What side effects are associated with this type of intervention?

Common treatments for Small Cell Lung Cancer (SCLC) include multi-targeted kinase inhibitors like Chiauranib, as well as chemotherapy regimens such as etoposide with cisplatin and topotecan. The known side effects of these treatments can include gastrointestinal issues like diarrhea and nausea, hematologic toxicities such as neutropenia, anemia, and thrombocytopenia, as well as fatigue and decreased appetite. Specific to kinase inhibitors, additional side effects may include rash and paronychial inflammation. These side effects are generally manageable but can vary in severity among patients.

What prior FDA approvals exist?

FDA-approved treatments for Small Cell Lung Cancer (SCLC) include a variety of chemotherapy and immunotherapy agents. Among multi-targeted kinase inhibitors, Lenvatinib and Sunitinib are notable, although they are primarily approved for other cancers like renal cell carcinoma and thyroid cancer. These drugs target multiple pathways, including VEGFR and RET, similar to the approach of Chiauranib. Additionally, immune checkpoint inhibitors such as Atezolizumab and Durvalumab have been approved for SCLC, often in combination with chemotherapy.

What other types of research exist?

Promising novel alternatives to Chiauranib for Small Cell Lung Cancer patients include Lorlatinib, which has shown activity in ALK-positive NSCLC, and Aumolertinib, which is being explored as a treatment option after osimertinib failure in EGFR-sensitive mutations. Both drugs are currently under investigation and may offer new therapeutic options for SCLC patients.

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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

Patient has a diagnosis of histologically or cytologically confirmed advanced solid malignant tumor (including SCLC, NSCLC, colorectal carcinoma, hepatocellular carcinoma, ovarian cancer, neuroendocrine tumors, non-Hodgkin's lymphoma, or etc.) that has relapsed from or is refractory to standard therapy or for which no standard therapy exists

Must not have

History of active malignancy

Patients who are currently taking and have to continue taking specific drugs during Phase 1b of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called chiauranib for patients with advanced cancers that don't respond to standard treatments. It aims to block the signals that cancer cells need to grow. The focus is on patients with small cell lung cancer that has worsened after previous treatments.

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.

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.

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.

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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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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of cancer.

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I must continue taking certain medications during the study.

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I have been treated with specific inhibitors before.

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I understand and can follow the study's requirements.

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I am receiving treatment for interstitial lung disease.

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I have major issues with my digestive system.

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I have serious heart problems that are not under control.

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I have uncontrolled fluid buildup in my chest, heart, or abdomen.

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I have had a condition where my lymphocytes grow abnormally.

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I am currently experiencing active bleeding or have a high risk of bleeding in my stomach or intestines.

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I do not have active infections, hepatitis B or C, HIV/AIDS, or other serious infectious diseases.

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I am experiencing moderate to severe side effects from past treatments.

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I have or had other types of cancer.

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I need treatment for my brain metastases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence and characteristics of DLTs

Incidence of adverse events (AEs) and other safety parameters

MTD and recommended Phase 2 dose (RP2D)

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy, radiation therapy, and immunotherapy. Chemotherapy, often using drugs like etoposide combined with cisplatin or carboplatin, works by targeting rapidly dividing cancer cells, thereby reducing tumor size and spread. Radiation therapy uses high-energy rays to kill cancer cells and shrink tumors, often used in conjunction with chemotherapy for enhanced effectiveness. Immunotherapy, such as PD-1/PD-L1 inhibitors, helps the immune system recognize and attack cancer cells. Chiauranib, a multi-targeted kinase inhibitor, works by blocking multiple pathways involved in tumor growth and angiogenesis, offering a targeted approach that may overcome resistance seen with single-agent therapies. These treatments are crucial for SCLC patients due to the aggressive nature of the disease and its tendency to spread rapidly, necessitating a multifaceted treatment approach.

Caspase-9b Interacts Directly with cIAP1 to Drive Agonist-Independent Activation of NF-κB and Lung Tumorigenesis.Trials to Overcome Drug Resistance to EGFR and ALK Targeted Therapies - Past, Present, and Future.Tailoring tyrosine kinase inhibitors to fit the lung cancer genome.