Neoplasms, Lymphoma, Adenocarcinoma Esophagogastric Junction
Conditions
Interventions
investigational material(s)
Generic name etc : JNJ-42756493
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational mate
Sponsors
Janssen Pharmaceutical K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part 1: - Histologically or cytologically confirmed solid malignancy or lymphoma that is metastatic or unresectable, and for which standard curative treatment is no longer effective Part 2: - Histologically or cytologically confirmed gastric adenocarcinoma including gastroesophageal junctions that is metastatic, locally advanced or unresectable, and for which standard treatment is no longer effective or tolerable - Eastern Cooperative Oncology Group performance status score 0 or 1 - Adequate bone marrow, liver, and renal function according to protocol-defined criteria within the 7 days prior to Day 1 of Cycle 1 - Laboratory values within protocol-defined parameters - Agrees to protocol-defined use of effective contraception - Negative urine pregnancy test at screening for women of child bearing potential
Exclusion criteria
Exclusion criteria: - Has had chemotherapy, radiotherapy, immunotherapy, or treatment with an investigational anticancer agent within 3 weeks (nitrosoureas and mitomycin C within 6 weeks) before the first administration of study drug (localized radiation therapy for palliative purposes and ongoing luteinizing hormone-releasing hormone agonists and antagonists for patients with prostate cancer, bisphosphonates and denosumab are permitted - History or current condition of uncontrolled cardiovascular disease as defined in the protocol - Taking medications known to have a risk of causing QTc prolongation and Torsades de Pointes or known as strong CYP3A inhibitors or inducers - Left ventricular ejection fraction less than (<) 50 percent (%) as assessed by echocardiography performed at screening - Uncontrolled intercurrent illness including, but not limited to, poorly controlled hypertension or diabetes, ongoing active infection, psychiatric illness, or a risk of gastrointestinal perforation - Woman who is pregnant, breast-feeding, or planning to become pregnant or a man who plans to father a child while enrolled in this study or within 3 months after the last dose of study drug - Not recovered from reversible, clinically significant toxicity of prior anticancer therapy - Presence of 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 - Major surgery within 4 weeks before enrollment - Known human immunodeficiency virus infection - Known hepatitis B or C (except hepatocellular carcinoma) - Active, symptomatic, or untreated brain metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT) Up to 30 days after the last dose of study medication | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum/Minimum observed plasma concentration of JNJ-42756493 Up to Part 2 Cycle 4 (each cycle is 28 days) Day 1 Time correspondent to the maximum observed plasma concentration of JNJ-42756493 Up to Part 2 Cycle 4 (each cycle is 28 days) Day 1 Area under the plasma concentration-time curve from time 0 to 24 hours of JNJ-42756493 Up to Part 2 Cycle 4 (each cycle is 28 days) Day 1 Half-life of JNJ-42756493 Up to Part 2 Cycle 4 (each cycle is 28 days) Day 1 Apparent volume of distribution of JNJ-42756493 Up to Part 2 Cycle 4 (each cycle is 28 days) Day 1 Total clearance of drug of JNJ-42756493 Up to Part 2 Cycle 4 (each cycle is 28 days) Day 1 Accumulation index of JNJ-42756493 Up to Part 2 Cycle 4 (each cycle is 28 days) Day 1 Number of participants with complete/partial response Up to Part 2 Cycle 4 (each cycle is 28 days) Day 1 Number of participants with stable / progressive disease Up to Part 2 Cycle 4 (each cycle is 28 days) Day 1 | — |
Outcome results
None listed