- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02673060
A Trial of MBC-11 in Patients With CIBD
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 Overview
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)
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-Emergent Adverse Events
Time Frame: up to 20 weeks
|
evaluation of adverse events, physical examination, laboratory parameters
|
up to 20 weeks
|
Dose Limiting Toxicity [DLT]
Time Frame: up to 20 weeks
|
dose limiting toxicity is graded according to NCI CN CFT version 4
|
up to 20 weeks
|
Maximum tolerated dose
Time Frame: up to 20 weeks
|
up to 20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Plasma Concentration [Cmax] of MBC-11
Time Frame: 5 weeks
|
Cmax will be evaluated during Cycle 1
|
5 weeks
|
Pharmacodynamic parameters
Time Frame: up to 20 weeks
|
Levels of bone turnover markers is measured
|
up to 20 weeks
|
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
|
up to 20 weeks
|
Maximum Plasma Concentration [Cmax] of etidronate
Time Frame: 5 weeks
|
pharmacokinetics [PK] assessment of MBC-11 metabolite
|
5 weeks
|
Maximum Plasma Concentration [Cmax] of ara-U
Time Frame: 5 weeks
|
PK assessment of MBC-11 metabolite
|
5 weeks
|
Peak time [Tmax] for MBC-11
Time Frame: 5 weeks
|
PK parameters assessment of study drug
|
5 weeks
|
Peak time [Tmax] for etidronate
Time Frame: 5 weeks
|
PK assessment of MBC-11metabolite
|
5 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OB-MBC-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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