Bone MetastasisPhase 1NCT02673060
A Trial of MBC-11 in Patients With CIBD
A Phase 1 study testing MBC-11 in people with Bone Metastasis, run by Osteros Biomedica Ltd.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastasis
- What is being tested?
- MBC-11
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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]).
Who cannot join
- 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)
About this study
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)
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.
Read the 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)
- Conditions
- Bone Metastasis
- Being tested
- MBC-11
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBC-11Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: MBC-11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
evaluation of adverse events, physical examination, laboratory parameters
Measured: up to 20 weeks
Dose Limiting Toxicity [DLT]
dose limiting toxicity is graded according to NCI CN CFT version 4
Measured: up to 20 weeks
Maximum tolerated dose
Measured: up to 20 weeks
Secondary outcomes (7)
Maximum Plasma Concentration [Cmax] of MBC-11
Cmax will be evaluated during Cycle 1
Measured: 5 weeks
Pharmacodynamic parameters
Levels of bone turnover markers is measured
Measured: up to 20 weeks
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
Measured: up to 20 weeks
Maximum Plasma Concentration [Cmax] of etidronate
pharmacokinetics [PK] assessment of MBC-11 metabolite
Measured: 5 weeks
Maximum Plasma Concentration [Cmax] of ara-U
PK assessment of MBC-11 metabolite
Measured: 5 weeks
Peak time [Tmax] for MBC-11
PK parameters assessment of study drug
Measured: 5 weeks
Peak time [Tmax] for etidronate
PK assessment of MBC-11metabolite
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startJul 2014
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osteros Biomedica Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673060
- Sponsor's protocol ID
- OB-MBC-01
- Status last verified
- Mar 2016
- First submitted
- 22 Jan 2016
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30413669
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02673060
- Acronym / sponsor ID
- OB-MBC-01
- Conditions
- Bone Metastasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Osteros Biomedica LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dose escalation of MBC-11 | Experimental | Drug: MBC-11MBC-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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBC-110.5 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. | Drug | dose escalation of MBC-11 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: up to 20 weeks
evaluation of adverse events, physical examination, laboratory parameters
Dose Limiting Toxicity [DLT]
Time frame: up to 20 weeks
dose limiting toxicity is graded according to NCI CN CFT version 4
Maximum tolerated dose
Time frame: up to 20 weeks
7 secondary outcomes
Maximum Plasma Concentration [Cmax] of MBC-11
Time frame: 5 weeks
Pharmacodynamic parameters
Time frame: 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
Maximum Plasma Concentration [Cmax] of etidronate
Time frame: 5 weeks
Maximum Plasma Concentration [Cmax] of ara-U
Time frame: 5 weeks
Peak time [Tmax] for MBC-11
Time frame: 5 weeks
Peak time [Tmax] for etidronate
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
- Derived from this study: PubMed 30413669Zinnen 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.
- Individual participant dataSharing planned: No
Related trials for Bone Metastasis
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Active, not recruitingPhase 3
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Melanoma, Ovarian Cancer
RecruitingPhase 2
Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma
Osteogenic Sarcoma Recurrent
RecruitingObservational study
Change in Fat Fraction Quantification Before and After Treatment in Bone Metastases
Neoplasm Metastasis / Bone and Bones
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MBC-11 in people with Bone Metastasis, run by Osteros Biomedica Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: up to 20 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02673060, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2016.