AzTrials
AzTrials

Small Cell Lung CancerPhase 1/2SCLCNCT05271292

Chiauranib for Advanced Solid Malignant Tumors and Relapsed/Refractory SCLC.

A Phase 1/2 study testing Chiauranib in people with Small Cell Lung Cancer and Advanced Solid Malignant Tumor, run by Chipscreen Biosciences, Ltd. at 11 sites in United States.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

This is a Phase 1b/2, single-arm, open-label, dose-escalation study including 2 stages: Phase 1b: Dose-Escalation Stage (Single-Dose and Consecutive-Dose Periods) Phase 2: recommended Phase 2 dose (RP2D) of chiauranib will be given to all patients enrolled in this phase once daily for 28-day cycles continuously with… Read more about this study

Who is it for?
Ages 18 years and older
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
36 participants
Where
11 sitesUnited States
Study dates
26 Aug 2022to May 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is at least 18 years of age, regardless of gender. Patient has a diagnosis of histologically or cytologically confirmed advanced solid malignant tumor (including SCLC, NSCLC, colorectal carcinoma, pancreatic carcinoma, hepatocellular carcinoma, ovarian cancer, neuroendocrine tumors, non-Hodgkin's lymphoma, and others) that has relapsed from or is refractory to standard therapy or for which no standard therapy exists.
  • Patient has at least one measurable target lesion as defined by RECIST1.1, i.e., a lesion that has radiologic evidence of disease progression, after treatment with radiotherapy or local-regional therapy.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at enrollment.
  • Major organ functions meet the following criteria (no corrective treatment, such as G CSF, erythropoietin, and blood transfusion, within 2 weeks before enrollment):
  • Hematology: absolute neutrophil count (ANC) ≥1.5×109/L, platelet ≥100×109/L, hemoglobin ≥100 g/L.
  • Biochemistry: total bilirubin ≤1.25×upper limit of normal (ULN), both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×ULN (≤5×ULN for patients with hepatic metastasis), creatinine clearance >60 mL/min (according to Cockcroft-Gault equation), fasting triglyceride ≤3.0 mmol/L, fasting total cholesterol ≤7.75 mmol/L.
Show all 11Show fewer
  • Coagulation panel: international normalized ratio (INR) <1.5.
  • Patient has a life expectancy ≥3 months.
  • Patient is able to provide voluntary informed consent.
  • Women of childbearing potential (WOCBP) must be willing and able to take highly effective contraceptive measures during the entire study treatment period and for 12 weeks after the last dose of study drug (see Appendix 11.7). Women of childbearing potential include premenopausal and not sterilized (by hysterectomy, bilateral ligation of fallopian tubes, or bilateral oophorectomy) females who have passed menarche.
  • Male patients must be willing and able to use male condoms and their female partners who are WOCBP during the entire study treatment and for the 12 weeks after the last dose of the study drug.

Who cannot join

  • Patient has received any systemic anticancer therapy (including chemotherapy, targeted therapy, biological immunotherapy, any investigational drug, or anti-cancer herbal medicine) within 21 days before enrollment, or any blood support therapy (including blood transfusion, blood products, or hematopoiesis stimulating agents such as granulocyte-colony stimulating factor [G-CSF]) within 2 weeks before enrollment.
  • Patients who are receiving corticosteroids at a dose of > 10 mg prednisone or equivalent of other systemic steroids will be excluded.
  • Patient with prior or concurrent malignancy whose natural history or treatment has the potential to interfere with safety or efficacy assessment of investigational regimen.
  • Patient has uncontrolled or significant cardiovascular diseases, including:
  • New York Heart Association (NYHA) grade II or higher congestive cardiac failure, unstable angina pectoris, and/or myocardial infarction within the 6 months prior to the first dose of the investigational drug, clinically significant arrhythmia unable to be controlled with medical treatment or left ventricular ejection fraction (LVEF) < 50% at screening.
  • Primary cardiomyopathies (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy).
Show all 25Show fewer
  • Clinically significant history of prolonged QTc interval, or QTcF interval >470ms for females or >450 ms for males during screening.
  • Coronary heart disease with symptoms requiring medication.
  • Patient has hypertension at screening (defined as systolic blood pressure [SBP] ≥140 mmHg, diastolic blood pressure [DBP] ≥90 mmHg). (Patients with a known history of hypertension if blood pressure is considered well controlled on a single anti-hypertensive medication (systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg at screening) and in whom there has been no change in blood pressure medication for 3 months prior to screening due to poor control.)
  • Patient has active hemoptysis, has had active bleeding within 6 months prior to enrollment, or has definite predisposition to gastrointestinal bleeding as determined by the investigator (e.g., esophageal varix associated with bleeding risk, local active ulcer lesions).
  • Patient has uncontrolled pleural effusion, hydropericardium, or ascites.
  • Patient has active or symptomatic central nervous system (CNS) metastases that require treatment.
  • Patient has a history of deep vein thrombosis, pulmonary embolism, or other serious thrombotic event within 6 months prior to enrollment.
  • Patient has an interstitial lung disease (ILD) that requires treatment, such as idiopathic interstitial pneumonia, pulmonary fibrosis, or evidence of ILD in baseline chest computed tomography (CT) or magnetic resonance imaging (MRI).
  • Patient has any current toxicity (except alopecia) of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, Grade 2 or higher caused by previous therapy.
  • Patient has clinically significant gastrointestinal abnormalities that may affect the intake, transport, or absorption of the study drug (e.g., inability to swallow, chronic diarrhea, intestinal obstruction), or has had total gastrectomy, according to the investigator's judgment.
  • Patients has undergone a major surgical operation within 6 weeks prior to screening or a minor surgical operation within 2 weeks prior to screening. A major surgical operation refers to an operation involving general anesthesia but excludes procedures such as endoscopies for diagnostic purpose or an implantation of vascular access devices.
  • Patient has urine protein ≥2+ by urine routine examination and urine protein ≥1 g/24 h by 24-hour urine protein quantification.
  • Patient has serious active infection or known infectious disease including hepatitis B, hepatitis C infection in active stage, or HIV/AIDS.
  • Patient has any mental or cognitive impairment that may limit their understanding and implementation of written informed consent and compliance in this study.
  • Patient has previously experienced toxicity leading to discontinuation of treatment with Aurora kinase inhibitors or VEGF/VEGFR inhibitors, such as sorafenib, sunitinib, pazopanib, bevacizumab, regorafenib, axitinib, vandetanib, or dasatinib.
  • Patient has current drug or alcohol abuse disorders that may affect study participation, according to the investigator's judgment.
  • Women who are pregnant, planning to become pregnant, lactating, or who have positive pregnancy test results at screening or before the first dose.
  • Patients who are currently taking and have to continue taking strong CYP3A4 inhibitor drugs, such as ketoconazole, itraconazole, clarithromycin, telithromycin, nefazodone, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, or tipranavir, as well as strong CYP3A4 inducers, such as rifampin, dexamethasone, carbamazepine, during Phase 1b (dose escalation stage) of the study.
  • Any other conditions that make the patient inappropriate for participation in this study, at the investigator's discretion.

Trial locations and contacts

11 sites in 1 country.

Zhijian Li, MD contact

732-584-6269

zhijian_li@chipscreen.com

Liz Wieland contact

Elizabeth_Wieland@chipscreen.com

11 sites in 1 country

United States11 sites, 11 recruiting

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

    Mashunte Holmes, mashunte.holmes@emory.edu

    Jennifer Carlisle

    Recruiting

  • Dana Farber Cancer Institue

    Boston, Massachusetts, 02215

    Diandra Ocot, Diandra_ocot@dfci.harvard.edu

    Jacob Sands, MD

    Recruiting

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

    Nashat Gabrail, MD, 330-492-3345, research@gabrailcancercenter.com

    Nashat Gabrail, MD

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Hirva Mamdani, MD, 313-576-8711, mamdanih@karmanos.org

    Hirva Mamdani, MD

    Recruiting

  • California Cancer Associates-Encintas

    Encinitas, California, 92024

    Christina Spencer, 760-452-3909, CSpencer@ccare.com

    Alberto Besseduo, MD

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Carrie Friedman, Carrie.Friedman@usoncology.com

    Alexander Spira, MD

    Recruiting

  • Providence/St. Joe Cancer Institute/Crosson Cancer Institute

    Fullerton, California, 92835

    Mirza "Hadi" Al Baig, mirza.baig@providence.org

    Yung Lyou, MD

    Recruiting

  • North Houston Cancer Clinics

    Huntsville, Texas, 77340

    Elham Abbasi, MD, 936-439-5213, eli@nhcancerclinics.com

    Roham Garvashi, MD, (936)439-5213, rdarvishi@nhcancerclinics.com

    Recruiting

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89119

    Ann Lovelace, 702-952-3449, Ann.Lovelace@usoncology.com

    Liawaty Ho

    Recruiting

  • Sarah Cannon Research Center

    Nashville, Tennessee, 37203

    David R Spigel, MD, 615-329-7294, david.spigel@sarahcannon.com

    Recruiting

  • OU Health

    Oklahoma City, Oklahoma, 73104

    Christina Caldwell, 405-271-8001 ext. 48171, Christina-Caldwell@ouhsc.edu

    Abdul Rafeh Naqash

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1b/2, Single-Arm, Open-Label, Dose-Escalation, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Chiauranib for the Treatment of Advanced Solid Tumors and Relapsed/Refractory SCLC

This is a Phase 1b/2, single-arm, open-label, dose-escalation study including 2 stages:

Phase 1b: Dose-Escalation Stage (Single-Dose and Consecutive-Dose Periods)

Phase 2: recommended Phase 2 dose (RP2D) of chiauranib will be given to all patients enrolled in this phase once daily for 28-day cycles continuously with no interruption between cycles.

Read the detailed description

Phase 1b:

Patients with advanced solid malignant tumor (including SCLC, NSCLC, colorectal carcinoma, pancreatic carcinoma, hepatocellular carcinoma, ovarian cancer, neuroendocrine tumors, non-Hodgkin's lymphoma and others) that has relapsed from or is refractory to standard therapy or for which no standard therapy exists will be enrolled to the 35 mg, 50 mg and 65 mg dose cohorts in this stage. The starting dose is 35 mg, and each higher dose cohort will not enroll until the lower dose is deemed safe.

After screening, eligible patients will be enrolled sequentially in 3 dose-escalating cohorts. Based on an estimated average body weight of 60 kg, the initial dose of chiauranib will be 35 mg once daily, and the dose will be escalated to 50 mg and 65 mg once daily, depending on the occurrence and frequency of DLTs. The 3+3 design will be employed in dose escalation decisions.

Each dose cohort will enroll at least 3 patients. Overenrolling dosing cohorts is allowed to allow for potential screen failures and/or subjects who end up being not evaluable by not completing the DLT evaluation period. Each subject will undergo both a single-dose period (6 days) and a consecutive-dose (1 cycle of 28 days) period, as described below. DLTs will be evaluated during this period (a total of 34 days).

Phase 2:

SCLC patients with progressive disease or recurrence after at least 2 previous regimens, including one platinum-based chemotherapy, will be enrolled in this stage. The RP2D will be given to all subjects enrolled in this stage. Subjects will take the RP2D chiauranib once daily for 28-day cycles continuously with no interruption between cycles.

Being tested
Chiauranib
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • ChiauranibDrug

    Also called CS2164

    Phase 1b: Each patient will undergo both a single-dose period (6 days) and a consecutive-dose (1 cycle of 28 days) period

    Phase 2: Patients will take the RP2D once daily for 28-day cycles continuously with no interruption between cycles

Study groups in NCT05271292
Study groupRoleWhat they receive
Study arm (35 mg)ExperimentalPhase 1b: Patients will be enrolled sequentially in 3 dose-escalating cohorts (Chiauranib capsules 35, 50, and 65 mg, orally)
Receives: Drug: Chiauranib
Study arm (50 mg)ExperimentalPhase 1b: Patients will be enrolled sequentially in 3 dose-escalating cohorts (Chiauranib capsules 35, 50, and 65 mg, orally)
Receives: Drug: Chiauranib
Study arm (65 mg)ExperimentalPhase 1b: Patients will be enrolled sequentially in 3 dose-escalating cohorts (Chiauranib capsules 35, 50, and 65 mg, orally)
Receives: Drug: Chiauranib

What is being measured

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

  1. Incidence of adverse events (AEs) and other safety parameters

    Number of patients experienced AEs

    Measured: Until 30 days after a patient takes the last dose of the study drug

  2. Incidence and characteristics of DLTs

    Number of patients experienced any dose limited toxicity

    Measured: 34 days

  3. MTD and recommended Phase 2 dose (RP2D)

    Determination of recommended phase II dose

    Measured: 34 days

Secondary outcomes (15)

  1. Time to maximum concentration (Tmax)

    PK Profile

    Measured: Phase 1b: days 1, 2, 3, 4, 5, 6, 7, 14, 21, 28 during Cycle 1; and day 28 in Cycle 2 and all subsequent cycles. Phase 2: days 1, 14, 28 during Cycle 1; and day 28 in Cycle 2 and all subsequent cycles (all cycles in phase 1b and 2 are 28 days each)

  2. Maximum plasma concentration (Cmax)

    PK Profile

    Measured: Phase 1b: days 1, 2, 3, 4, 5, 6, 7, 14, 21, 28 during Cycle 1; and day 28 in Cycle 2 and all subsequent cycles. Phase 2: days 1, 14, 28 during Cycle 1; and day 28 in Cycle 2 and all subsequent cycles (all cycles in phase 1b and 2 are 28 days each)

  3. Area under the plasma concentration-time curve from 0 to infinity (AUC 0-inf)

    PK Profile

    Measured: Phase 1b: days 1, 2, 3, 4, 5, 6, 7, 14, 21, 28 during Cycle 1; and day 28 in Cycle 2 and all subsequent cycles. Phase 2: days 1, 14, 28 during Cycle 1; and day 28 in Cycle 2 and all subsequent cycles (all cycles in phase 1b and 2 are 28 days each)

  4. Half-life (t½)

    PK Profile

    Measured: Phase 1b: days 1, 2, 3, 4, 5, 6, 7, 14, 21, 28 during Cycle 1; and day 28 in Cycle 2 and all subsequent cycles. Phase 2: days 1, 14, 28 during Cycle 1; and day 28 in Cycle 2 and all subsequent cycles (all cycles in phase 1b and 2 are 28 days each)

  5. Trough plasma concentration (Cmin)

    PK Profile

    Measured: Phase 1b: days 1, 2, 3, 4, 5, 6, 7, 14, 21, 28 during Cycle 1; and day 28 in Cycle 2 and all subsequent cycles. Phase 2: days 1, 14, 28 during Cycle 1; and day 28 in Cycle 2 and all subsequent cycles (all cycles in phase 1b and 2 are 28 days each)

  6. Area under the plasma concentration-time curve (AUC0-t)

    PK Profile

    Measured: Phase 1b: days 1, 2, 3, 4, 5, 6, 7, 14, 21, 28 during Cycle 1; and day 28 in Cycle 2 and all subsequent cycles. Phase 2: days 1, 14, 28 during Cycle 1; and day 28 in Cycle 2 and all subsequent cycles (all cycles in phase 1b and 2 are 28 days each)

  7. Oral clearance (CL/F)

    PK Profile

    Measured: Phase 1b: days 1, 2, 3, 4, 5, 6, 7, 14, 21, 28 during Cycle 1; and day 28 in Cycle 2 and all subsequent cycles. Phase 2: days 1, 14, 28 during Cycle 1; and day 28 in Cycle 2 and all subsequent cycles (all cycles in phase 1b and 2 are 28 days each)

  8. accumulation ratio

    PK Profile

    Measured: Phase 1b: days 1, 2, 3, 4, 5, 6, 7, 14, 21, 28 during Cycle 1; and day 28 in Cycle 2 and all subsequent cycles. Phase 2: days 1, 14, 28 during Cycle 1; and day 28 in Cycle 2 and all subsequent cycles (all cycles in phase 1b and 2 are 28 days each)

  9. Steady state plasma concentration (Css)

    PK Profile

    Measured: Phase 1b: days 1, 2, 3, 4, 5, 6, 7, 14, 21, 28 during Cycle 1; and day 28 in Cycle 2 and all subsequent cycles. Phase 2: days 1, 14, 28 during Cycle 1; and day 28 in Cycle 2 and all subsequent cycles (all cycles in phase 1b and 2 are 28 days each)

  10. Objective response rate (ORR)

    preliminary efficacy of chiauranib

    Measured: 6 months

  11. disease control rate (DCR)

    preliminary efficacy of chiauranib

    Measured: 6 months

  12. duration of response (DoR)

    preliminary efficacy of chiauranib

    Measured: 6 months

  13. progression-free survival (PFS)

    preliminary efficacy of chiauranib

    Measured: 6 months

  14. overall survival (OS)

    preliminary efficacy of chiauranib

    Measured: 6 months

  15. Correlation between ATRX gene mutation and efficacy

    Efficacy outcomes in patients with ATRX gene mutation and wild-type respectively.

    Measured: 6 months

Timeline

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

  1. First posted9 Mar 2022
  2. Study start26 Aug 2022
  3. Primary completionMar 2025 (estimated)
  4. Study completionMay 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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Patients will be enrolled sequentially in 3 dose-escalating cohorts (Chiauranib capsules 35mg, 50 mg and 65 mg once daily)
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05271292
Sponsor's protocol ID
CAR107
Acronym
SCLC
Status last verified
Jul 2024
First submitted
26 Jan 2022
Last updated
16 Jul 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • van Meerbeeck JP, Fennell DA, De Ruysscher DK. Small-cell lung cancer. Lancet. 2011 Nov 12;378(9804):1741-55. doi: 10.1016/S0140-6736(11)60165-7. Epub 2011 May 10.

    PubMed 21565397

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Chiauranib in people with Small Cell Lung Cancer and Advanced Solid Malignant Tumor, run by Chipscreen Biosciences, Ltd. at 11 sites in United States.

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 11 inclusion and 25 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 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. 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?

Results are not available in the source record.

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

Contact Zhijian Li, MD (732-584-6269, zhijian_li@chipscreen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) and other safety parameters (time frame: Until 30 days after a patient takes the last dose of the study drug). The study lists 3 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 NCT05271292, 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 16 Jul 2024.

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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in