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Chidamide in Combination With Chemotherapy in Patients With Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT03901118
Recruitment Status : Not yet recruiting
First Posted : April 3, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Chipscreen Biosciences, Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: chiauranib Drug: etoposide Drug: paclitaxel Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Phase Ⅱ Clinical Trial of Chiauranib Plus Chemotherapy in Relapsed/Refractory Ovarian Cancer
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021


Arm Intervention/treatment
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.
Drug: chiauranib
in the phase of pilot trial, 25mg orally once daily; in the formal phase, 50mg orally once daily
Other Name: CS2164

Drug: etoposide
50mg orally once daily for 21 days, 7 days off, every 28 days for a cycle, 6 cycles at most
Other Name: Lastet

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.
Drug: chiauranib
in the phase of pilot trial, 25mg orally once daily; in the formal phase, 50mg orally once daily
Other Name: CS2164

Drug: paclitaxel
60mg/m2, i.v infusion on day 1, 8 and 15, every 21 days for a cycle, 6 cycles at most
Other Name: Anzatax




Primary Outcome Measures :
  1. progression-free survival (PFS) [ Time Frame: assessed up to 1 years ]
    From the first time of treatment until the date of first documented progression or date of death from any cause, whichever comes first


Secondary Outcome Measures :
  1. overall response rate (ORR) [ Time Frame: assessed up to 2 years ]
    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

  2. overall survival (OS) [ Time Frame: assessed up to 2 years ]
    OS is defined as the length of time from treatment to death from any cause

  3. time to progression(TTP) [ Time Frame: assessed up to 2 years ]
    From date of the first dose of study drug until the date of first documented progression NOT including death

  4. duration of response (DOR) [ Time Frame: assessed up to 2 years ]
    From the first date of response until the date of first documented progression



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female, aged ≥ 18 yrs and ≤70 yrs;
  2. Histological or cytological confirmation of epithelial ovarian cancer, carcinoma tube, or primary peritoneal carcinoma.
  3. Patients with platinum-resistant or platinum-refractory ovarian cancer,

    1. platinum-resistant disease (disease progression within 6 months of the last receipt of platinum-based chemotherapy);
    2. platinum-refractory disease (disease progression during the period of platinum-based chemotherapy);
    3. patients are platinum-sensitive for the first time, then disease progression within 6 months of the last receipt of platinum-based chemotherapy.
  4. 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.
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  6. At least 1 lesion can be accurately measured, as defined by RECIST1.1.
  7. 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.
  8. Laboratory criteria are as follows:

    1. Complete blood count: hemoglobin (Hb) ≥90g/L ; absolute neutrophil count (ANC) ≥1.5×109/L ; platelets ≥90×109/L;
    2. 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) ;
    3. Coagulation test: International Normalized Ratio (INR) < 1.5.
  9. Life expectancy of at least 3 months.
  10. Willingness to sign a written informed consent document.

Exclusion Criteria:

  1. 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;
  2. Patients with allergic to Chiauranib, Etoposide and Paclitaxel;
  3. Patients received vascular endothelial growth factor(VEGF)/vascular endothelial growth factor receptor(VEGFR) inhibitor, like Apatinib, Anlotinib, Fruquintinib, Bevacizumab, etc., or Aurora kinase inhibitors;
  4. Patients received Etoposide therapy;
  5. Patients received weekly Paclitaxel therapy ;
  6. Clinical evidence of central nervous system involvement;
  7. Have uncontrolled or significant cardiovascular disease, including:

    1. 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.
    2. primary cardiomyopathy(dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al)
    3. History of significant QT interval prolongation, or Corrected QT Interval (QTc) > 470 ms prior to study entry
    4. Symptomatic coronary heart disease requiring treatment with agents
    5. Uncontrolled hypertension (≥ 140/90 mmHg) by single agent.
  8. Have active bleeding current thrombotic disease, patients with bleeding potential ,or receiving anticoagulation therapy; within 2 months prior to screening;
  9. Proteinuria positive (≥1g/24h).
  10. History of deep vein thrombosis or pulmonary embolism;
  11. Have unsolved toxicities (> grade 1) from prior anti-cancer therapy;
  12. 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;
  13. History of organ transplantation;
  14. Major surgery within 6 weeks and minor surgery within 2 weeks prior to screening;
  15. 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).
  16. History of interstitial lung disease (ILD).
  17. Any mental or cognitive disorder, that would impair the ability to understand the informed consent document or the operation and compliance of study;
  18. 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).
  19. 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);
  20. 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).
  21. Any other condition which is inappropriate for the study in the opinion of the investigators.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03901118


Contacts
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Contact: Wencheng Xu 8610-57394060 xuwencheng@chipscreen.com

Locations
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China
Fudan University Shanghai Cancer Center Not yet recruiting
Shanghai, China, 200032
Contact: Shuang Ye    86-13916283126      
Sponsors and Collaborators
Chipscreen Biosciences, Ltd.
Investigators
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Principal Investigator: Xiaohua Wu Fudan University

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Responsible Party: Chipscreen Biosciences, Ltd.
ClinicalTrials.gov Identifier: NCT03901118     History of Changes
Other Study ID Numbers: CAR201
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chipscreen Biosciences, Ltd.:
ovarian cancer, relapsed or refractory
chiauranib, chemotherapy

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Paclitaxel
Etoposide
Albumin-Bound Paclitaxel
Etoposide phosphate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors