A Trial of MBC-11 in Patients With CIBD

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates MBC-11 (a conjugate of a bone-targeting vehicle (etidronate) and a cytostatic agent [ara-C] in patients with malignant tumors with CIBD. This is a first use in human.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Osteros Biomedica Ltd

Criteria

Inclusion Criteria:

• Histologically confirmed malignant tumor (breast cancer, prostate cancer etc)

• Bone metastases, documented by radiographs, bone scan

• No available standard chemotherapy or no indication for chemotherapy at the time of screening

• Eastern Cooperative Oncology Group [ECOG] status 0-2

• Adequate bone marrow function (hemoglobin ≥ 9 g/dL with or without transfusion requirement, absolute neutrophil count ≥ 1500/mm3, and platelets ≥ 75,000/mm3)

• Adequate liver function (bilirubin ≤ 2 x Upper Limit of Normal [ULN], Alanine aminotransferase [ALT] ≤ 2.5 x ULN).

• Adequate renal function (creatinine ≤ 1.5 x ULN) and creatinine clearance ≥ 50 mL/min [measured or calculated by nomogram]).

Exclusion Criteria:

• Systemic chemotherapy and/or investigational therapy within the previous 4 weeks

• Fracture ≤ 6 month prior the inclusion in the study

• Brain metastasis

• Serum calcium levels < 8.5 mg/dL (< 2.2 mmol/L)