A Trial of MBC-11 in Patients With CIBD

Bone Metastasis Clinical Trial

Official title:

A Phase 1 Multicenter, Open-label, Dose-escalation Trial of MBC-11, an Etidronate-ara-C Conjugate in Patients With Malignant Tumors With Cancer-induced Bone Disease (CIBD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02673060
• Other study ID #: OB-MBC-01
• Status: Completed
• Phase: Phase 1
• First received: January 22, 2016
• Last updated: March 28, 2016
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Osteros Biomedica Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian FederationRussia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

A standard "3+3" dose escalation design to determine Maximum Tolerated Dose with consecutive different dose level cohort recruitment.

The following dose levels to be investigated: 0.5 mg/kg, 1.0 mg/kg, 2.5 mg/kg, 5.0 mg/kg, 10 mg/kgm 20 mg/kg. The study for each patient consists of 14-days screening period, single dose administration of MBC-11 followed by 7-day safety monitoring and then 2 cycles of multiple use of MBC-11 (28 days each cycle, study drug is administered at Days1-5). In case of partial metabolic reaction/stable metabolic reaction therapy maybe prolonged up to 4 cycles (at investigator and sponsor consideration)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Metastasis

Intervention

Drug:
• MBC-11
0.5 mg/kg-10 mg/kg , IV (in the vein) on day 1-5 of each 28 day cycle. Number of cycles: 2, in case of partial metabolic reaction or stable metabolic reaction - up to 4.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Osteros Biomedica Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events	evaluation of adverse events, physical examination, laboratory parameters	up to 20 weeks	Yes
Primary	Dose Limiting Toxicity [DLT]	dose limiting toxicity is graded according to NCI CN CFT version 4	up to 20 weeks	Yes
Primary	Maximum tolerated dose		up to 20 weeks	Yes
Secondary	Maximum Plasma Concentration [Cmax] of MBC-11	Cmax will be evaluated during Cycle 1	5 weeks	Yes
Secondary	Pharmacodynamic parameters	Levels of bone turnover markers is measured	up to 20 weeks	No
Secondary	Fluorodeoxyglucose positron emission tomography-computed tomography [FDG PET-CT] response after cycle 2 and cycle 4 therapy	Response rate according to Positrone Emission Tomography Response Criteria in Solid Tumors [PERCIST] criteria using FDG PET/CT	up to 20 weeks	No
Secondary	Maximum Plasma Concentration [Cmax] of etidronate	pharmacokinetics [PK] assessment of MBC-11 metabolite	5 weeks	Yes
Secondary	Maximum Plasma Concentration [Cmax] of ara-U	PK assessment of MBC-11 metabolite	5 weeks	Yes
Secondary	Peak time [Tmax] for MBC-11	PK parameters assessment of study drug	5 weeks	No
Secondary	Peak time [Tmax] for etidronate	PK assessment of MBC-11metabolite	5 weeks	No