NCT03645200

Treatment of Carrying TP53 Harmful Mutations

Fluzoparib Combined With Apatinib for the Treatment of Carrying TP53 Harmful Mutations in Advanced Refractory Solid Tumors of the I Stage Clinical Study

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tianjin Medical University Second Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Assessment of the safety and tolerability of Fluzoparib combined with Apatinib in the treatment of advanced refractory solid tumors with TP53 harmful mutations.

Detailed description

Results of the clinical trial of the combination of Fluzoparib and Apatinib in the treatment of gastric cancer animal model and the drug PARP inhibitor alone, PARP inhibitor combined with VEGFR inhibitor, Patients with advanced refractory solid tumors with TP53 harmful mutations can be expected to be safe and effective in the treatment of Fluzoparib and Apatinib.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
DRUG	Fluzoparib combined with Apatinib	Fluzoparib : 40mg.bid, morning and evening each time, interval of 12 hours or so, the first oral administration 72 hours later Apatinib : 250mg or 500mg take one day, 72 hours later, the continuous drug delivery phase (B-C1D1) was entered into the Fluzoparib, that is, the Fluzoparib capsule with 40mg.bid, every morning and evening, each time, interval of 12 hours, the Apatinib tablets daily with the Fluzoparib capsule with the same service, fixed doses of 250mg or 500mg, daily. Continuous drug delivery for 28 days for one cycle

Timeline

• Start date: 2019-07-01
• Primary completion: 2019-12-01
• Completion: 2020-06-01
• First posted: 2018-08-24
• Last updated: 2019-04-25

Locations

1 site across 1 country: China