Ovarian CancerPhase 2NCT04383977
Apatinib and Etoposide Capsule Versus Apatinib in Patients With Platinum Resistant Ovarian Cancer
A Phase 2 study testing Apatinib and Etoposide capsule and Apatinib in people with Ovarian Cancer, run by Jiangsu HengRui Medicine Co., Ltd..
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Apatinib and Etoposide capsule and Apatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- May 2020to Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase 2 Randomized, Open-label, Multicenter Trial of Apatinib and Etoposide Capsule Versus Apatinib in Patients With Platinum Resistant or Refractory Ovarian Cancer
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).
- Conditions
- Ovarian Cancer
- Being tested
- Apatinib and Etoposide capsule, Apatinib
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
ApatinibDrug
Apatinib (375 mg qd, q3w) until disease progression or intolerable toxicity
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Apatinib and Etoposide capsule |
| Apatinib | Active comparator | Apatinib (375 mg qd, q3w) until disease progression or intolerable toxicity Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) by investigator
ORR was defined as the proportion of subjects who have a complete or partial response relative to baseline .
Measured: up to 2 years
Secondary outcomes (7)
AEs+SAEs
Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0
Measured: 30 days after the last dose
PFS by investigator
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 investigator according to the RECIST criteria.
Measured: up to 2 years
Overall Survival (OS)
OS is the time interval from the date of randomization to death from any cause.
Measured: up to 3 years
Pharmacokinetic characteristic
Evaluation of PK parameters Tmax of apatinib or etoposide in plasma
Measured: up to 2 years
Pharmacokinetic characteristic
Evaluation of PK parameters Cmax of apatinib or etoposide in plasma
Measured: up to 2 years
Pharmacokinetic characteristic
Evaluation of PK parameters t1/2 of apatinib or etoposide in plasma
Measured: up to 2 years
Pharmacokinetic characteristic
Evaluation of PK parameters AUC0-t of apatinib or etoposide in plasma
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study startMay 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383977
- Sponsor's protocol ID
- Ahead-OC-203
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 37969395
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Open-label, Multicenter Trial of Apatinib and Etoposide Capsule Versus Apatinib in Patients With Platinum Resistant or Refractory Ovarian Cancer
- ClinicalTrials.gov ID
- NCT04383977
- Acronym / sponsor ID
- Ahead-OC-203
- Conditions
- Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apatinib-Etoposide capsule | Experimental | Drug: Apatinib and Etoposide capsuleApatinib (375 mg qd, q3w) and Etoposide capsule(50 mg/d, d1-14, q3w) combination until disease progression or intolerable toxicity |
| Apatinib | Active comparator | Drug: ApatinibApatinib (375 mg qd, q3w) until disease progression or intolerable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apatinib and Etoposide capsuleApatinib (375 mg qd, q3w) and Etoposide capsule(50 mg/d, d1-14, q3w) combination until disease progression or intolerable toxicity | Drug | Apatinib-Etoposide capsule |
| ApatinibApatinib (375 mg qd, q3w) until disease progression or intolerable toxicity | Drug | Apatinib |
Primary outcome
Objective response rate (ORR) by investigator
Time frame: up to 2 years
ORR was defined as the proportion of subjects who have a complete or partial response relative to baseline .
7 secondary outcomes
AEs+SAEs
Time frame: 30 days after the last dose
PFS by investigator
Time frame: up to 2 years
Overall Survival (OS)
Time frame: up to 3 years
Pharmacokinetic characteristic
Time frame: up to 2 years
Pharmacokinetic characteristic
Time frame: up to 2 years
Pharmacokinetic characteristic
Time frame: up to 2 years
Pharmacokinetic characteristic
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Derived from this study: PubMed 37969395Hou 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.
- ClinicalTrials.gov Results Data Element Definitions for Interventional and Observational StudiesLink provided by the sponsor.
- Checklists, templates, and examples to help gather information needed to report results to ClinicalTrials.govLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib and Etoposide capsule and Apatinib in people with Ovarian Cancer, run by Jiangsu HengRui Medicine Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaoyu Zhong, M.M (+86 15045090779, zhongzhaoyu@hrglobe.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) by investigator (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04383977, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.