Study of Satraplatin With Capecitabine to Treat Advanced Solid Malignancies

NCT00329329 | Terminated Phase 1

• 1 other identifier: SAT1-05-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignancies

Keywords

Advanced solid malignancies

Outcome Measures

Primary Outcomes (1)

• MTD

  2007

Secondary Outcomes (1)

• Safety

  2007

Interventions

satraplatin and capecitabine DRUG

satraplatin and capecitabine dose escalated per the dosing scheme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Agennix: lead

Study Sites (1)

Northwestern University Medical Center

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

satraplatin; Capecitabine

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• William Gradishar, MD

  Northwestern University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2006
• First Posted: May 24, 2006
• Study Start: May 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: February 1, 2009
• Last Updated: March 23, 2012

Record last verified: 2012-03

Locations

US (1)