AzTrials
AzTrials

Ovarian CancerPhase 2NCT03901118

Chiauranib in Combination With Chemotherapy in Patients With Ovarian Cancer

A Phase 2 study testing chiauranib, etoposide and paclitaxel 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
Search all trials

Trial 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. 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, etoposide and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteChina
Study dates
1 Jul 2019to 18 Dec 2020
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

  • 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.
Show all 16Show fewer
  • 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.

Who cannot join

  • 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;
Show all 26Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
Ovarian Cancer
Being tested
chiauranib, etoposide, paclitaxel
Keywords
ovarian cancer, relapsed or refractory, chiauranib, chemotherapy
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

    in the phase of pilot trial, 25mg orally once daily; in the formal phase, 50mg orally once daily

  • etoposideDrug

    Also called Lastet

    50mg orally once daily for 21 days, 7 days off, every 28 days for a cycle, 6 cycles at most

  • paclitaxelDrug

    Also called Anzatax

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

Study groups in NCT03901118
Study groupRoleWhat they receive
chiauranib plus etoposideExperimentalPatients 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.
Receives: Drug: chiauranib; Drug: etoposide
chiauranib plus paclitaxelExperimentalPatients 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.
Receives: Drug: chiauranib; Drug: paclitaxel

What is being measured

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

  1. progression-free survival (PFS)

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

    Measured: assessed up to 1 years

Secondary outcomes (4)

  1. overall response rate (ORR)

    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

    Measured: assessed up to 2 years

  2. overall survival (OS)

    OS is defined as the length of time from treatment to death from any cause

    Measured: assessed up to 2 years

  3. time to progression(TTP)

    From date of the first dose of study drug until the date of first documented progression NOT including death

    Measured: assessed 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

Timeline

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

  1. First posted3 Apr 2019
  2. Study start1 Jul 2019
  3. Primary completion18 Dec 2020
  4. Study completion18 Dec 2020

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03901118
Sponsor's protocol ID
CAR201
Status last verified
Mar 2021
First submitted
29 Mar 2019
Last updated
19 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 2 study testing chiauranib, etoposide and paclitaxel 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 16 inclusion and 26 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 19 Mar 2021. 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 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?

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?

progression-free survival (PFS) (time frame: assessed up to 1 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 NCT03901118, 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 19 Mar 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in