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Ovarian CancerPhase 1/2NCT03166891

Phase Ib Study of Chiauranib in Patients With Ovarian Cancer

A Phase 1/2 study testing Chiauranib in people with Ovarian Cancer, run by Chipscreen Biosciences, Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Chiauranib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
15 Dec 2017to 20 Mar 2019
Phase
Phase 1/2
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

  • Female, aged ≥ 18 yrs and ≤70 yrs;
  • Histological or cytological confirmation of epithelial ovarian cancer, carcinoma tubae, or primary peritoneal carcinoma.
  • 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.
  • At least 1 lesion can be accurately measured, as defined by RECIST1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • 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.
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  • 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.
  • Life expectancy of at least 12 weeks.
  • Willingness to sign a written informed consent document.

Who cannot join

  • 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;
  • 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
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  • 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 (excluding placement of vascular access or biopsy) that involved general anaesthesia or respiratory assistance.
  • Serologically positive for HIV, hepatitis B or C, or other serious infectious diseases.
  • History of interstitial lung disease(ILD).
  • Previous treatment with aurora kinase inhibitors.
  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: Efficacy and Safety of Chiauranib in Relapsed/Refractory Ovarian Cancer: a Single-arm, Open-label, Multi-site, Exploratory Study

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.

Read the 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.

Conditions
Ovarian Cancer
Being tested
Chiauranib
Keywords
ovarian cancer, relapsed or refractory,chiauranib
Medical subject headings
Ovarian Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChiauranibDrug

    Also called CS2164

    Take 50mg orally once daily

Study groups in NCT03166891
Study groupRoleWhat they receive
chiauranibExperimentalPatients take Chiauranib capsules 50mg, orally once daily, 28 days as a cycle.
Receives: Drug: Chiauranib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate(ORR)

    ORR will be calculated from the data obtained from the end visit

    Measured: assessed up to 2 years

Secondary outcomes (6)

  1. Number of participants with treatment-related adverse events

    measured by adverse events (AE), serious adverse events (SAE), abnormal vital signs，electrocardiograph(ECG) and abnormal laboratory results according to CTCAE V4.03

    Measured: measured through 2 years

  2. Progression-free survival (PFS)

    From date of treatment until the date of first documented progression or date of death from any cause, whichever came first

    Measured: assessed up to 2 years

  3. Time to progression(TTP)

    duration from date of treatment until the date of first documented progression

    Measured: through treatment completion, up to 2 years

  4. Duration of response (DOR)

    From the first date of response until the date of first documented progression

    Measured: assessed up to 2 years

  5. Overall survival(OS)

    Time from treatment to death from any cause

    Measured: assessed up to 2 years

  6. 16 week-disease control rate(16W-DCR)

    Rate of the patients with disease control longer than 6 weeks

    Measured: assessed up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2017
  2. Study start15 Dec 2017
  3. Primary completion20 Mar 2019
  4. Study completion20 Mar 2019

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03166891
Sponsor's protocol ID
CAR102
Status last verified
Jul 2019
First submitted
22 May 2017
Last updated
18 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Li J, Liu J, Yin R, Zou D, Zheng H, Cao J, Chen Z, Sun W, Gao Y, Zhang S, Zeng L, An R, Lu X, Ye S, Wu X. Efficacy and safety of chiauranib in a combination therapy in platinum-resistant or refractory ovarian cancer: a multicenter, open-label, phase Ib and II study. Mol Cancer. 2024 Aug 9;23(1):162. doi: 10.1186/s12943-024-02076-x.

    PubMed 39123210

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Chiauranib in people with Ovarian Cancer, run by Chipscreen Biosciences, 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 10 inclusion and 22 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: finished, as of the sponsor's last update on 18 Jan 2020. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate(ORR) (time frame: assessed up to 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 NCT03166891, 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 18 Jan 2020.

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