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Clinical Trials/NCT03784378
NCT03784378CompletedPhase 1

RXDX-105 for the Treatment of Patients With Non-Small Cell Lung Cancer (NSCLC) Harboring a RET Gene Fusion and a Patient With Ovarian Cancer Harboring a BRAF Gene Mutation

Memorial Sloan Kettering Cancer Center1 site in 1 country3 target enrollmentStarted: December 14, 2018Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
3
Locations
1
Primary Endpoint
Evaluation during treatment/intervention

Study Overview

Brief Summary

This study is being done to see if people with Non-Small Cell Lung Cancer (NSCLC) or ovarian cancer benefit from continued treatment with the study drug, RXDX-105.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • This individual patient protocol includes treatment for 3 patients previously enrolled on IRB #15-270 (phase1/1b clinical trial RXDX-105-01):

Exclusion Criteria

  • Any patients other than those described above are excluded.

Arms & Interventions

Participants previously enrolled on Study of RXDX-105

Experimental

Participants were previously enrolled on Study of RXDX-105

Intervention: RXDX-105 (Drug)

Outcomes

Primary Outcomes

Evaluation during treatment/intervention

Time Frame: Through study completion, up to five years.

Safety assessments will be performed as standard of care and as clinically indicated. This will include monitoring of adverse events, including serious adverse events including CTCAE grading.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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