NCT04517357

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

August 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 16, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

3.1 years

First QC Date

August 16, 2020

Last Update Submit

February 21, 2025

Conditions

Relapsed Ovarian Cancer

Outcome Measures

Primary Outcomes (4)

  • (Safety Lead-in) dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle

    up to 28 days

  • (Safety Lead-in) Recommended Phase II Dose (RP2D) of Fluzoparib+Apatinib

    up to 28 days

  • (Phase 2) Objective response rate（ORR） in relapsed ovarian cancer patients

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

    Assessed up to a maximum of 20 months

  • (Exploratory research) Objective response rate（ORR） in relapsed ovarian cancer patients

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

    Assessed up to a maximum of 20 months

Secondary Outcomes (6)

  • AEs+SAEs

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

  • Progression free survival (PFS)

    up to 20 months

  • Disease control rate (DCR)

    up to 20 months

  • Duration of response (DoR)

    up to 20 months

  • Response rate by RECIST 1.1 criteria

    up to 20 months

  • +1 more secondary outcomes

Study Arms (3)

Safety Lead-in or Parallel， Fluzoparib+Apatinib

EXPERIMENTAL

Participants will receive Fluzoparib-Apatinib combination until progression

Drug: Fluzoparib+Apatinib

Fluzoparib monotherapy

ACTIVE COMPARATOR

Participants will receive Fluzoparib monotherapy until progression

Drug: Fluzoparib

Exploratory cohort: Fluzoparib+Apatinib

OTHER

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

Drug: Fluzoparib+Apatinib

Interventions

Fluzoparib+ApatinibDRUG

Fluzoparib-Apatinib combination

Safety Lead-in or Parallel， Fluzoparib+Apatinib
FluzoparibDRUG

Fluzoparib monotherapy

Fluzoparib monotherapy

Eligibility Criteria

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

You may qualify if:

  • Histologically diagnosed high-grade serous or endometrioid recurrent ovarian,fallopian tube,or peritoneal cancer.
  • Patients must have received at least 2 previous platinum-containing regimens.
  • At least one target lesion.
  • ECOG performance status 0-1.
  • Adequate bone marrow, kidney and liver function.

You may not qualify if:

  • Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib.For exploratory cohort ，patients who received PARP inhibitor are eligible;
  • 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;
  • Radiation or anti-hormonal therapy or anticancer therapy within 14 days before first administration;
  • Known to be human immunodeficiency virus positive;
  • Known active hepatitis C virus, or known active hepatitis B virus;
  • Untreated and/or uncontrolled brain metastases;
  • 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;
  • Pregnant or breast-feeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

fluzoparib

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 Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2020

First Posted

August 18, 2020

Study Start

October 16, 2020

Primary Completion

November 30, 2023

Study Completion

November 1, 2024

Last Updated

February 24, 2025

Record last verified: 2025-02

Locations

CN(1)