A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04517357
Collaborator
(none)
142
1
3
16.5
8.6

Study Details

Study Description

Brief Summary

This is a multicenter, randomized, open-label, 2-arm Phase 2 study to evaluate the efficacy and safety of Fluzoparib with Apatinib versus Fluzoparib alone, as treatment, in relapsed ovarian cancer patients. The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 2 portion of the study.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
142 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in the Treatment of Relapsed Ovarian Cancer Patients
Actual Study Start Date :
Oct 16, 2020
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Safety Lead-in or Parallel, Fluzoparib+Apatinib

Participants will receive Fluzoparib-Apatinib combination until progression

Drug: Fluzoparib+Apatinib
Fluzoparib-Apatinib combination

Active Comparator: Fluzoparib monotherapy

Participants will receive Fluzoparib monotherapy until progression

Drug: Fluzoparib
Fluzoparib monotherapy

Other: Exploratory cohort: Fluzoparib+Apatinib

Participants who has previously received PARP inhibitor, will receive Fluzoparib-Apatinib combination until progression

Drug: Fluzoparib+Apatinib
Fluzoparib-Apatinib combination

Outcome Measures

Primary Outcome Measures

  1. (Safety Lead-in) dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle [up to 28 days]

  2. (Safety Lead-in) Recommended Phase II Dose (RP2D) of Fluzoparib+Apatinib [up to 28 days]

  3. (Phase 2) Objective response rate(ORR) in relapsed ovarian cancer patients [Assessed up to a maximum of 20 months]

    Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment

  4. (Exploratory research) Objective response rate(ORR) in relapsed ovarian cancer patients [Assessed up to a maximum of 20 months]

    Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment

Secondary Outcome Measures

  1. AEs+SAEs [from the first drug administration to within 30 days for the last treatment dose]

    Adverse Events and Serious Adverse Events

  2. Progression free survival (PFS) [up to 20 months]

    Defined as Progression free survival per RECIST 1.1 criteria according to Investigator's assessment

  3. Disease control rate (DCR) [up to 20 months]

    Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1

  4. Duration of response (DoR) [up to 20 months]

    Time from documentation of tumor response to disease progression assessed among patients who had an objective response

  5. Response rate by RECIST 1.1 criteria [up to 20 months]

  6. Response rate by GCIG CA125 [up to 20 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Histologically diagnosed high-grade serous or endometrioid recurrent ovarian,fallopian tube,or peritoneal cancer.

  2. Patients must have received at least 2 previous platinum-containing regimens.

  3. At least one target lesion.

  4. ECOG performance status 0-1.

  5. Adequate bone marrow, kidney and liver function.

Exclusion Criteria:
  1. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib.For exploratory cohort ,patients who received PARP inhibitor are eligible;

  2. Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix allowed;

  3. Radiation or anti-hormonal therapy or anticancer therapy within 14 days before first administration;

  4. Known to be human immunodeficiency virus positive;

  5. Known active hepatitis C virus, or known active hepatitis B virus;

  6. Untreated and/or uncontrolled brain metastases;

  7. Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 3 months prior to the first administration;

  8. Pregnant or breast-feeding women.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhejiang Cancer Hospital Hangzhou Zhejiang China 310000

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04517357
Other Study ID Numbers:
  • FZPL-II-201
First Posted:
Aug 18, 2020
Last Update Posted:
Oct 29, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 29, 2021