Ovarian CancerPhase 3NCT04000295
Apatinib and Etoposide Capsule Versus Weekly Paclitaxel in Patients With Platinum Resistant Ovarian Cancer
A Phase 3 study testing Apatinib, Etoposide and Paclitaxel in people with Ovarian Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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). 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, Etoposide and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 16 Aug 2019to Jul 2022
- Phase
- Phase 3
- 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
- 18 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University
Guangzhou, Guangdong, 510000
Xin Huang, professor
Chunyan Lan, professor
About this study
Official title: AMELIE: A Phase 3 Randomized, Open-label, Multicenter Trial of Apatinib and Etoposide Capsule Versus Weekly Paclitaxel 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) 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).
- Conditions
- Ovarian Cancer
- Being tested
- Apatinib, Etoposide, Paclitaxel
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Subjects receive Apatinib orally, Dosage form: tablet, Strength: 375 mg/d
EtoposideDrug
Subjects receive Etoposide capsule orally, d1-14, q3w, Dosage form: capsule, Strength: 50 mg/d
PaclitaxelDrug
Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, q3w, Dosage form: injectable, Strength: 80 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Apatinib; Drug: Etoposide |
| Weekly Paclitaxel | Active comparator | Weekly Paclitaxel (80 mg/m2, d1, d8, d15, q3w) until disease progression or intolerable toxicity Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to approximately 2 years
Secondary outcomes (6)
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0
Measured: up to approximately 2 years
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 approximately 2 years
Objective Response Rate (ORR)
Proportion of subjects who have a complete or partial response relative to baseline as assessed per RECIST 1.1 criteria as well as Gynecologic Cancer Intergroup (GCIG) cancer antigen (CA)-125 criteria.
Measured: up to approximately 2 years
Overall Survival (OS)
OS is the time interval from the date of randomization to death from any cause.
Measured: up to approximately 3 years
EQ-5D-5L questionnaire
EQ-5D-5L is a questionnaire that focus on issues specific to ovarian cancer.
Measured: up to approximately 2 years
FOSI-8 questionnaire
FOSI-8 is a questionnaire that focus on issues specific to ovarian cancer.
Measured: up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start16 Aug 2019
- Primary completionJan 2021 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 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
- NCT04000295
- Sponsor's protocol ID
- Ahead-OC-301
- Status last verified
- Jun 2019
- First submitted
- 24 Jun 2019
- Last updated
- 8 Oct 2019
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMELIE: A Phase 3 Randomized, Open-label, Multicenter Trial of Apatinib and Etoposide Capsule Versus Weekly Paclitaxel in Patients With Platinum Resistant or Refractory Ovarian Cancer
- ClinicalTrials.gov ID
- NCT04000295
- Acronym / sponsor ID
- Ahead-OC-301
- Conditions
- Ovarian Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2019 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 27 Jun 2019 (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) 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apatinib and Etoposide capsule | Experimental | Drug: Apatinib, Drug: EtoposideApatinib (375 mg qd, q3w) and Etoposide capsule(50 mg/d, d1-14, q3w) combination until disease progression or intolerable toxicity |
| Weekly Paclitaxel | Active comparator | Drug: PaclitaxelWeekly Paclitaxel (80 mg/m2, d1, d8, d15, 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)
- 18 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
Key exclusion criteria (4 listed)
- 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)
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 |
|---|---|---|
| ApatinibSubjects receive Apatinib orally, Dosage form: tablet, Strength: 375 mg/d | Drug | Apatinib and Etoposide capsule |
| EtoposideSubjects receive Etoposide capsule orally, d1-14, q3w, Dosage form: capsule, Strength: 50 mg/d | Drug | Apatinib and Etoposide capsule |
| PaclitaxelSubjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, q3w, Dosage form: injectable, Strength: 80 mg/m2 | Drug | Weekly Paclitaxel |
Primary outcome
Progression free survival(PFS) by independent review committee(IRC)
Time frame: up to approximately 2 years
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
6 secondary outcomes
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: up to approximately 2 years
PFS by investigator
Time frame: up to approximately 2 years
Objective Response Rate (ORR)
Time frame: up to approximately 2 years
Overall Survival (OS)
Time frame: up to approximately 3 years
EQ-5D-5L questionnaire
Time frame: up to approximately 2 years
FOSI-8 questionnaire
Time frame: up to approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apatinib, Etoposide and Paclitaxel in people with Ovarian Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
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 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Progression free survival(PFS) by independent review committee(IRC) (time frame: up to approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2019.