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Ovarian CancerPhase 3CHIPRONCT04921527

Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer

A Phase 3 study testing chiauranib and Paclitaxel in people with Ovarian Cancer and Relapsed or Refractory, run by Chipscreen Biosciences, Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This randomized, double-blind, 2-arm study will evaluate the efficacy and safety of Chiauranib plus weekly paclitaxel versus placebo plus weekly paclitaxel in patients with Platinum-refractory or Platinum-resistant Recurrent ovarian cancer. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Ovarian Cancer, Relapsed or Refractory, Chiauranib
What is being tested?
chiauranib and Paclitaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
454 participants
Where
1 siteChina
Study dates
20 Dec 2021to 31 Jul 2025
Phase
Phase 3
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

  • Willingness to sign a written informed consent document .
  • Female, age ≥18 yrs and ≤70 yrs.
  • Histological or cytological confirmation of epithelial ovarian cancer, carcinoma tube, or primary peritoneal carcinoma.
  • Patients with platinum refractory or platinum resistant ovarian cancer:
  • Platinum refractory: progression during the first platinum-based treatment or within 4 weeks after the first platinum-based primary therapy;
  • Platinum resistant: progression during the platinum-based treatment except for platinum refractory, or within 6 months after the last receipt of platinum-based treatment (patients have received platinum containing chemotherapy at least 4 weeks);
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  • Radiological progression during the last treatment administered;
  • no more than 1 prior treatment regimens for recurrent disease.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • At least 1 lesion can be accurately measured, as defined by RECIST1.1.
  • 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, activeated partial thromboplasting time (APTT) <1.5×ULN
  • Life expectancy of at least 3 months.

Who cannot join

  • 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 weekly paclitaxel therapy.
  • Has known allegies to Chiauranib, paclitaxel or any of the excipients.
  • Biological therapy, immunotherapy, hormonal therapy within 28 days prior to the first dose of study drug.
  • prior major surgery or trauma within 14 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
  • Treatment with an investigational agent/instrument within 28 days prior to first dose of study drug.
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  • Any ongoing toxicity from prior anti-cancer therapy that is >Grade 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.
  • History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis.
  • clinically significant central/peripheral nervous system disease.
  • 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
  • History of hypertension treated by≥2 agents, or the Blood pressure (Bp) ≥140/90 mmHg prior to study entry.
  • Other condition investigator considered inappropriate
  • Significant intravenous or arterial thrombosis, such as cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
  • History of active bleeding within the past 2 months, patients with bleeding potential during the screening period, or receiving anticoagulation therapy.
  • CT or MRI of the chest during the screening period shows interstitial lung disease or pulmonary fibrosis or lung inflammation that requires treatment, or within 6 months before the first dose, history of pneumonia requiring oral or intravenous steroid treatment, history of immune-associated pneumonia after treatment of PD1/PDL1 inhibitor.
  • Have clinical significant gastrointestinal abnormality that would impair the ingestion, transportation or absorption of oral agents, history of gastrointestinal perforation or abdominal fistula, peptic ulcer disease within 6 months prior to first dose of study drug or GI obstruction within the past 3 months.
  • Pleural fluid, ascites or pericardial effusion with significant symptoms or required treatment of puncture or drainage during the screening period, or history of drainage for therapy within 1 months prior to first dose of study drug.
  • Screening for HIV antibody positive.
  • Screening test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with virus replication, hepatitis C antibody (HCV-Ab) positive with virus replication.
  • Active infection requiring oral or intravenous systemic antimicrobial therapy during the screening period.
  • Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or the compliance of study.
  • History of organ transplantation or allo-HSCT.
  • Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or the compliance of study.
  • Candidates with drug and alcohol abuse.
  • Participants of reproductive potential not willing to use adequate contraceptive measures for the duration of the study.Pregnant or breastfeeding women.
  • Any other condition which is inappropriate for the study in the opinion of the investigators.

Trial locations and contacts

1 site in 1 country.

Yu Chen contact

8610-56102349

chenyu@chipscreen.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, China, 200032

    Xiaohua Wu, MD, 13601772486

    Xiaohua Wu, MD

    Recruiting

Other trials in China

About this study

Official title: A Multi-center, Double-blind, Randomized Phase III Clinical Trial of Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer

This randomized, double-blind, 2-arm study will evaluate the efficacy and safety of Chiauranib plus weekly paclitaxel versus placebo plus weekly paclitaxel in patients with Platinum-refractory or Platinum-resistant Recurrent ovarian cancer.

Read the detailed description

Chiauranib is a novel orally active multi-target inhibitor that simultaneously inhibits the angiogenesis-related kinases (VEGFR2, VEGFR1, VEGFR3, PDGFRa and c-Kit), mitosis-related kinase Aurora B and chronic inflammationrelated kinase CSF-1R in a high potency manner with the IC50 at a single-digit nanomolar range. In particular, Chiauranib showed very high selectivity in the kinase inhibition profile with little activity on off-target non-receptor kinases, proteins, GPCR and ion channels, indicative of a better drug safety profile in terms of clinical relevance.

Patients will be randomized to receive treatment with either paclitaxel + Chiauranib or paclitaxel + placebo. Paclitaxel will be repeated every 21 days for a maximum of 6 cycles. Patients with objective response/stable disease after completing 6 courses of chemotherapy will continue Chiauranib or placebo until progression.

Being tested
chiauranib, Placebo, Paclitaxel
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

    50mg orally once daily

  • PlaceboDrug

    50mg orally once daily

  • PaclitaxelDrug

    Also called Anzatax

    at the first cycle, 60mg/m2, i.v infusion on day 1, 8 and 15 ; at the begining of the second cycle, after a comprehensive assessment , investigators decide whether to increase the dosage to 80mg/m2, i.v infusion on day 1, 8 and 15 ;

Study groups in NCT04921527
Study groupRoleWhat they receive
Chiauranib plus weekly paclitaxelExperimentalPatients receive the combined treatment of chiauranib plus paclitaxel, 21 days for a cycle, 6 cycles at most,Chiauranib is given orally, 50mg once daily. Paclitaxel is given in intravenous infusion on Day 1, 8 and 15. After 6 cycles combined treatment, patients enter the single agent therapy of chiauranib.
Receives: Drug: chiauranib; Drug: Paclitaxel
placebo plus weekly paclitaxelPlacebo comparatorPatients receive the combined treatment of placebo plus paclitaxel, 21 days for a cycle, 6 cycles at most,placebo is given orally, 50mg once daily. Paclitaxel is given in intravenous infusion on Day 1, 8 and 15. After 6 cycles combined treatment, patients enter the single agent therapy of placebo.
Receives: Drug: Placebo; 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 (Assessed by IRC)

    Measured: assessed up to 1 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

Secondary outcomes (6)

  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. duration of response (DOR)

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

    Measured: assessed up to 2 years

  3. Disease control rate (DCR)

    DCR is defined as the Proportion of participants in partial, complete or stable desease according to RECIST 1.1. criteria

    Measured: assessed up to 2 years

  4. Quality of life (QoL)

    QoL assessed by EORTC QLQ-OV28

    Measured: assessed up to 2 years

  5. Toxicity according to NCI CTCAE v5.0 criteria

    tolerance of the treatment based on AE occurrence according to NCI CTCAE v5.0 criteria

    Measured: assessed up to 2 years

  6. PK parameters of paclitaxel, chiauranib and M345

    PK parameters include but not limited to AUC, Cmax, Tmax etc.

    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 posted10 Jun 2021
  2. Study start20 Dec 2021
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Jul 2025 (estimated)

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
454 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04921527
Sponsor's protocol ID
CAR301
Acronym
CHIPRO
Status last verified
Oct 2024
First submitted
3 Jun 2021
Last updated
18 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing chiauranib and Paclitaxel in people with Ovarian Cancer and Relapsed or Refractory, 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 15 inclusion and 31 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: status not confirmed, as of the sponsor's last update on 18 Oct 2024. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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

Contact Yu Chen (8610-56102349, chenyu@chipscreen.com), or a site near the patient. 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). The study lists 2 primary outcomes in all. 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 NCT04921527.

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 Oct 2024.

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