Angiogenesis Inhibitors，Ovarian NeoplasmsPhase 2NCT03262545
Efficacy and Safety of Apatinib As Third Line Therapy in Patients With Advanced Ovarian Cancer
A Phase 2 study testing apatinib in people with Angiogenesis Inhibitors，Ovarian Neoplasms, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial summary
The study is to investigate the efficacy and safety of apatinib in patients with advanced ovarian cancer,who has received second-line chemotherapy and failed. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Angiogenesis Inhibitors，Ovarian Neoplasms
- What is being tested?
- apatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2017to Feb 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years to 70 years;
- Had a histologically or cytologically confirmed diagnosis of epithelial ovarian cancer；
- unfit for radical surgery and had received second-line chemotherapy，the disease still progressed or can not tolerate the chemotherapy;
- Had a disease status that was measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version1.1);
- Had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2;
- Had a life expectancy of at least 12 weeks;
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- Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥90g/L, platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, total bilirubin within 1.5×the upper limit of normal (ULN), and b) ALT and AST≤2.5×the ULN (If liver metastases, serum creatine ≤ 1.5 x ULN);
- Had not gastrointestinal diseases that lead to malabsorption or impact Drug absorption;
- had good compliance;
- Signed and dated informed consent.
Who cannot join
- patients who had received anti-vascular therapy;
- Allergic to any ingredients of Apatinib;
- Participated in other drug clinical researchers within four weeks;
- Have a variety of factors that affect oral medication (such as can not swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.)
- Severe infection;
- Patients with serious cardiovascular diseases,such as unstable angina, grade 3-4 heart dysfunction (NYHA Standard), congestive heart failure, poor-controlled arterial hypertension despite standard medical management;
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- Patients who received major surgical operations within 4 weeks before screening;
- Patients who manifested arterial/venous thrombus events, e.g.cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening;
- Past or concurrent with other malignancies, except for cured skin basal cell carcinoma and cervical in situ cancer;
- Have a history of psychiatric abuse and can not quit or have mental disorders.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 600000
Kai Mei, Phd, 13011827280, 250450418@qq.com
About this study
The study is to investigate the efficacy and safety of apatinib in patients with advanced ovarian cancer,who has received second-line chemotherapy and failed.
Read the detailed description
Ovarian cancer is the third most common gynecological malignancy，just less than endometrial cancer and cervical cancer. Because most patients with advanced ovarian cancer can not get the ideal tumor cell reduction surgery, and multi-drug resistance often emerges after repeated chemotherapy，recurrent and metastatic ovarian cancer has become one of the major diseases that threaten women's health. There is strongly necessary to explore effective therapeutic drugs and means to improve prognosis of these patients and improve the quality of life. The study，as a double blind clinical trial ,is to investigate the efficacy and safety of apatinib in patients with advanced ovarian cancer,who has received second-line chemotherapy regimens and failed. A total of 60 patients with performance status 0-2 were enrolled in this study, and were randomly divided into two groups--one group of 40 patients receiving apatinib，and another of 20 patients receiving placebo.
- Being tested
- apatinib, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apatinibDrug
Patients in experimental group will take 500mg apatinib daily orally，and patients in control group will take placebo
PlacebosDrug
Physical properties of placebos are consistent with apatinib
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | apatinib 500 mg p.o. once daily Receives: Drug: apatinib |
| control group | Placebo comparator | placebo p.o. once daily Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Time from randomization until disease progression or death
Measured: approximately 2 years
Secondary outcomes (4)
Overall survival (OS)
Time from randomization until death from any cause of death
Measured: approximately 2 years
Objective response rate (ORR)
Proportion of patients with reduction in tumor burden of a predefined amount
Measured: approximately 2 years
disease control rate (DCR)
the total proportion of patients who demonstrate a response to treatment
Measured: approximately 2 years
Quality of life (QoL)
As measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)
Measured: 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 posted25 Aug 2017
- Study start27 Aug 2017 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionFeb 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 Angiogenesis Inhibitors，Ovarian NeoplasmsStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei Kai, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262545
- Sponsor's protocol ID
- Ahead-OV-201704
- Status last verified
- Aug 2017
- First submitted
- 22 Aug 2017
- Last updated
- 28 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PubMed 37185961
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Apatinib As Third Line Therapy in Patients With Advanced Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03262545
- Acronym / sponsor ID
- Ahead-OV-201704
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 27 Aug 2017 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 25 Aug 2017 (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 to investigate the efficacy and safety of apatinib in patients with advanced ovarian cancer,who has received second-line chemotherapy and failed.
Detailed description
Ovarian cancer is the third most common gynecological malignancy，just less than endometrial cancer and cervical cancer. Because most patients with advanced ovarian cancer can not get the ideal tumor cell reduction surgery, and multi-drug resistance often emerges after repeated chemotherapy，recurrent and metastatic ovarian cancer has become one of the major diseases that threaten women's health. There is strongly necessary to explore effective therapeutic drugs and means to improve prognosis of these patients and improve the quality of life. The study，as a double blind clinical trial ,is to investigate the efficacy and safety of apatinib in patients with advanced ovarian cancer,who has received second-line chemotherapy regimens and failed. A total of 60 patients with performance status 0-2 were enrolled in this study, and were randomly divided into two groups--one group of 40 patients receiving apatinib，and another of 20 patients receiving placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: apatinibapatinib 500 mg p.o. once daily |
| control group | Placebo comparator | Drug: Placebosplacebo p.o. once daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years to 70 years;
- Had a histologically or cytologically confirmed diagnosis of epithelial ovarian cancer；
- unfit for radical surgery and had received second-line chemotherapy，the disease still progressed or can not tolerate the chemotherapy;
- Had a disease status that was measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version1.1);
- Had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2;
Key exclusion criteria (10 listed)
- patients who had received anti-vascular therapy;
- Allergic to any ingredients of Apatinib;
- Participated in other drug clinical researchers within four weeks;
- Have a variety of factors that affect oral medication (such as can not swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.)
- Severe infection;
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 |
|---|---|---|
| apatinibPatients in experimental group will take 500mg apatinib daily orally，and patients in control group will take placebo | Drug | experimental group |
| PlacebosPhysical properties of placebos are consistent with apatinib | Drug | control group |
Primary outcome
Progression-free survival (PFS)
Time frame: approximately 2 years
Time from randomization until disease progression or death
4 secondary outcomes
Overall survival (OS)
Time frame: approximately 2 years
Objective response rate (ORR)
Time frame: approximately 2 years
disease control rate (DCR)
Time frame: approximately 2 years
Quality of life (QoL)
Time frame: 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 28 Aug 2017.
- Derived from this study: PubMed 37185961Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
- Individual participant dataSharing planned: Undecided
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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 2 study testing apatinib in people with Angiogenesis Inhibitors，Ovarian Neoplasms, run by Sichuan Cancer Hospital and Research Institute 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 10 inclusion and 10 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 28 Aug 2017. 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. Some participants in this study may receive a placebo. 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 Mei Kai, Ph.D (18111277629, 250450418@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: approximately 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 NCT03262545, 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 28 Aug 2017.