A Study to Test the Effect of the Drug Larotrectinib in Adults With NTRK-fusion Positive Solid Tumors (NAVIGATE)

Phase 2

• Conditions: Health Condition 1: D493- Neoplasm of unspecified behavior of breast

• Registration Number: CTRI/2021/07/034739
• Lead Sponsor: Bayer Consumer Care AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Locally advanced or metastatic non-secretory breast cancer, lung cancer, melanoma, and colorectal cancer with unknown human neurotrophic tyrosine receptor kinase 1 (NTRK1), NTRK2, or NTRK3 fusion status.

Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy.

Subjects must have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Exclusion Criteria

Prior progression while receiving approved or investigational tyrosine kinase

inhibitors targeting TRK. Subjects who received less than 28 days of treatment and

discontinued because of intolerance or toxicity are eligible.

Symptomatic or unstable brain metastases. (Note: Subjects with asymptomatic brain

metastases are eligible to participate in the study.) Subjects with primary CNS tumors

are eligible.

Unstable cardiovascular disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified