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Tyrosine Kinase Inhibitor

Chiauranib for Advanced Cancers (SCLC Trial)

Phase 1 & 2
Recruiting
Led By Nashat Gabrail, MD
Research Sponsored by Chipscreen Biosciences, Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

SCLC Trial Summary

This trial is testing a new cancer drug. In the first part of the trial, the dose of the drug is gradually increased to find out what the best dose is. In the second part of the trial, all patients receive the best dose of the drug to see how well it works.

Who is the study for?
This trial is for adults with advanced solid tumors or relapsed/refractory Small Cell Lung Cancer (SCLC) who have measurable disease progression. Participants must be in good physical condition (ECOG 0-1), have proper organ function, and a life expectancy that allows participation. Women of childbearing age and men must agree to use effective contraception during the study and for some time after.Check my eligibility
What is being tested?
The trial is testing Chiauranib, an investigational drug, in two stages: Phase 1b determines the safe dosage through dose escalation, while Phase 2 administers this determined dose daily over continuous 28-day cycles without breaks to evaluate its effectiveness against cancer.See study design
What are the potential side effects?
While specific side effects of Chiauranib are not listed here, common side effects from similar cancer treatments may include fatigue, nausea, diarrhea, blood count changes increasing infection risk, liver function alterations, and potential bleeding issues.

SCLC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a tumor that can be measured and has grown after treatment.
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I can and will use effective birth control during and for 12 weeks after the study.
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My cancer has returned or hasn't responded to standard treatments.
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My blood tests, liver and kidney function, and clotting ability are within normal ranges.
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I agree to use condoms during the study and for 12 weeks after.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.

SCLC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and characteristics of DLTs
Incidence of adverse events (AEs) and other safety parameters
MTD and recommended Phase 2 dose (RP2D)
Secondary outcome measures
Area under the plasma concentration-time curve (AUC0-t)
Area under the plasma concentration-time curve from 0 to infinity (AUC 0-inf)
Correlation between ATRX gene mutation and efficacy
+12 more

SCLC Trial Design

3Treatment groups
Experimental Treatment
Group I: Study arm (65 mg)Experimental Treatment1 Intervention
Phase 1b: Patients will be enrolled sequentially in 3 dose-escalating cohorts (Chiauranib capsules 35, 50, and 65 mg, orally)
Group II: Study arm (50 mg)Experimental Treatment1 Intervention
Phase 1b: Patients will be enrolled sequentially in 3 dose-escalating cohorts (Chiauranib capsules 35, 50, and 65 mg, orally)
Group III: Study arm (35 mg)Experimental Treatment1 Intervention
Phase 1b: Patients will be enrolled sequentially in 3 dose-escalating cohorts (Chiauranib capsules 35, 50, and 65 mg, orally)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chiauranib
2017
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

Chipscreen Biosciences, Ltd.Lead Sponsor
36 Previous Clinical Trials
4,740 Total Patients Enrolled
Cabilia Pichardo, MDStudy DirectorExecutive Director of Clinical Development
Nashat Gabrail, MDPrincipal InvestigatorGabrail Cancer Center Research
3 Previous Clinical Trials
305 Total Patients Enrolled

Media Library

Chiauranib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05271292 — Phase 1 & 2
Small Cell Lung Cancer Research Study Groups: Study arm (35 mg), Study arm (50 mg), Study arm (65 mg)
Small Cell Lung Cancer Clinical Trial 2023: Chiauranib Highlights & Side Effects. Trial Name: NCT05271292 — Phase 1 & 2
Chiauranib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05271292 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test subjects are participating in this experiment?

"Ultimately, 36 people that fit the clinical study's inclusion criteria are required in order for it to proceed. The sponsor, Chipscreen Biosciences, Ltd., will be managing patient recruitment from different locations; these include Sarah Cannon Research Center in Nashville and Gabrail Cancer Center Research in Canton, Ohio."

Answered by AI

Are researchers only testing this on adults, or are minors included in the study as well?

"According to the age parameters set out in this clinical trial, any person aged 18 or older but no more than 75 years old may participate."

Answered by AI

Are we still able to enroll new patients in this research project?

"The listed clinical trial on clinicaltrials.gov is currently seeking patients. This study was first made public on 8/26/2022 and the information was last updated on 10/25/2022."

Answered by AI

What are the goals that this clinical trial is looking to achieve?

"According to the sponsor of this clinical trial, Chipscreen Biosciences, Ltd., the primary outcome being measured is incidence and characteristics of DLTs over a 34 day period. Additionally, this study will be evaluating secondary outcomes like accumulation ratio (PK Profile), Area under the plasma concentration-time curve (AUC0-t) (PK Profile), and Maximum plasma concentration (Cmax) (PK Profile)."

Answered by AI
~14 spots leftby Mar 2025