News von der Partnerpipeline!
Nachdem Novartis mit dem Morphosys-anti-DKK1 MAb BHQ880 seit Herbst letzten Jahres gegen solide Tumore in der P1 sei, will Novartis mit dem gleichen AK im Dezember in eine P1b/P2 Kombistudie starten:
A Phase Ib/II Multicenter Study With an Adaptive Randomized, Dose-Determination, Placebo-Controlled, Double-Blind Phase II, to Assess the Safety, Efficacy, Tolerability, PK, and PD of Various Repeated IV Doses of BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients
This study is not yet open for participant recruitment.
Verified by Novartis, August 2008
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00741377
Purpose
This study has two portions, a phase I portion and a phase II portion. The purpose of the phase I portion is to assess the maximum-tolerated dose (MTD) and to characterize dose limiting toxicity (DLT) of escalating doses of BHQ880 (up to a maximum dose of 20 mg/kg) in combination with standard chemotherapy and zoledronic acid in relapsed or refractory multiple myeloma patients.
The phase II portion of the study will also be conducted in relapsed or refractory multiple myeloma patients. Patients will be treated with various doses of BHQ880 or placebo in combination standard chemotherapy. In the phase II portion of the study zoledronic acid will be added after the first 28 days of therapy with BHQ880 or placebo and standard chemotherapy. This will allow any BHQ880-related changes in bone biomarkers to be detected in a zoledronic acid-free environment. The purpose of the phase II portion of the study, is to determine one or more doses of BHQ880 for further development based on dose-efficacy modeling. Efficacy is defined as time to first skeletal-related event and change in bone markers for bone resorption and formation relative to placebo. A skeletal-related event is defined as:
Pathologic fracture
Spinal cord compression
Requirement for either radiation or surgery to bone due to:
Pain
Prevention of imminent fracture
Stabilization of a fracture Biomarker and imaging endpoints will be assessed in both phases of the study. The pharmacodynamic effects of BHQ880 will be assessed by measuring biochemical markers of bone formation, resorption, and metabolism in serum and urine. Charges in serum DKK1 levels will be characterized. The size and number of lytic bone lesions as measured by bone survey (X-ray) or MRI will be assessed. In addition, bone mineral density (BMD) will be measured by DEXA scan and at selected sites with QCT scans.
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Estimated Enrollment: 267
Study Start Date: December 2008 Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
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