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A Phase 1 Study to Estimate MMAE Metabolites in Human Plasma and Urine in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma or Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma Receiving Brentuximab Vedotin
This is an open-label trial to estimate the concentrations of brentuximab vedotin in relapsed/refractory Hodgkin lymphoma (HL) or relapsed/refractory systemic anaplastic large cell lymphoma (sALCL) participants treated with either brentuximab vedotin or brentuximab vedotin + rifampicin.
Details
| Lead sponsor | Millennium Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 20 |
| Start date | 2013-11 |
| Completion | 2015-06 |
Conditions
- Hodgkin Lymphoma
- Anaplastic Large-cell Lymphoma
Interventions
- brentuximab vedotin
- Brentuximab vedotin and rifampicin
Primary outcomes
- Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose — Cycle 1: Predose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The lower limit of Quantification (LLQ) for all the observations was 0.01 nanogram/milliliter (ng/mL). - Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose — Cycle 2: Predose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. - Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose — Cycle 3: Predose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. - Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose — Cycle 1: 0.5 hour postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. - Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose — Cycle 2: 0.5 hour postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. - Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose — Cycle 3: 0.5 hour postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Countries
Belgium, Lithuania, Spain