Status:
COMPLETED
Phase 1 Study of CEP-37250/KHK2804 in Subjects With Advanced Solid Tumors
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Collaborating Sponsors:
Teva Pharma
Kyowa Hakko Kirin Pharma, Inc.
Conditions:
Solid Tumour
Adenocarcinoma of the Colorectal
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a two-part, Phase 1 open label, multi-center, dose escalation study of CEP-37250/KHK2804 as monotherapy in subjects with advanced solid tumors who no longer respond to standard therapy or for ...
Detailed Description
The study will be conducted in two parts. In Part 1, a standard 3+3 designed dose escalation phase, subjects will receive CEP-37250/KHK2804, administered iv, once every week. A treatment cycle will co...
Eligibility Criteria
Inclusion
- Adequate hepatic, renal, and hematologic function;
- Life expectancy \> 3 months;
- Part 1 and 2: The subject has histopathologically or cytologically documented, measurable, unresectable, locally advanced primary or recurrent, metastatic solid tumor, locally advanced primary or recurrent, metastatic pancreatic adenocarcinoma and must have received at least one prior treatment regimen containing gemcitabine or 5-FU, and locally advanced primary or recurrent, metastatic colon adenocarcinoma.
Exclusion
- Parts 1 and 2:
- Malignant melanoma, Merkel cell cancer, small cell lung cancer, lymphoepithelial carcinoma, malignant mesothelioma, GIST, Hodgkin and NHL, thymoma, neuroendocrine, neuronal tumors, and sarcomas. This list of excluded tumors may be modified as additional research findings become available on target antigen expression;
- The subject has received anti-cancer chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks (6 weeks for mitomycin C and nitrosoureas) prior to the first dose of CEP-37250/KHK2804;
- The subject has received monoclonal antibodies of any type or for any form of disease within 4 weeks of the first dose of CEP-37250/KHK2804;
- Major surgery within 4 weeks prior to the first dose;
- Known symptomatic brain metastases (screening magnetic resonance imaging (MRI) of the brain is only required when there is clinical suspicion of central nervous system \[CNS\] involvement or past history of treated brain metastasis). Subjects with treated brain metastasis (radiotherapy and/or surgery) will be eligible if they:
- Have completed treatment for their brain metastasis \> 4 weeks prior to scheduled study treatment start date;
- Are neurologically stable;
- Are on corticosteroids in doses no greater than physiological replacement (e.g., dexamethasone \< 1.5 mg/day); and
- Have a screening MRI scan of the brain that specifically verifies no evidence of CNS hemorrhage and no active gadolinium enhancing lesions;
- Subjects with primary brain/CNS malignancy (e.g., gliomas, lymphomas) are excluded.
- Hypersensitivity reaction to monoclonal antibodies, other therapeutic proteins, or allergy to any component of the CEP-37250/KHK2804 finished drug and the reaction could not be controlled or prevented on subsequent infusion with standard therapies such as antihistamines, 5-HT3 antagonists, or corticosteroids.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01447732
Start Date
October 1 2011
End Date
January 1 2015
Last Update
April 29 2024
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