Phase 2 Study for the Patient, Who Has Diagnosed With Small Cell Lung Cancer (SCLC) or Non Small Cell Lung Cancer (NSCLC) or Renal Cell Carcinoma (RCC) and Finished the First Line Stand Treatment , Need More Treatment

Официальное название

A Phase 2 Evaluation of the Safety and Efficacy of Veonetinib (AL8326) in ≥2nd Line Small Cell Lung Cancer (SCLC), Non Small Cell Lung Cancer (NSCLC) and Renal Cell Carcinoma (RCC) Treatment

Обзор

This trial is a Phase II trial designed to evaluate the safety and efficacy of using oral AL8326 , a multi-targeted receptor Tyrosine Kinase Inhibitor( TKI) , to recurrent, advanced, or metastatic small cell lung cancer (SCLC) patients , Non-Small Cell Lung (NSCLC) and Renal Cell Carcinoma patients who need ≥2nd line treatment .

Подробное описание

This study is designed for two steps: Phase 2 Optimal Biological Dose (OBD) finding and Phase 2 expansion cohort study after OBD determination.

The Phase 2 study aims to find optimal biological dose (OBD) initially. Patients will be randomized to 3 different dosing groups in OBD finding cohorts. Each cohort will enroll 6-12 SCLC patients who need ≥2nd line treatment without or with brain metastasis which is controlled with no active hemorrhage. This OBD finding cohort will also evaluate the pharmacokinetic profile of AL8326.

OBD patient enrollment of 40 mg (n=12) and 60 mg (N=12) have been completed, waiting data maturing, 80 mg (n=4) has been stopped due to high intolerability. 40mg and 60mg cohort group can be expanded to an additional 6-12 patients in each cohort with only sparse PK sampling requirement if OBD is not able to be determined in early 12 patients of each cohort. Non-Small Cell Lung (NSCLC) and Renal Cell Carcinoma (RCC) are added to this protocol as additional expansion cohorts.

Вмешательства

• Препарат AL8326 40 mg
  Taken AL3826 at 40mg QD orally
• Препарат AL8326 60 mg
  Taken AL3826 at 60mg QD orally
• Препарат AL8326 80 mg--stopped
  Taken AL3826 at 80 mg QD orally

Первичные конечные точки

• Optimal biological dose ( OBD ) [Срок оценки: 12 months]
• Objective Response Rates (ORR) [Срок оценки: 12 month]
• ORR evaluation for NSCLC and RCC [Срок оценки: 24 month]

Вторичные конечные точки (4)

• Duration of response ( DOR) [Срок оценки: 36 month]
• Progression-Free Survival (PFS) [Срок оценки: 36 month]
• Pharmacokinetic endpoints [Срок оценки: 24 month]
• Pharmacokinetic endpoint Area Under the Curve (AUC) [Срок оценки: 24 month]

Критерии участия

Major Inclusion Criteria:

• Male or female, 18 years of age or older
• ECOG performance status of 0 or 1
• Histologically or cytologically confirmed SCLC /NSCLC/RCC
• Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1
• Have a life expectancy of at least 3 months

Major Exclusion Criteria:

• Serious, non-healing wound, ulcer or bone fracture
• Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to treatment
• Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
• Clinically significant cardiovascular disease including uncontrolled hypertension; myocardial infarction or unstable angina within 6 months prior to enrollment; New York Heart Association (NYHA) Grade II or greater congestive heart failure serious cardiac arrhythmia requiring medication; and Grade II or greater peripheral vascular disease
• Hemoptysis within 3 months prior to enrollment
• Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19 within 14 days prior to enrollment and during the study unless there is an emergent or life-threatening medical condition that required it.

More information available upon request

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 5 центров

• University of Alabama at Birmingham — Birmingham
• Cleveland Clinic Florida — Weston
• Northwestern University — Chicago
• Siteman Cancer Center, Washington University — St Louis
• Cleveland Clinic — Cleveland

Испания · 2 центра

• Hospital Universitari Vall d'Hebron — Barcelona
• Hospital Universitario Ramón Y Cajal — Madrid

Идентификаторы

NCT: NCT05363280 · AL8326-US-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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