NCT01032681

EMD 521873 in Advanced Solid Tumors, MTD Finding

A Phase 1, Open-Label, Two-Group, Dose- Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of EMD 521873 Alone and in Combination With Fixed Low Doses of Cyclophosphamide in Patients With Metastatic or Locally Advanced Solid Tumors or B-Cell Non-Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary trial objective in this three arm trial is to assess the safety and tolerability of EMD 521873, and to determine whether the maximum tolerated dose (MTD) is reached with EMD 521873 doses of up to 1.5 mg/kg given alone or in combination with fixed, low-dose cyclophosphamide (CPA) in patients with metastatic or locally advanced solid tumors or B-cell non-Hodgkin lymphoma. Secondary objectives are to evaluate pharmacokinetic, immunogenicity, overall and best clinical response, changes in tumor marker levels, survival and biological/immune responses to EMD 521873. A total of 78 patients are planned. Patients will remain on the dose throughout the trial. It is intended to administer 3 cycles (21 d each, or until progression or a xxx line therapy becomes necessary.

Conditions

• Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	EMD 521873	Dose escalation steps: Group 1: 0,075mg/kg - 0,15mg/kg - 0,225mg/kg - 0,3mg/kg - 0,45mg/kg - 0,6mg/kg - 0,9mg/kg (-1,8mg/kg - 2,1mg/kg - 2,5mg/kg - 3,0mg/kg) Disease control and decision of continuation in patient who benefit from the treatment: Every second cycle
BIOLOGICAL	EMD 521873	Dose escalation steps: Group 2: CPA plus 0,6mg/kg - 0,9mg/kg Disease control and decision of continuation in patient who benefit from the treatment: Every second cycle
BIOLOGICAL	EMD 521873	Dose escalation steps: Group 3: 0,9mg/kg - 1,2mg/kg - 1,5mg/kg (-1,8mg/kg - 2,1mg/kg - 2,5mg/kg - 3,0mg/kg) Disease control and decision of continuation in patient who benefit from the treatment: Every second cycle

Timeline

• Start date: 2006-12-01
• Primary completion: 2011-02-01
• Completion: 2012-01-01
• First posted: 2009-12-15
• Last updated: 2014-07-31

Locations

5 sites across 2 countries: Germany, Switzerland