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Continued Access to RXDX-105

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ClinicalTrials.gov Identifier: NCT03784378
Expanded Access Status : Available
First Posted : December 21, 2018
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Ovarian Cancer RET Gene Mutation BRAF Gene Mutation Drug: RXDX-105

Study Type : Expanded Access
Expanded Access Type : Individual Patients, Treatment IND/Protocol
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



Intervention Details:
  • 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • This individual patient protocol includes treatment for 4 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03784378


Contacts
Contact: Alexander Drilon, MD 646-888-4206 drilona@mskcc.org
Contact: David Hyman, MD 646-888-4544 hymand@mskcc.org

Locations
United States, New York
Memorial Sloan Kettering Cancer Center 1275 York Avenue
New York, New York, United States, 10065
Contact: Alexander Drilon, MD    646-888-4206      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Alexander Drilon, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03784378     History of Changes
Other Study ID Numbers: 18-487
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019

Keywords provided by Memorial Sloan Kettering Cancer Center:
RXDX-105
Memorial Sloan Kettering Cancer Center
18-487

Additional relevant MeSH terms:
Lung Neoplasms
Ovarian Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Bronchial Neoplasms
Endocrine Gland Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders