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Cyclophosphamide Drug Interaction Study In Cancer Patients

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ClinicalTrials.gov Identifier: NCT00334646
Recruitment Status : Terminated (compound terminated)
First Posted : June 8, 2006
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Actual Study Start Date : August 10, 2005
Actual Primary Completion Date : October 14, 2009
Actual Study Completion Date : October 14, 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A
cyclophosphamide + dexamethasone + ondansetron
Drug: IV Cyclophosphamide 500-700mg/m2
IV Cyclophosphamide 500-700mg/m2 on day 1 of each cycle
Other Name: Oral GW679769

Experimental: Arm B
cyclophosphamide + dexamethasone + ondansetron + GW679769
Drug: Oral GW679769
150mg oral, once daily on days 1-3




Primary Outcome Measures :
  1. 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 :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334646


Locations
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United States, Delaware
GSK Investigational Site
Newark, Delaware, United States, 19713
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131
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
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00334646     History of Changes
Other Study ID Numbers: NKV103444
First Posted: June 8, 2006    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Cyclophosphamide
Casopitant
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents