An Efficacy and Safety Study of JNJ-42756493 in Participants with Urothelial Cancer

Phase 1

• Conditions: rothelial cancer; MedDRA version: 20.0 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-002408-26-AT
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-21
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 180

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 [bhCG]) 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. Subjects 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 subjects will be
referred to as chemorefractory
subjects. (Subjects who have shown disease progression according to RECIST, version 1.1 following prior treatment with antiProgrammed
deathligand 1 (anti PDL1/PD1) antibodies are also eligible)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 126

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, breastfeeding, 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified