Trial Search Results

An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer

The purpose of this study is to evaluate the objective response rate (complete response [CR]+ partial response [PR]) of the selected dose regimen in participants with metastatic or surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Janssen Research & Development, LLC

Stanford Investigator(s):

Intervention(s):

  • Drug: Erdafitinib

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Must have histologic demonstration of metastatic or surgically unresectable urothelial
   cancer. Minor components of variant histology such as glandular or squamous
   differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or
   micropapillary change are acceptable

   - Must have measurable disease according to the Response Evaluation Criteria in Solid
   Tumors (RECIST, version 1.1) at baseline

   - Must have an Eastern Cooperative Oncology Group (ECOG) performance status score 0, 1,
   or 2

   - Must have adequate bone marrow, liver, and renal function as described in protocol

   - Negative pregnancy test (urine or serum beta human chorionic gonadotropin [b-hCG]) at
   Screening for women of child bearing potential who are sexually active

   - Must have shown disease progression according to RECIST, version 1.1, following prior
   chemotherapy for metastatic or surgically unresectable urothelial cancer. Participants
   who received neoadjuvant or adjuvant chemotherapy and showed disease recurrence or
   progression according to RECIST, version 1.1, within 12 months of the last dose are
   considered to have received chemotherapy in the metastatic setting. These participants
   will be referred to as chemo-refractory participants. (Participants who have shown
   disease progression according to RECIST, version 1.1 following prior treatment with
   anti-Programmed death-ligand 1 (anti PDL1/PD1) antibodies are also eligible)

Exclusion Criteria:

   - Received chemotherapy, targeted therapies, definitive radiotherapy, or treatment with
   an investigational anticancer agent within 2 weeks (in the case of nitrosoureas and
   mitomycin C, within 6 weeks; in the case of immunotherapy, within 4 weeks) before the
   first administration of study drug. Localized palliative radiation therapy (but should
   not include radiation to target lesions) and ongoing bisphosphonates and denosumab,
   are permitted

   - Has persistent phosphate level greater than upper limit of normal (ULN) during
   screening (within 14 days of treatment and prior to Cycle 1 Day 1) and despite medical
   management

   - Has a history of or current uncontrolled cardiovascular disease

   - Females who are pregnant, breast-feeding, or planning to become pregnant within 3
   months after the last dose of study drug and males who plan to father a child while
   enrolled in this study or within 5 months after the last dose of study drug

   - Has not recovered from reversible toxicity of prior anticancer therapy (except
   toxicities which are not clinically significant such as alopecia, skin discoloration,
   or Grade 1 neuropathy)

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting