2, 4, 8 and 24 hours after the first talazoparib dose.
Median with minimum and maximum for the time at which the maximum (peak) serum concentration occurs.
Group
Value
95% CI
Treatment (Talazoparib, Temozolomide): Phase 1
4670
708 – 19300
AUC of TalazoparibPrimary· Cycle 1 Day 1 pre-dose, and 1, 2, 4 and 8 hours after the first talazoparib dose
Median with minimum and maximum for the area under the drug concentration over time curve.
Group
Value
95% CI
Treatment (Talazoparib, Temozolomide): Phase 1
17.55
2.15 – 63.14
Accumulation Half-life of Talazoparib in Combination With Temozolomide.Primary· Cycle 1 Day 1 pre-dose, and 1, 2, 4 and 8 hours after the first talazoparib dose. Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the talazoparib dose
Median with minimum and maximum for the time required for the serum concentration to fall to 50% of its starting dose.
Group
Value
95% CI
Treatment (Talazoparib, Temozolomide): Phase 1
46.8
18.20 – 253.27
T Max of Talazoparib in Combination With TemozolomidePrimary· Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the talazoparib dose
Median with minimum and maximum for the time at which the maximum (peak) serum concentration occurs.
Group
Value
95% CI
Treatment (Talazoparib, Temozolomide): Phase 1
1.04
1 – 8
C Max of Talazoparib in Combination With TemozolomidePrimary· Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the talazoparib dose
Median with minimum and maximum for the time at which the maximum (peak) serum concentration occurs.
Group
Value
95% CI
Treatment (Talazoparib, Temozolomide): Phase 1
16450
7070 – 56300
AUC of Talazoparib in Combination With TemozolomidePrimary· Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the talazoparib dose
Median with minimum and maximum area under the drug concentration over time curve
Group
Value
95% CI
Treatment (Talazoparib, Temozolomide): Phase 1
82.08
41.92 – 226.70
AUC of Talazoparib in Combination With TemozolomidePrimary· Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the talazoparib dose
Median with minimum and maximum area under the drug concentration over time curve
Group
Value
95% CI
Treatment (Talazoparib, Temozolomide): Phase 1
173.08
83.61 – 456.28
Clearance of Talazoparib in Combination With TemozolomidePrimary· Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the talazoparib dose
Median with minimum and maximum for the rate of elimination of the drug.
Group
Value
95% CI
Treatment (Talazoparib, Temozolomide): Phase 1
3.08
1.34 – 6.19
Accumulation Ratio of Talazoparib in Combination With TemozolomidePrimary· Cycle 1 Day 1 pre-dose, and 1, 2, 4 and 8 hours after the first talazoparib dose. Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the talazoparib dose
Median with minimum and maximum of the accumulation ratio.
Group
Value
95% CI
Treatment (Talazoparib, Temozolomide): Phase 1
3.34
1.67 – 15.73
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 24 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase I/II trial studies the side effects and best dose of talazoparib and temozolomide and to see how well they work in treating younger patients with tumors that have not responded to previous treatment (refractory) or have come back (recurrent). Talazoparib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving talazoparib together with temozolomide may work better in treating younger patients with refractory or recurrent malignancies.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 26 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02116777.