Back to resultsContinued Access to RXDX-105
Primary Purpose
Non Small Cell Lung Cancer, Ovarian Cancer, RET Gene Mutation
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RXDX-105
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring RXDX-105, Memorial Sloan Kettering Cancer Center, 18-487
Eligibility Criteria
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.
Sites / Locations
- Memorial Sloan Kettering Cancer Center 1275 York Avenue
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants previously enrolled on Study of RXDX-105
Arm Description
Participants were previously enrolled on Study of RXDX-105
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03784378
First Posted
December 17, 2018
Last Updated
September 30, 2020
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT03784378
Brief Title
Continued Access to RXDX-105
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 14, 2018 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, Ovarian Cancer, RET Gene Mutation, BRAF Gene Mutation
Keywords
RXDX-105, Memorial Sloan Kettering Cancer Center, 18-487
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participants previously enrolled on Study of RXDX-105
Arm Type
Experimental
Arm Description
Participants were previously enrolled on Study of RXDX-105
Intervention Type
Drug
Intervention Name(s)
RXDX-105
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation during treatment/intervention
Description
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.
Time Frame
Through study completion, up to five years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Drilon, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center 1275 York Avenue
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
Continued Access to RXDX-105
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