Cyclophosphamide Drug Interaction Study In Cancer Patients

GlaxoSmithKline (GSK)

Status and phase: Terminated; Phase 1

Conditions: Nausea and Vomiting, Chemotherapy-Induced

Treatments: Drug: IV Cyclophosphamide 500-700mg/m2; Drug: Oral GW679769

Study type: Interventional

Funder types: Industry

Identifiers

NCT00334646

NKV103444

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Arm A

Experimental group

Description:

cyclophosphamide + dexamethasone + ondansetron

Treatment:

Drug: IV Cyclophosphamide 500-700mg/m2

Arm B

Experimental group

Description:

cyclophosphamide + dexamethasone + ondansetron + GW679769

Treatment:

Drug: Oral GW679769