Continued Access to RXDX-105

NCT03784378 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 18-487
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer; Ovarian Cancer; RET Gene Mutation; BRAF Gene Mutation

Keywords

RXDX-105; Memorial Sloan Kettering Cancer Center; 18-487

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Participants previously enrolled on Study of RXDX-105

EXPERIMENTAL

Participants were previously enrolled on Study of RXDX-105

Drug: RXDX-105

Interventions

RXDX-105 DRUG

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.

Participants previously enrolled on Study of RXDX-105

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Any patients other than those described above are excluded.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center 1275 York Avenue

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Ovarian Neoplasms

Interventions

agerafenib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Alexander Drilon, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 21, 2018
• Study Start: December 14, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: May 15, 2025

Record last verified: 2020-09

Locations

US (1)