NCT04000295

Brief Summary

The study is conducted to evaluate the efficacy, safety and tolerability of apatinib (375 mg qd) and etoposide capsule (50 mg/d, d1-14, q3w) in subjects with platinum resistant or refractory ovarian cancer compared with weekly paclitaxel (80 mg/m2, d1, d8, d15, q3w).

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
280

participants targeted

Target at P25-P50 for phase_3 ovarian-cancer

Timeline
Completed

Started Aug 2019

Shorter than P25 for phase_3 ovarian-cancer

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

June 24, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 27, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 16, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

October 8, 2019

Status Verified

June 1, 2019

Enrollment Period

1.4 years

First QC Date

June 24, 2019

Last Update Submit

October 7, 2019

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression free survival(PFS) by independent review committee(IRC)

    PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the IRC according to the RECIST criteria

    up to approximately 2 years

Secondary Outcomes (6)

  • The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    up to approximately 2 years

  • PFS by investigator

    up to approximately 2 years

  • Objective Response Rate (ORR)

    up to approximately 2 years

  • Overall Survival (OS)

    up to approximately 3 years

  • EQ-5D-5L questionnaire

    up to approximately 2 years

  • +1 more secondary outcomes

Study Arms (2)

Apatinib and Etoposide capsule

EXPERIMENTAL

Apatinib (375 mg qd, q3w) and Etoposide capsule(50 mg/d, d1-14, q3w) combination until disease progression or intolerable toxicity

Drug: ApatinibDrug: Etoposide

Weekly Paclitaxel

ACTIVE COMPARATOR

Weekly Paclitaxel (80 mg/m2, d1, d8, d15, q3w) until disease progression or intolerable toxicity

Drug: Paclitaxel

Interventions

ApatinibDRUG

Subjects receive Apatinib orally, Dosage form: tablet, Strength: 375 mg/d

Apatinib and Etoposide capsule
EtoposideDRUG

Subjects receive Etoposide capsule orally, d1-14, q3w, Dosage form: capsule, Strength: 50 mg/d

Apatinib and Etoposide capsule
PaclitaxelDRUG

Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, q3w, Dosage form: injectable, Strength: 80 mg/m2

Weekly Paclitaxel

Eligibility Criteria

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

You may qualify if:

  • Years and older
  • Epithelial ovarian, fallopian tube or primary peritoneal cancer
  • Platinum refractory and resistant disease (disease progression during platinum therapy or within 6 months of platinum therapy)
  • EOCG performance status of 0-1

You may not qualify if:

  • Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)
  • Known hypersensitivity to any of the study drugs or excipients.
  • Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
  • Congenital or acquired immune deficiency (e.g. HIV infected)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

apatinibEtoposidePaclitaxel

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

Intervention Hierarchy (Ancestors)

PodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenes

Central Study Contacts

Zhaoyu Zhong, M.M

CONTACT

+86 15045090779zhongzhaoyu@hrglobe.cn

Lanjun Zhao, Ph.D

CONTACT

+86 13331180196zhaolanjun@hrglobe.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2019

First Posted

June 27, 2019

Study Start

August 16, 2019

Primary Completion

January 1, 2021

Study Completion

July 1, 2022

Last Updated

October 8, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

All clinical study findings and documents will be regarded as confidential. The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor.

Locations

CN(1)