A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493 in Adult Patients With Advanced or Refractory Solid Tumors or Lymphoma

Status: Recruiting
Diagnosis: Lung Cancer
NCT ID: NCT01703481 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 14-170


The purpose of this study is to evaluate the safety, pharmacokinetics (study of what the body does to a drug), and pharmacodynamics (study of what a drug does to the body) of JNJ-42756493, a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, in adult participants with advanced or refractory solid tumors or lymphoma.


Conducting Institutions:
Dana-Farber Cancer Institute

Overall PI:
Peter Hammerman, M.D., Ph.D, Dana Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Bryan Marion, bryan_marion@dfci.harvard.edu

Eligibility Criteria

Inclusion Criteria: - Histologically or cytologically confirmed: solid malignancy or lymphoma that is metastatic or unresectable, and for which standard curative treatment is no longer effective (Part 1); any type of advanced or refractory solid malignancy (excluding lymphoma) that is metastatic or unresectable and participants must be amenable to pre- and post-treatment biopsies (Part 2); advanced or refractory squamous non-small cell lung cancer (Cohort A, Part 3), advanced or refractory small cell lung cancer (Cohort B, Part 3), advanced or refractory breast cancer (Cohort C, Part 3), any type of advanced or refractory solid malignancy (excluding lymphoma) - Eastern Cooperative Oncology Group performance status score 0 or 1 - Adequate bone marrow, liver, and renal function within the 7 days prior to Day 1 of Cycle 1 of study drug - Serum electrolyte levels (magnesium, potassium) within 0.85 to 1.25 x institutional normal limits (within 7 days prior to Day 1 of Cycle 1) Exclusion Criteria: - Chemotherapy, targeted therapies, radiotherapy, immunotherapy, or treatment with an investigational anticancer agent within 3 weeks (in the case of nitrosoureas and mitomycin C within 6 weeks) before the first administration of study drug. Localized radiation therapy and ongoing luteinizing hormone-releasing hormone (LHRH) agonists, bisphosphonates and denosumab, are permitted - History or current condition of uncontrolled cardiovascular disease - Persistent calcium or phosphate greater than upper limit of normal during screening (within 7 days of treatment) and despite medical management of calcium or phosphate levels - Participants taking medications known to have a significant risk of causing QTc prolongation and Torsades de Pointes or known as strong CYP3A inhibitors or inducers - Left ventricular ejection fraction (LVEF) less than 48 percentage as assessed by echocardiography performed at screening - Any medical condition that requires intact wound healing capacity and is expected to endanger participant safety if wound healing capacity would be severely reduced during administration of the investigational agent - Participants 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)
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