- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03901118
Chiauranib in Combination With Chemotherapy in Patients With Ovarian Cancer
March 17, 2021 updated by: Chipscreen Biosciences, Ltd.
A Multi-center, Phase Ⅱ Clinical Trial of Chiauranib Plus Chemotherapy in Relapsed/Refractory Ovarian Cancer
This clinical trial will evaluate the efficacy and safety of chiauranib added to chemotherapy in patients with relapsed or refractory ovarian cancer, in the meantime, explore the pharmacokinetics characteristic after the combined treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This clinical trial will evaluate the efficacy and safety include adverse events, vital signs, laboratory tests, etc., of chiauranib added to chemotherapy (Paclitaxel/Etoposide) in patients with relapsed or refractory epithelial ovarian, fallopian tube or primary peritoneal cancer, in the meantime, explore the pharmacokinetics characteristic after the combined treatment.
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai, China, 200032
- Fudan University Shanghai Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female, aged ≥ 18 yrs and ≤70 yrs;
- Histological or cytological confirmation of epithelial ovarian cancer, carcinoma tube, or primary peritoneal carcinoma.
Patients with platinum-resistant or platinum-refractory ovarian cancer,
- platinum-resistant disease (disease progression within 6 months of the last receipt of platinum-based chemotherapy);
- platinum-refractory disease (disease progression during the period of platinum-based chemotherapy);
- patients are platinum-sensitive for the first time, then disease progression within 6 months of the last receipt of platinum-based chemotherapy.
- Patients have received at least 1 platinum containing chemotherapy (at least 4 cycles), the disease has progressed or relapsed no more than 2 different chemotherapy regimens.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- At least 1 lesion can be accurately measured, as defined by RECIST1.1.
- The time for participants received anti-cancer therapy (including chemotherapy, radiotherapy, immunotherapy and surgical therapy, et al) should be more than 4 weeks before enrollment; The time for participants received mitomycin chemotherapy should be more than 6 weeks before enrollment.
Laboratory criteria are as follows:
- Complete blood count: hemoglobin (Hb) ≥90g/L ; absolute neutrophil count (ANC) ≥1.5×109/L ; platelets ≥90×109/L;
- Biochemistry test: serum creatinine(cr) <1.5×ULN; total bilirubin<1.5×ULN; alanine aminotransferase(ALT) ,aspartate aminotransferase(AST)≤2.5×ULN; (ALT,AST≦5×ULN if liver involved) ;
- Coagulation test: International Normalized Ratio (INR) < 1.5.
- Life expectancy of at least 3 months.
- Willingness to sign a written informed consent document.
Exclusion Criteria:
- Patients with prior invasive malignancies in the past five years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ;
- Patients with allergic to Chiauranib, Etoposide and Paclitaxel;
- Patients received vascular endothelial growth factor(VEGF)/vascular endothelial growth factor receptor(VEGFR) inhibitor, like Apatinib, Anlotinib, Fruquintinib, Bevacizumab, etc., or Aurora kinase inhibitors;
- Patients received Etoposide therapy;
- Patients received weekly Paclitaxel therapy ;
- Clinical evidence of central nervous system involvement;
Have uncontrolled or significant cardiovascular disease, including:
- Congestive heart failure, unstable angina pectoris, myocardial infarction within 6 months prior to study entry; arrhythmia, or Left Ventricular Ejection Fraction (LVEF) < 50% requiring treatment with agents during screening stage.
- primary cardiomyopathy(dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al)
- History of significant QT interval prolongation, or Corrected QT Interval (QTc) > 470 ms prior to study entry
- Symptomatic coronary heart disease requiring treatment with agents
- Uncontrolled hypertension (≥ 140/90 mmHg) by single agent.
- Have active bleeding current thrombotic disease, patients with bleeding potential ,or receiving anticoagulation therapy; within 2 months prior to screening;
- Proteinuria positive (≥1g/24h).
- History of deep vein thrombosis or pulmonary embolism;
- Have unsolved toxicities (> grade 1) from prior anti-cancer therapy;
- Have clinical significant gastrointestinal abnormality, e.g., unable to swallow, chronic diarrhea, ileus, that would impair the ingestion, transportation or absorption of oral agents, or patients undergone gastrectomy;
- History of organ transplantation;
- Major surgery within 6 weeks and minor surgery within 2 weeks prior to screening;
- Serologically positive for HIV, hepatitis B or C, or other serious infectious diseases (positive infectious diseases refer to that needed systemic therapy; HIV, hepatitis B or C: qualitative detection priority, quantitative detection if needed).
- History of interstitial lung disease (ILD).
- Any mental or cognitive disorder, that would impair the ability to understand the informed consent document or the operation and compliance of study;
- Candidate with drug and alcohol abuse (alcohol abuse: alcohol consumption is no more than 5040ml beer or 2100ml wine or 630ml strong wine with alcohol content tops out at 40 percent each week).
- Patients participated in other clinical trials in 4 weeks before enrollment, or washout period less than 5 half-life after received other clinical trial drugs (whichever is the longest);
- Participants of reproductive potential not willing to use adequate contraceptive measures for the duration of the study (both male and female participants).Pregnant or breastfeeding women. Female participants must have a negative urinary or serum pregnancy test when done or have evidence of post-menopausal status (Defined as absence of menstruation for greater than 12 months, bilateral oophorectomy or hysterectomy).
- Any other condition which is inappropriate for the study in the opinion of the investigators.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: chiauranib plus etoposide
Patients receive the combined treatment of chiauranib plus etoposide, 28 days for a cycle, 6 cycles at most.
In the pilot trial, Chiauranib is given orally, 25mg once daily.
After patients finish the blood collection for pharmacokinetics(PK), and if the efficacy and safety are acceptable, Chiauranib is given orally, 50mg once daily.
Etoposide is given orally, 50mg once daily for 21 days, 7 days off, in the pilot and formal study.
After 6 cycles combined treatment, patients enter the single agent therapy of chiauranib.
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in the phase of pilot trial, 25mg orally once daily; in the formal phase, 50mg orally once daily
Other Names:
50mg orally once daily for 21 days, 7 days off, every 28 days for a cycle, 6 cycles at most
Other Names:
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Experimental: chiauranib plus paclitaxel
Patients receive the combined treatment of chiauranib plus paclitaxel, 21 days for a cycle, 6 cycles at most.
In the pilot trial, Chiauranib is given orally, 25mg once daily.
After patients finish the blood collection for pharmacokinetics(PK), and if the efficacy and safety are acceptable, Chiauranib is given orally, 50mg once daily.
Paclitaxel is given in intravenous infusion on Day 1, 8 and 15, in the pilot and formal study.
After 6 cycles combined treatment, patients enter the single agent therapy of chiauranib.
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in the phase of pilot trial, 25mg orally once daily; in the formal phase, 50mg orally once daily
Other Names:
60mg/m2, i.v infusion on day 1, 8 and 15, every 21 days for a cycle, 6 cycles at most
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression-free survival (PFS)
Time Frame: assessed up to 1 years
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From the first time of treatment until the date of first documented progression or date of death from any cause, whichever comes first
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assessed up to 1 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival (OS)
Time Frame: assessed up to 2 years
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OS is defined as the length of time from treatment to death from any cause
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assessed up to 2 years
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overall response rate (ORR)
Time Frame: assessed up to 2 years
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ORR is defined as the proportion of participants who have a partial response (PR) or complete response (CR) to therapy according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
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assessed up to 2 years
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duration of response (DOR)
Time Frame: assessed up to 2 years
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From the first date of response until the date of first documented progression
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assessed up to 2 years
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time to progression(TTP)
Time Frame: assessed up to 2 years
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From date of the first dose of study drug until the date of first documented progression NOT including death
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assessed up to 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2019
Primary Completion (Actual)
December 18, 2020
Study Completion (Actual)
December 18, 2020
Study Registration Dates
First Submitted
March 29, 2019
First Submitted That Met QC Criteria
April 1, 2019
First Posted (Actual)
April 3, 2019
Study Record Updates
Last Update Posted (Actual)
March 19, 2021
Last Update Submitted That Met QC Criteria
March 17, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Protein Kinase Inhibitors
- Etoposide
- Paclitaxel
- Chiauranib
Other Study ID Numbers
- CAR201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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