Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase Ib Study of Chiauranib in Patients With Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03166891
Recruitment Status : Completed
First Posted : May 25, 2017
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Chipscreen Biosciences, Ltd.

Brief Summary:
Chiauranib may stop the growth of tumor cells by blocking Aurora kinase B(Aurora B)、VEGFR/PDGFR/c-Kit、CSF-1R targets. This clinical trial is studying the efficacy and safety of chiauranib(50mg,QD,PO) works in treating patients with relapsed or refractory ovarian cancer, in the meantime, exploring the latent biomarkers accompany with chiauranib, as well as the relevancy of which and clinical benefit.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Chiauranib Phase 1 Phase 2

Detailed Description:
The purpose of this study is to assess the efficacy and safety include adverse events, vital signs, laboratory tests ,etc., of Chiauranib in ovarian cancer patients due to the outcomes of the phase I study, and to explore the relevance between the latent biomarkers of Chiauranib and clinical benefit.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Chiauranib in Relapsed/Refractory Ovarian Cancer: a Single-arm, Open-label, Multi-site, Exploratory Study
Actual Study Start Date : December 15, 2017
Actual Primary Completion Date : March 20, 2019
Actual Study Completion Date : March 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: chiauranib
Patients take Chiauranib capsules 50mg, orally once daily, 28 days as a cycle.
Drug: Chiauranib
Take 50mg orally once daily
Other Name: CS2164




Primary Outcome Measures :
  1. Overall response rate(ORR) [ Time Frame: assessed up to 2 years ]
    ORR will be calculated from the data obtained from the end visit


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events [ Time Frame: measured through 2 years ]
    measured by adverse events (AE), serious adverse events (SAE), abnormal vital signs,electrocardiograph(ECG) and abnormal laboratory results according to CTCAE V4.03

  2. Progression-free survival (PFS) [ Time Frame: assessed up to 2 years ]
    From date of treatment until the date of first documented progression or date of death from any cause, whichever came first

  3. Time to progression(TTP) [ Time Frame: through treatment completion, up to 2 years ]
    duration from date of treatment until the date of first documented progression

  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

  5. Overall survival(OS) [ Time Frame: assessed up to 2 years ]
    Time from treatment to death from any cause

  6. 16 week-disease control rate(16W-DCR) [ Time Frame: assessed up to 2 years ]
    Rate of the patients with disease control longer than 6 weeks


Other Outcome Measures:
  1. immunohistochemical(IHC) staining results of Aurora B、CSF-1R and Myc protein [ Time Frame: assessed up to 2 years ]
    The IHC staining results were assigned a mean follows: 0, negative; 1, weak; 2, moderate; and 3, strong. The frequency of positive cells was defined as follows: 0, less than 5%; 1, 5% to 25%; 2, 26% to 50%; 3, 51% to 75%; and 4,greater than 75%.

  2. Any single mutation of oncogene and copy number variation in ctDNA(single gene analysis) [ Time Frame: assessed up to 2 years ]
  3. Mutation of polygene and copy number variation in signal pathway(multi-gene analysis) [ Time Frame: assessed up to 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 tubae, or primary peritoneal carcinoma.
  3. Patients have received platinum containing chemotherapy, a) platinum resistant disease (disease progression within 6 months of the last receipt of platinum-based chemotherapy), the disease has progressed or relapsed after at least 2 different chemotherapy regimens; b) platinum sensitive disease (disease progression after 6 months of the last receipt of platinum-based chemotherapy), the disease has progressed or relapsed at least 2 different chemotherapy regimens, or the patients refuse any chemotherapy.
  4. At least 1 lesion can be accurately measured, as defined by RECIST1.1.
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  6. Subjects received anti-cancer therapy (including chemotherapy, radiotherapy, immunotherapy and surgical therapy, et al) should beyond 4 weeks prior to study entry; Subjects received mitomycin chemotherapy should beyond 6 weeks prior to study entry.
  7. 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: total bilirubin≦1.5×ULN; alanine aminotransferase(ALT) ,aspartate aminotransferase(AST)≦1.5×ULN; (ALT,AST≦5×ULN if liver involved) ;serum creatinine(cr)≦1.5×ULN; Coagulation test: International Normalized Ratio (INR) < 1.5.

  8. Life expectancy of at least 12 weeks.
  9. Willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Patients with prior invasive malignancies with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ, unless received curative treatment and with documented evidence of no recurrence in the past five years;
  2. Clinical evidence of central nervous system involvement;
  3. 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.
  4. Have active bleeding current thrombotic disease, patients with bleeding potential ,or receiving anticoagulation therapy; within 2 months prior to screening;
  5. Proteinuria positive(≥1g/24h).
  6. History of deep vein thrombosis or pulmonary embolism;
  7. Have unsolved toxicities (> grade 1) from prior anti-cancer therapy;
  8. 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.
  9. History of organ transplantation.
  10. Major surgery within 6 weeks and minor surgery within 2 weeks prior to screening (excluding placement of vascular access or biopsy) that involved general anaesthesia or respiratory assistance.
  11. Serologically positive for HIV, hepatitis B or C, or other serious infectious diseases.
  12. History of interstitial lung disease(ILD).
  13. Previous treatment with aurora kinase inhibitors.
  14. Any mental or cognitive disorder, that would impair the ability to understand the informed consent document or the operation and compliance of study;
  15. Candidate with drug and alcohol abuse.
  16. 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).
  17. 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): NCT03166891


Locations
Layout table for location information
China, Shanghai
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Chipscreen Biosciences, Ltd.

Layout table for additonal information
Responsible Party: Chipscreen Biosciences, Ltd.
ClinicalTrials.gov Identifier: NCT03166891    
Other Study ID Numbers: CAR102
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
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