Clinical trial · Interventional
Cyclophosphamide Drug Interaction Study In Cancer Patients
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
NCT00334646CI-TRIAL-00030386terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): compound terminated
Summary
Brief summary (as posted)
This study is designed to evaluate the potential pharmacokinetic interaction between oral GW679769 and IV (intravenous) cyclophosphamide when administered to cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nausea and Vomiting, Chemotherapy-Induced | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IV Cyclophosphamide 500-700mg/m2 | Drug | Cyclophosphamide | ALIAS |
| Oral GW679769 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- cyclophosphamide + dexamethasone + ondansetron
- interventionNames
- Drug: IV Cyclophosphamide 500-700mg/m2
- type
- EXPERIMENTAL
- label
- Arm B
- description
- cyclophosphamide + dexamethasone + ondansetron + GW679769
- interventionNames
- Drug: Oral GW679769
Primary outcomes (1)
- measure
- 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.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.