Avapritinib for the Treatment of CKIT or PDGFRA Mutation-Positive Locally Advanced or Metastatic Malignant Solid Tumors

Summary

This phase II trial studies the effect of avapritinib in treating malignant solid tumors that have a genetic change (mutation) in CKIT or PDGFRA and have spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Avapritinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Avapritinib may help to control the growth of malignant solid tumors.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Clinical Stage IV Gastroesophageal Junction Adenocarcinoma 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 Melanoma
• Locally Advanced Primary Malignant Central Nervous System Neoplasm
• Locally Advanced Sarcoma
• Metastatic Malignant Solid Neoplasm
• Metastatic Melanoma
• Metastatic Primary Malignant Central Nervous System Neoplasm
• Metastatic Sarcoma
• Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
• Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
• Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
• Prognostic Stage IIIC Breast Cancer AJCC v8
• Prognostic Stage IV Breast Cancer AJCC v8
• Stage IIIC Colorectal Cancer AJCC v8
• Stage IIIC Lung Cancer AJCC v8
• Stage IV Colorectal Cancer AJCC v8
• Stage IV Lung Cancer AJCC v8
• Stage IVA Colorectal Cancer AJCC v8
• Stage IVA Lung Cancer AJCC v8
• Stage IVB Colorectal Cancer AJCC v8
• Stage IVB Lung Cancer AJCC v8
• Stage IVC Colorectal Cancer AJCC v8

Interventions

DRUG

Avapritinib

Given PO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Jordi Rodon Ahnert · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-20

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States

Study Locations