NCT04229615

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
690

participants targeted

Target at P75+ for phase_3 ovarian-cancer

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

June 2, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

3.1 years

First QC Date

January 12, 2020

Last Update Submit

April 22, 2022

Conditions

Ovarian CancerFallopian Tube CancerPrimary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (2)

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

    Incidence of ≥3 grade treatment related adverse events

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

  • (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

    up to 4 years

Secondary Outcomes (6)

  • AEs+SAEs

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

  • PFS by investigator's assessment

    up to 4 years

  • OS

    up to 6 years

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

    48 months

  • Patients reported outcome（PROs）assessed by FOSI questionnaire

    48 months

  • +1 more secondary outcomes

Study Arms (3)

Safety Lead-in, Doublet Arm

EXPERIMENTAL

Fluzoparib+Apatinib

Drug: Fluzoparib; Apatinib

Single Arm

EXPERIMENTAL

Fluzoparib

Drug: Fluzoparib

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Fluzoparib; ApatinibDRUG

Drug: Fluzoparib Orally twice daily; Apatinib Orally once daily

Safety Lead-in, Doublet Arm
FluzoparibDRUG

Fluzoparib Orally twice daily

Single Arm
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • （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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Interventions

fluzoparibapatinib

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2020

First Posted

January 18, 2020

Study Start

June 2, 2020

Primary Completion

June 30, 2023

Study Completion

April 1, 2024

Last Updated

April 25, 2022

Record last verified: 2022-04

Locations

CN(1)