NCT04383977

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P50-P75 for phase_2 ovarian-cancer

Timeline
Completed

Started May 2020

Shorter than P25 for phase_2 ovarian-cancer

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

Study Start

First participant enrolled

May 1, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

May 6, 2020

Last Update Submit

May 9, 2020

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR) by investigator

    ORR was defined as the proportion of subjects who have a complete or partial response relative to baseline .

    up to 2 years

Secondary Outcomes (7)

  • AEs+SAEs

    30 days after the last dose

  • PFS by investigator

    up to 2 years

  • Overall Survival (OS)

    up to 3 years

  • Pharmacokinetic characteristic

    up to 2 years

  • Pharmacokinetic characteristic

    up to 2 years

  • +2 more secondary outcomes

Study Arms (2)

Apatinib-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: Apatinib and Etoposide capsule

Apatinib

ACTIVE COMPARATOR

Apatinib (375 mg qd, q3w) until disease progression or intolerable toxicity

Drug: Apatinib

Interventions

Apatinib and Etoposide capsuleDRUG

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

Apatinib-Etoposide capsule
ApatinibDRUG

Apatinib (375 mg qd, q3w) until disease progression or intolerable toxicity

Apatinib

Eligibility Criteria

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

You may qualify if:

  • Female patients, ≥18 Years.
  • 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 0-2

You may not qualify if:

  • Non-epithelial tumours
  • Ovarian tumours with low malignant potential
  • Surgery (including open biopsy) within 4 weeks before starting study therapy or anticipated need for major surgery during study treatment
  • Evidence of rectosigmoid involvement by pelvic examination, bowel involvement on computed tomography, or clinical symptoms of bowel obstruction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hou Z, Lan C, Huang X, Salcedo-Hernandez RA, El-Tawab S. Efficacy, safety and pharmacokinetics of apatinib plus etoposide versus apatinib alone for platinum-resistant recurrent ovarian cancer: protocol of a multicenter, open-label, randomized phase 2 trial. Transl Cancer Res. 2023 Oct 31;12(10):2959-2967. doi: 10.21037/tcr-23-1924. Epub 2023 Oct 26.

    PMID: 37969395DERIVED

Related Links

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

apatinibEtoposide

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 CompoundsGlucosidesGlycosidesCarbohydrates

Central Study Contacts

Zhaoyu Zhong, M.M

CONTACT

+86 15045090779zhongzhaoyu@hrglobe.cn

Fenglin She, M.M

CONTACT

+86 18301190515shefenglin@hrglobe.cn

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

May 6, 2020

First Posted

May 12, 2020

Study Start

May 1, 2020

Primary Completion

December 1, 2020

Study Completion

June 1, 2021

Last Updated

May 12, 2020

Record last verified: 2020-05

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.