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A Study of Fluzoparib±Apatinib Versus Placebo Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on First-Line Platinum-Based Chemotherapy

Primary Purpose

Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

Status

Active

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Fluzoparib; Apatinib

Fluzoparib

Placebo

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

（phase 3）Histologically new diagnosed, advanced (FIGO Stage III or IV) high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer)
（phase 3）Complete response (CR) or partial response (PR) achieved with front-line platinum-based chemotherapy regimen as determined by investigator
（phase 3）Ability to be randomized ≤8 weeks after last dose of platinum
（Saftey Lead-in）Received 2~4 prior chemotherapy regimens. Platimun sensitive relapsed; Have at least one measurable disease as defined by RECIST v1.1.

Exclusion Criteria:

Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib
Patients who have received other study drug treatment within 4 weeks prior to the first administration(< 5 elimination half-lives of the study drug molecular targeted anti-cancer drugs).
Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 2 months prior to the first administration.

Sites / Locations

Cancer Hospital Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Safety Lead-in, Doublet Arm

Single Arm

Placebo

Arm Description

Fluzoparib+Apatinib

Fluzoparib

Placebo

Outcomes

Primary Outcome Measures

(Safety Lead-in) Incidence of ≥3 grade TRAEs

Incidence of ≥3 grade treatment related adverse events

(Phase 3) Progression free survival(PFS) in advanced ovarian cancer patients

Defined as progression free survival per RECIST 1.1 criteria according to BIRC criteria

Secondary Outcome Measures

AEs+SAEs

Adverse Events and Serious Adverse Events

PFS by investigator's assessment

Progression-Free-Survival

OS is the time interval from the start of treatment to death due to any reason or lost of follow-up

Patients reported outcome（PROs）assessed by EQ-5D-5L questionnaire

Comparison of the Quality of Life in study arms assessed by EQ-5D-5L questionnaire

Patients reported outcome（PROs）assessed by FOSI questionnaire

Comparison of the Quality of Life in study arms assessed by FOSI questionnaire

Time to progression on the next anticancer therapy (PFS2) From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first.

From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first.

Full Information

NCT ID

NCT04229615

First Posted

January 12, 2020

Last Updated

April 22, 2022

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04229615

Brief Title

A Study of Fluzoparib±Apatinib Versus Placebo Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on First-Line Platinum-Based Chemotherapy

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase III Clinical Trial Evaluating the Efficacy and Safety of Fluzoparib±Apatinib for Maintenance Treatment in Patients With Advanced Ovarian Cancer Who Have Achieved Effective Response After First-line Platinum-containing Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 2, 2020 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a multicenter, randomized, blinded, 3-arm Phase 3 study to evaluate the efficacy and safety of Fluzoparib alone or with Apatinib versus Placebo, as maintenance treatment, in patients with Stage III or IV ovarian cancer. Patients must have completed first-line platinum based regimen with Complete Response (CR) or Partial Response (PR). The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 3 portion of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

690 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Safety Lead-in, Doublet Arm

Arm Type

Experimental

Arm Description

Fluzoparib+Apatinib

Arm Title

Single Arm

Arm Type

Experimental

Arm Description

Fluzoparib

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Fluzoparib; Apatinib

Intervention Description

Drug: Fluzoparib Orally twice daily; Apatinib Orally once daily

Intervention Type

Drug

Intervention Name(s)

Fluzoparib

Intervention Description

Fluzoparib Orally twice daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

(Safety Lead-in) Incidence of ≥3 grade TRAEs

Description

Incidence of ≥3 grade treatment related adverse events

Time Frame

up to 28 days after the last patient of the lead-in phase

Title

(Phase 3) Progression free survival(PFS) in advanced ovarian cancer patients

Description

Defined as progression free survival per RECIST 1.1 criteria according to BIRC criteria

Time Frame

up to 4 years

Secondary Outcome Measure Information:

Title

AEs+SAEs

Description

Adverse Events and Serious Adverse Events

Time Frame

from the first drug administration to within 30 days for the last treatment dose

Title

PFS by investigator's assessment

Description

Progression-Free-Survival

Time Frame

up to 4 years

Title

Description

OS is the time interval from the start of treatment to death due to any reason or lost of follow-up

Time Frame

up to 6 years

Title

Patients reported outcome（PROs）assessed by EQ-5D-5L questionnaire

Description

Comparison of the Quality of Life in study arms assessed by EQ-5D-5L questionnaire

Time Frame

48 months

Title

Patients reported outcome（PROs）assessed by FOSI questionnaire

Description

Comparison of the Quality of Life in study arms assessed by FOSI questionnaire

Time Frame

48 months

Title

Time to progression on the next anticancer therapy (PFS2) From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first.

Description

From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first.

Time Frame

4 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: （phase 3）Histologically new diagnosed, advanced (FIGO Stage III or IV) high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer) （phase 3）Complete response (CR) or partial response (PR) achieved with front-line platinum-based chemotherapy regimen as determined by investigator （phase 3）Ability to be randomized ≤8 weeks after last dose of platinum （Saftey Lead-in）Received 2~4 prior chemotherapy regimens. Platimun sensitive relapsed; Have at least one measurable disease as defined by RECIST v1.1. Exclusion Criteria: Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib Patients who have received other study drug treatment within 4 weeks prior to the first administration(< 5 elimination half-lives of the study drug molecular targeted anti-cancer drugs). Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 2 months prior to the first administration.

Facility Information:

Facility Name

Cancer Hospital Chinese Academy of Medical Sciences

City

Beijing

State/Province

Beijing

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

A Study of Fluzoparib±Apatinib Versus Placebo Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on First-Line Platinum-Based Chemotherapy

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