Avapritinib for the Treatment of CKIT or PDGFRA Mutation-Positive Locally Advanced or Metastatic Malignant Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Locally Advanced Melanoma
- Anatomic Stage IV Breast Cancer AJCC v8
- Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
- Stage IVB Lung Cancer AJCC v8
- Stage IIIC Colorectal Cancer AJCC v8
- Stage IIIC Lung Cancer AJCC v8
- Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Locally Advanced Malignant Solid Neoplasm
- Locally Advanced Primary Malignant Central Nervous System Neoplasm
- Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Prognostic Stage IV Breast Cancer AJCC v8
- Locally Advanced Sarcoma
- Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Stage IVA Colorectal Cancer AJCC v8
- Stage IVC Colorectal Cancer AJCC v8
- Prognostic Stage IIIC Breast Cancer AJCC v8
- Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
- Metastatic Malignant Solid Neoplasm
- Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Stage IV Colorectal Cancer AJCC v8
- Stage IVA Lung Cancer AJCC v8
- Stage IV Lung Cancer AJCC v8
- Metastatic Melanoma
- Metastatic Sarcoma
- Metastatic Primary Malignant Central Nervous System Neoplasm
- Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
- Stage IVB Colorectal Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR) of avapritinib in patients with pathogenic CKIT or PDGFRA activating mutation-positive malignant solid tumors, as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. SECONDARY OBJECTIVES: I. To evaluate the ...
PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR) of avapritinib in patients with pathogenic CKIT or PDGFRA activating mutation-positive malignant solid tumors, as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. SECONDARY OBJECTIVES: I. To evaluate the duration of response (DoR) to avapritinib in patients with pathogenic CKIT or PDGFRA activating mutation-positive malignant solid tumors. II. To evaluate the disease control rate (DCR) of avapritinib in patients with pathogenic CKIT or PDGFRA activating mutation-positive malignant solid tumors. III. To determine the safety and tolerability of avapritinib in patients with pathogenic CKIT or PDGFRA activating mutation-positive malignant solid tumors, as assessed by the National Cancer institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. EXPLORATORY OBJECTIVES: I. To evaluate the overall survival (OS) of patients with pathogenic CKIT or PDGFRA activating mutation-positive malignant solid tumors receiving avapritinib. II. To evaluate the ORR and DoR of avapritinib in patients with measurable brain or central nervous system (CNS) metastases at baseline. III. To evaluate the progression-free survival (PFS) of patients with pathogenic CKIT or PDGFRA activating mutation-positive malignant solid tumors receiving avapritinib. IV. To evaluate the correlation between genomic mutations and clinical outcome. V. To evaluate time on treatment (including patients treated beyond progression). VI. To evaluate baseline genomics and circulating cell-free deoxyribonucleic acid (cfDNA) and functional analyses of variants. OUTLINE: Patients receive avapritinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 8 weeks.
Tracking Information
- NCT #
- NCT04771520
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Jordi Rodon Ahnert M.D. Anderson Cancer Center
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