Study of Satraplatin With Capecitabine to Treat Advanced Solid Malignancies

Phase 1 Study of the Oral Platinum Agent Satraplatin in Combination With Capecitabine for the Treatment of Patients With Advanced Solid Malignancies

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.

This is a single center, open-label, non-randomized, Phase I dose finding study of the investigational, oral cytotoxic drug, satraplatin in combination with capecitabine in patients with advanced solid tumors for whom curative therapy is not available. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria.

PURPOSE: The purpose of this trial is to determine a tolerable dose and schedule for the combination of satraplatin and docetaxel when given to patients with advanced solid tumors.

WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.

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