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Expanded Access Program (EAP) for Participants With Advanced Cancers and Fibroblast Growth Factor Receptor (FGFR) Genetic Alterations Who Have Exhausted All Treatment Options

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ClinicalTrials.gov Identifier: NCT03825484
Expanded Access Status : Approved for marketing
First Posted : January 31, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

Tracking Information
First Submitted Date January 29, 2019
First Posted Date January 31, 2019
Last Update Posted Date May 13, 2019
 
Descriptive Information
Brief Title Expanded Access Program (EAP) for Participants With Advanced Cancers and Fibroblast Growth Factor Receptor (FGFR) Genetic Alterations Who Have Exhausted All Treatment Options
Brief Summary The purpose of this program is to provide participants an early access to erdafitinib prior to market authorization (that is, Food and Drug Administration [FDA] approval in the United States). The program is limited to participants with advanced cancers and fibroblast growth factor receptor (FGFR) genetic alterations who have exhausted at least 2 lines of standard of care therapy and who are not eligible for an erdafitinib clinical trial.
Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Intermediate-size Population
Intervention Drug: Erdafitinib
Participants will start erdafitinib 8 milligram (mg) (formulated as tablets with 3 mg, 4 mg and 5 mg dosages) orally once daily until disease progression, intolerable toxicity, withdrawal of consent or decision by the doctor to discontinue treatment. Dose will be up-titrated to 9 mg based on serum phosphate levels and if there is no drug-related toxicity.
Other Name: JNJ-42756493
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Approved for marketing
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03825484
Responsible Party Janssen Scientific Affairs, LLC
Study Sponsor Janssen Scientific Affairs, LLC
Collaborators Not Provided
Investigators
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
PRS Account Janssen Scientific Affairs, LLC
Verification Date May 2019