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Dose-Escalating Study Of SB-485232 Administered Intravenously Every 28 Days To Adults With Solid Tumors Or Lymphomas

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ClinicalTrials.gov Identifier: NCT00085904
Recruitment Status : Completed
First Posted : June 18, 2004
Last Update Posted : October 13, 2008
Sponsor:
Information provided by:
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE June 16, 2004
First Posted Date  ICMJE June 18, 2004
Last Update Posted Date October 13, 2008
Study Start Date  ICMJE April 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2007)
Evaluation of adverse events and changes in laboratory values. The potential dose is a dose regimen with no more than 2 out of 6 patients experiencing a dose-limiting toxicity. [ Time Frame: 6 Months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00085904 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2007)
Evaluation for the presence of anti-SB-485232 antibodies, IL-18 neutralizing activity, and clinical sequelae. Pharmacokinetic endpoints are AUC, Cmax, Cmin, CL,Vss, and t1/2. Flow cytometry data. Assessments of disease. [ Time Frame: 6 Months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose-Escalating Study Of SB-485232 Administered Intravenously Every 28 Days To Adults With Solid Tumors Or Lymphomas
Official Title  ICMJE A Phase I, Dose-Escalation Study to Assess the Safety and Pharmacokinetics of SB- 485232 Administered as Five Daily Intravenous Infusions Repeated Every 28 Days in Adult Patients With Solid Tumors and Lymphomas
Brief Summary SB-485232 will be administered as five daily intravenous (IV) infusions repeated every 28 days in adult subjects with advanced solid tumors or lymphomas. Subjects may receive up to 6 cycles of treatment unless progressive disease or unacceptable toxicity is noted. Three dose levels of drug will be investigated. Safety evaluations, including blood sampling for various laboratory tests, will be conducted. Additional blood samples will also be taken to measure the amount of drug in the body at specific times.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor Cancer
  • Lymphoma
Intervention  ICMJE Drug: SB-485232
Study Arms Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2006)
12
Original Enrollment  ICMJE Not Provided
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Histopathological confirmation of cancer limited to a solid tumor malignancy or follicular lymphoma.
  • Advanced or metastatic disease.
  • Measurable disease.
  • Females of child-bearing potential must use adequate birth control.
  • Karnofsky Performance Status of 70% or greater.
  • Predicted life expectancy of at least 12 weeks in the estimation of the physician conducting the study (Principal Investigator).
  • Adequate laboratory results.
  • Subjects with history of coronary artery disease must have a stress test without clinically significant abnormalities.
  • Subjects with a history of congestive heart failure, myocardial infarction or prior anthracycline chemotherapy, must have a MUGA (Multiple Gated Acquisition) scan which demonstrates a left ventricular ejection fraction equal to or greater than 40%.
  • Signed informed consent form

Exclusion Criteria:

  • Female subject is pregnant or nursing (lactating).
  • Active, chronic or uncontrolled infections requiring systemic antibiotic therapy.
  • Serious medical or psychiatric disorder that would interfere with the subject''s safety or ability to sign the informed consent.
  • Leptomeningeal disease or evidence of prior or current metastatic brain disease.
  • Receiving concurrent chemotherapy, immunotherapy, radiotherapy, corticosteroid therapy, or investigational therapy.
  • Received chemotherapy, radiotherapy, immunotherapy, hormonal therapy or biological therapy for cancer or underwent a surgical procedure (except for minor surgical procedures) within 4 weeks before beginning treatment with SB-485232 (6 weeks in case of nitrosureas or mitomycin C).
  • Exposed to an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of SB-485232.
  • Severe concurrent disease or condition, including clinically significant autoimmune disease, which in the judgement of the physician conducting the study (the principal investigator) would render the patient inappropriate for study participation.
  • History of ventricular arrhythmias requiring drug or device therapy.
  • An unresolved or unstable, serious toxicity from prior administration of another investigational product.
  • Psychological, familial, sociological, or geographical limitations that do not permit compliance with this protocol.
  • Received prior SB-485232 therapy.
  • Poor venous access.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00085904
Other Study ID Numbers  ICMJE 485232/003
003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Study Director, GSK
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP