A Study of Fluzoparib Combined With Apatinib as Second-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer（FA-ES-SCLC）

Sponsor
Tianjin Medical University Second Hospital
Study ID
NCT04659785
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Small Cell Lung Cancer Extensive Stage

Eligibility Criteria

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

Interventions

  • Fluzoparib — DRUG
    Take Fluzoparib orally（either at 50,100mg bid）until disease progression or appearance of unbearable toxicity
  • Apatinib — DRUG
    Take apatinib orally (either at 375mg、500mg、750mg qd）until disease progression or appearance of unbearable toxicity

Study Details

This open-label, dose finding phase Ib trial studies the tolerability and the best dose of fluzoparib in combination with apatinib and to see how well these two drugs work together as second-line treatment of patients with extensive stage small cell lung cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored. Both dose escalation and dose expansion parts are included in this study.

Key Dates

Start date
Jul 1, 2020
Status verified
Dec 2020
Primary completion
Jul 31, 2021
Completion
Dec 31, 2022

Study Design

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

Arms

  • Experimental: Fluzoparib + Apatinib
    Fluzoparib and apatinib will be administered continuously and orally in combination, 28 days per cycle, until disease progression or unacceptable toxicity.

Primary Outcome Measure

Phase Ⅰb: Determination of Recommended Phase II dose (RP2D) of Escalating Dose of Fluzoparib with Apatinib [ Time Frame: Up to 28 days after the first dose of Fluzoparib and Apatinib combination therapy ]

Central Contacts

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