Study of Satraplatin With Capecitabine to Treat Advanced Solid Malignancies

This study has been terminated.
(Sponsor decided to discontinue study drug development)
Sponsor:
Information provided by (Responsible Party):
Agennix
ClinicalTrials.gov Identifier:
NCT00329329
First received: May 22, 2006
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Malignancies
Drug: satraplatin and capecitabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of the Oral Platinum Agent Satraplatin in Combination With Capecitabine for the Treatment of Patients With Advanced Solid Malignancies

Resource links provided by NLM:


Further study details as provided by Agennix:

Primary Outcome Measures:
  • MTD [ Time Frame: 2007 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 2007 ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: May 2006
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: satraplatin and capecitabine
    satraplatin and capecitabine dose escalated per the dosing scheme
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329329

Locations
United States, Illinois
Northwestern University Medical Center
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Agennix
Investigators
Principal Investigator: William Gradishar, MD Northwestern University Medical Center
  More Information

No publications provided

Responsible Party: Agennix
ClinicalTrials.gov Identifier: NCT00329329     History of Changes
Other Study ID Numbers: SAT1-05-02
Study First Received: May 22, 2006
Last Updated: March 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Agennix:
Advanced solid malignancies

Additional relevant MeSH terms:
Neoplasms
Capecitabine
Fluorouracil
Satraplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014