Treatment of Carrying TP53 Harmful Mutations

Sponsor
Tianjin Medical University Second Hospital
Study ID
NCT03645200
Phase
PHASE1
Status
Unknown

Conditions

  • Advanced Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Fluzoparib combined with Apatinib — DRUG
    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

Study Details

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

Key Dates

Start date
Jul 1, 2019
Status verified
Aug 2018
Primary completion
Dec 1, 2019
Completion
Jun 1, 2020

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Fluzoparib combined with Apatinib
    Fluzoparib in the initial dose of 40mg.bid started into the group of participants, group A combined with a fixed dose of Apatinib 250mg.qd for treatment, followed by the 40mg.bid, 60mg.bid, 80mg.bid, 100mg.bid dose increase. Fluzoparib in the initial dose of 40mg.bid started into the group of participants, Group B was treated with a fixed dose of Apatinib 500mg.qd, followed by an increase in doses of 40mg.bid, 60mg.bid, 80mg.bid, 100mg.bid .

Primary Outcome Measure

Dosage (provide right dosage for II phase clinical trial) [ Time Frame: 12 months ]

Central Contacts

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