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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

Study Description
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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.

Condition or disease Intervention/treatment
Advanced Cancers and FGFR Genetic Alterations Drug: Erdafitinib

Study Design
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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access Program (EAP) for Patients With Advanced Cancers and FGFR Genetic Alterations Who Have Exhausted All Treatment Options

Resource links provided by the National Library of Medicine

Drug Information available for: Erdafitinib

Interventions
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Intervention Details:
  • 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
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Participant has a documented fibroblast growth factor receptor (FGFR) alteration
  • Participant does not have co-morbidities that would alter risk-benefit of providing erdafitinib (determined by treating physician's assessment)
  • Life expectancy is greater than (>) 3 months (determined by treating physician's assessment)
  • Participant has exhausted treatment options for their disease (review of prior treatments)
  • Participant is not eligible for other erdafitinib clinical trials including but not limited to BLC3001/NCT03390504 and BLC2002/NCT03473743
Contacts and Locations
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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): NCT03825484


Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Investigators
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Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
More Information
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Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT03825484    
Other Study ID Numbers: CR108489
42756493MAF4001 ( Other Identifier: Janssen Scientific Affairs, LLC )
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Neoplasms