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A Trial of MBC-11 in Patients With CIBD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673060
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : March 29, 2016
Sponsor:
Information provided by (Responsible Party):
Osteros Biomedica Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Bone Metastasis Drug: MBC-11 Phase 1

Detailed 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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : July 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: dose escalation of MBC-11
MBC-11 was administered in 5 consecutively recruited cohort in dose 0.5 mg/kg, 1 mg/kg, 2.5 mg/kg, 5 mg/kg,10 mg/kg accordingly. The dose escalation is aimed at determining the maximum tolerated dose (MTD)
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.




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: up to 20 weeks ]
    evaluation of adverse events, physical examination, laboratory parameters

  2. Dose Limiting Toxicity [DLT] [ Time Frame: up to 20 weeks ]
    dose limiting toxicity is graded according to NCI CN CFT version 4

  3. Maximum tolerated dose [ Time Frame: up to 20 weeks ]

Secondary Outcome Measures :
  1. Maximum Plasma Concentration [Cmax] of MBC-11 [ Time Frame: 5 weeks ]
    Cmax will be evaluated during Cycle 1

  2. Pharmacodynamic parameters [ Time Frame: up to 20 weeks ]
    Levels of bone turnover markers is measured

  3. Fluorodeoxyglucose positron emission tomography-computed tomography [FDG PET-CT] response after cycle 2 and cycle 4 therapy [ Time Frame: up to 20 weeks ]
    Response rate according to Positrone Emission Tomography Response Criteria in Solid Tumors [PERCIST] criteria using FDG PET/CT

  4. Maximum Plasma Concentration [Cmax] of etidronate [ Time Frame: 5 weeks ]
    pharmacokinetics [PK] assessment of MBC-11 metabolite

  5. Maximum Plasma Concentration [Cmax] of ara-U [ Time Frame: 5 weeks ]
    PK assessment of MBC-11 metabolite

  6. Peak time [Tmax] for MBC-11 [ Time Frame: 5 weeks ]
    PK parameters assessment of study drug

  7. Peak time [Tmax] for etidronate [ Time Frame: 5 weeks ]
    PK assessment of MBC-11metabolite



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Osteros Biomedica Ltd
ClinicalTrials.gov Identifier: NCT02673060    
Other Study ID Numbers: OB-MBC-01
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes