Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 115
Summary
- Conditions
- Bronchial Neoplasms
- Adenocarcinoma
- Thoracic Neoplasms
- Neoplasms, Glandular and Epithelial
- Neuroectodermal Tumors
- Gastrointestinal Neoplasms
- Intestinal Disease
- RET-altered Colon Cancer
- RET-altered Papillary Thyroid Cancer
- Adenocarcinoma, Papillary
- Carcinoma
- Endocrine Gland Neoplasm
- RET-altered Solid Tumors
- Medullary Thyroid Cancer
- Respiratory Tract Neoplasms
- Neoplasms
- Carcinoma, Bronchogenic
- Digestive System Neoplasm
- Neoplasms by Histologic Type
- Neoplasms, Germ Cell and Embryonal
- Thyroid Neoplasm
- Carcinoma, Neuroendocrine
- Carcinoma Non-small-cell Lung
- Neoplasms, Nerve Tissue
- RET-altered Non Small Cell Lung Cancer
- Colonic Diseases
- Thyroid Cancer, Papillary
- Gastrointestinal Disease
- Lung Neoplasm
- Neoplasms by Site
- Intestinal Neoplasms
- Colonic Neoplasms
- Endocrine System Diseases
- Respiratory Tract Disease
- Neuroendocrine Tumors
- Head and Neck Neoplasms
- Thyroid Diseases
- Lung Diseases
- Colorectal Neoplasms
- Digestive System Disease
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Phase 1 (Complete): Advanced MTC, NSCLC or other solid tumor 30-600mg (PO QD or BID) Phase 2 (400mg QD): Group 1: RET fusion NSCLC previously treated with a platinum chemotherapy Group 2: RET fusion NSCLC not previously treated for metastatic disease Group 3: MTC previously treated with cabozantinib and/or vandetanib Group 4: MTC not previously treated with cabozantinib or vandetanib Group 5: Other solid tumors with a RET fusion not eligible for any of the other groups and previously treated with SOC or have no acceptable SOC for their tumor type as determined by the investigator Group 6: Any solid tumor with a RET alteration (fusion or mutation) previously treated with a selective RET Inhibitor Group 7: Other solid tumors with a RET mutation previously treated with SOC Group 8: RET fusion NSCLC previously treated with a platinum chemotherapy (China only) Group 9: MTC not previously treated with systemic therapy for advanced or metastatic disease (China only) Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The study consists of 2 parts, a dose-escalation part (Phase 1) and an expansion part (Phase 2). Both parts will enroll patients with advanced non-resectable NSCLC, advanced non-resectable thyroid cancer and other advanced solid tumors that have progressed following standard systemic therapy, have n...
The study consists of 2 parts, a dose-escalation part (Phase 1) and an expansion part (Phase 2). Both parts will enroll patients with advanced non-resectable NSCLC, advanced non-resectable thyroid cancer and other advanced solid tumors that have progressed following standard systemic therapy, have not adequately responded to standard systemic therapy, or the patients must be intolerant to or the Investigator has determined that treatment with standard therapy is not appropriate, or there must be no accepted standard therapy for their disease.
Tracking Information
- NCT #
- NCT03037385
- Collaborators
- Not Provided
- Investigators
- Study Director: Clinical Trials Hoffmann-La Roche
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