Continued Access to RXDX-105

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03784378
• Other study ID #: 18-487
• Status: Completed
• Phase: Phase 1
• Start date: December 14, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: September 2020
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• BRAF Gene Mutation
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Ovarian Epithelial
• Lung Neoplasms
• Non Small Cell Lung Cancer
• Ovarian Cancer
• Ovarian Neoplasms
• RET Gene Mutation

Intervention

Drug:
• RXDX-105
RXDX-105 capsules will be administered orally on a continuous daily dosing regimen. Patients will be continue to be treated at the dose level they were previously treated on during participation on Study of RXDX-105.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center 1275 York Avenue	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation during treatment/intervention	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.	Through study completion, up to five years.

External Links

•   Memorial Sloan Kettering Cancer Center