Study of Satraplatin With Capecitabine to Treat Advanced Solid Malignancies

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Agennix
• Treatments: Capecitabine; Satraplatin

Criteria

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