Advanced Cancers and FGFR Genetic AlterationsNCT03825484
Expanded Access Program (EAP) for Participants With Advanced Cancers and Fibroblast Growth Factor Receptor (FGFR) Genetic Alterations Who Have Exhausted All Treatment Options
A study testing Erdafitinib in people with Advanced Cancers and FGFR Genetic Alterations, run by Janssen Scientific Affairs, LLC.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Cancers and FGFR Genetic Alterations
- What is being tested?
- Erdafitinib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
About this study
Official title: Expanded Access Program (EAP) for Patients With Advanced Cancers and FGFR Genetic Alterations Who Have Exhausted All Treatment Options
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.
- Being tested
- Erdafitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErdafitinibDrug
Also called JNJ-42756493
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Cancers and FGFR Genetic AlterationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Janssen Scientific Affairs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Scientific Affairs, LLC Clinical Trial, Study director, Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825484
- Sponsor's protocol ID
- CR108489
- Other IDs
- 42756493MAF4001
- Status last verified
- Jun 2025
- First submitted
- 29 Jan 2019
- Last updated
- 13 Jun 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program (EAP) for Patients With Advanced Cancers and FGFR Genetic Alterations Who Have Exhausted All Treatment Options
- ClinicalTrials.gov ID
- NCT03825484
- Acronym / sponsor ID
- CR108489
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErdafitinibAlso: JNJ-42756493Participants 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. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
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Active, not recruitingPhase 1/2
A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Scientific Affairs, LLC Clinical Trial study director
Janssen Scientific Affairs, LLC
Questions about this trial
What is this clinical trial studying?
A study testing Erdafitinib in people with Advanced Cancers and FGFR Genetic Alterations, run by Janssen Scientific Affairs, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.