Malignancies Clinical Trial
Official title:
Phase 1 Study of the Oral Platinum Agent Satraplatin in Combination With Capecitabine for the Treatment of Patients With Advanced Solid Malignancies
Verified date | March 2012 |
Source | Agennix |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine the maximally tolerated dose (MTD) and Phase 2 recommended dose of satraplatin when administered in combination with capecitabine in patients with advanced solid malignancies.
Status | Terminated |
Enrollment | 24 |
Est. completion date | February 2009 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Key Inclusion Criteria: - Histologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative chemotherapy measures do not exist or are no longer effective - Age > 18 years old - ECOG Performance Status < 2 - Female patients may not be pregnant or lactating and must be willing to practice contraception - Adequate organ function as defined by the following: - Serum creatinine < 1.5 mg/dl - Absolute neutrophil count (ANC) > 1500/dL - Platelets > 100,000/dL - Total bilirubin < upper limit of normal (ULN) for the reference lab - AST, ALT, and alkaline phosphatase must be within the designated range allowing for eligibility Key Exclusion Criteria: - Other chemotherapy treatment < 4 weeks prior to enrollment Treatment with capecitabine, 5-fluorouracil (5-FU), or a platinum agent < 3 months from time of enrollment - Radiotherapy involving > 30% of the active bone marrow - Radiotherapy < 4 weeks prior to enrollment - Pre-existing peripheral neuropathy > grade 1 - Pre-existing hearing loss > grade 2 - Metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, had a negative imaging study within 4 weeks of study entry, is clinically stable with respect to the tumor at the time of study entry, and is not receiving steroid therapy or taper - Patients who have not recovered (> grade 1) from the following toxicities of previous regimens before enrollment: - hematologic toxicities - fatigue - mucositis - nausea/vomiting - diarrhea - Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation) - Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, uncontrolled congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements - History of hypersensitivity reaction to capecitabine, 5-FU or any platinum containing drugs - History of human immunodeficiency (HIV) or acquired immunodeficiency syndrome (AIDS) related illness - Evidence of concurrent second malignancy other than basal cell carcinoma of the skin or cervical carcinoma in situ - Concurrent use of medications that inhibit cytochrome P450 3A4 (including aprepitant) - History of bone marrow or major organ transplant |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University Medical Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Agennix |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MTD | 2007 | Yes | |
Secondary | Safety | 2007 | Yes |
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