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Cyclophosphamide Drug Interaction Study In Cancer Patients

This study has been terminated.
(compound terminated)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00334646
First received: June 6, 2006
Last updated: July 26, 2012
Last verified: July 2012
History of Changes
  Purpose

This study is designed to evaluate the potential pharmacokinetic interaction between oral GW679769 and IV (intravenous) cyclophosphamide when administered to cancer patients.


Condition Intervention Phase
Nausea and Vomiting, Chemotherapy-Induced
Cancer
 Drug: Oral GW679769
Drug: IV Cyclophosphamide 500-700mg/m2
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Repeat Dose, Randomized, Two Period Crossover Study to Investigate the Potential Pharmacokinetic Interactions Between Oral GW679769 and Intravenous Cyclophosphamide in Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Cmax and AUC of cyclophosphamide and 4-hydroxycyclophosphamideSafety and tolerability parameters including pharmacoeconomics, blood pressure, heart rate, ECG, laboratory tests, clinical observation and adverse event reporting. [ Time Frame: throughout the study ]

Secondary Outcome Measures:
  • Terminal t1/2, Vd, and Cl of cyclophosphamideTerminal t1/2 of 4-hydroxycyclophosphamideAUC ratio of 4-hydroxycyclophosphamide and cyclophosphamideANC nadir [ Time Frame: throughout the study ]

Enrollment: 10
Study Start Date: August 2005
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
cyclophosphamide + dexamethasone + ondansetron
 Drug: IV Cyclophosphamide 500-700mg/m2
IV Cyclophosphamide 500-700mg/m2 on day 1 of each cycle
Other Names:
  • Oral GW679769
  • IV Cyclophosphamide 500-700mg/m2
Experimental: Arm B
cyclophosphamide + dexamethasone + ondansetron + GW679769
 Drug: Oral GW679769
150mg oral, once daily on days 1-3

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of cancer.
  • Undergoing chemotherapy with a cyclophosphamide regimen with a cyclophosphamide dose of 500 - 700 mg/m2 and a cycle duration of 14-28 days.
  • Adequate hematologic, renal and hepatic function.

Exclusion Criteria:

  • Pregnant or lactating.
  • CNS (central nervous system) metastases.
  • Active systemic infection or any other poorly controlled medical condition.
  • Patients cannot take CYP3A4 inhibitors within 7 days of study treatment or CYP3A4 inducers within 48 days of study treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00334646

Locations
United States, Delaware
GSK Investigational Site
Newark, Delaware, United States, 19713
United States, New York
GSK Investigational Site
Bronx, New York, United States, 10461
New Zealand
GSK Investigational Site
Christchurch, New Zealand, 8011
Sweden
GSK Investigational Site
Lund, Sweden, SE-221 85
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00334646     History of Changes
Other Study ID Numbers: NKV103444
Study First Received: June 6, 2006
Last Updated: July 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
cyclophosphamide
CINV
Chemotherapy induced nausea and vomiting

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on October 16, 2012