A Trial of MBC-11 in Patients With CIBD

NCT02673060 | Completed Phase 1 DMC

• 1 other identifier: OB-MBC-01
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bone Metastasis

Outcome Measures

Primary Outcomes (3)

• Incidence of Treatment-Emergent Adverse Events

  evaluation of adverse events, physical examination, laboratory parameters

  up to 20 weeks

• Dose Limiting Toxicity [DLT]

  dose limiting toxicity is graded according to NCI CN CFT version 4

  up to 20 weeks

• Maximum tolerated dose

  up to 20 weeks

Secondary Outcomes (7)

• Maximum Plasma Concentration [Cmax] of MBC-11

  5 weeks

• Pharmacodynamic parameters

  up to 20 weeks

• Fluorodeoxyglucose positron emission tomography-computed tomography [FDG PET-CT] response after cycle 2 and cycle 4 therapy

  up to 20 weeks

• Maximum Plasma Concentration [Cmax] of etidronate

  5 weeks

• Maximum Plasma Concentration [Cmax] of ara-U

  5 weeks

Study Arms (1)

dose escalation of MBC-11

EXPERIMENTAL

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

Interventions

MBC-11 DRUG

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.

dose escalation of MBC-11

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[measured or calculated by nomogram\]).

You may not qualify if:

• Systemic chemotherapy and/or investigational therapy within the previous 4 weeks
• Brain metastasis
• Serum calcium levels \< 8.5 mg/dL (\< 2.2 mmol/L)

Sponsors & Collaborators

• Osteros Biomedica Ltd: lead

Related Publications (1)

• Zinnen SP, Karpeisky A, Von Hoff DD, Plekhova L, Alexandrov A. First-in-Human Phase I Study of MBC-11, a Novel Bone-Targeted Cytarabine-Etidronate Conjugate in Patients with Cancer-Induced Bone Disease. Oncologist. 2019 Mar;24(3):303-e102. doi: 10.1634/theoncologist.2018-0707. Epub 2018 Nov 9.

  PMID: 30413669 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: February 3, 2016
• Study Start: July 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 29, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share