Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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2 June 2020 |
Main ID: |
EUCTR2015-000179-29-FR |
Date of registration:
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20/07/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A study evaluating if the addition of MCS110 increases the efficacy of chemotherapy in women with disseminated breast cancer that is not dependent on hormones
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Scientific title:
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A randomized phase II study of MCS110 combined with carboplatin and gemcitabine in advanced Triple Negative Breast Cancer (TNBC) |
Date of first enrolment:
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03/08/2015 |
Target sample size:
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78 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000179-29 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Other specify the comparator: carboplatin , gemcitabine Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Austria
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Belgium
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Czech Republic
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France
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Germany
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Hong Kong
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Israel
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Korea, Democratic People's Republic of
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Spain
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Taiwan
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Turkey
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United States
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Contacts
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Name:
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Communication&Information Médicale
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Address:
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2/4 rue Lionel Terray
92500
Rueil-Malmaison
France |
Telephone:
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+33155476100 |
Email:
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icm.phfru@novartis.com |
Affiliation:
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Novartis Pharma S.A.S. |
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Name:
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Communication&Information Médicale
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Address:
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2/4 rue Lionel Terray
92500
Rueil-Malmaison
France |
Telephone:
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+33155476100 |
Email:
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icm.phfru@novartis.com |
Affiliation:
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Novartis Pharma S.A.S. |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Adult women (= 18 years of age) with advanced TNBC.
- Histological or cytological evidence of estrogen-receptor negative (ER-), progesterone receptor negative (PgR-) and human epidermal growth factor-2 receptor negative (HER2-) BC by local laboratory testing, based on last available tumor tissue.
- ER/PgR negativity to follow local guidelines
- If IHC HER2 2+, a negative FISH test is required
A pre-treatment tumor biopsy demonstrating high TAM content as assessed per the central laboratory (approximately 15% of TAMs or above).
- Patients must have:
- At least one measurable lesion per RECIST 1.1. (Note: Measurable lesions include lytic or mixed (lytic + blastic) bone lesions, with an identifiable soft tissue component that meets the measurability criteria)
or
- Bone lesions: non-measurable lytic or mixed (lytic + sclerotic) in the absence of measurable disease as defined above. Patients with only non-measurable lesions (e.g. pleural effusion, ascites) and no lytic or mixed bone lesions are not eligible.
Other inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 23
Exclusion criteria: - Prior chemotherapy for advanced BC. Previous adjuvant/neoadjuvant chemotherapy is allowed.
- Therapy for underlying malignancy within 2 weeks prior to start of study treatment:
- Chemotherapy, biologic therapy (antibodies and biologically targeted small molecules)
- Radiotherapy
- Major surgery
- Patients receiving concomitant immunosuppressive agents or chronic corticosteroids (= 10 mg of prednisone or equivalent) at the time of first dose of study drug.
- Known history of human immunodeficiency virus or active infection with hepatitis virus or any uncontrolled active systemic infection.
- Patients with the following laboratory values during screening and on Day 1 pre-dose:
- Absolute Neutrophil Count (ANC) < 1.0x109/L
- Hemoglobin < 9 g/dL
- Platelets < 100x109/L
- Serum creatinine > 1.5 x ULN
- Serum total bilirubin > 1.5 x ULN
- AST/SGOT and ALT/SGPT > 3.0 x ULN
Other exclusion criteria may apply
Age minimum:
Age maximum:
Gender:
Female: yes Male: no
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Health Condition(s) or Problem(s) studied
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Advanced Triple Negative Breast Cancer MedDRA version: 18.0
Level: LLT
Classification code 10072737
Term: Advanced breast cancer
System Organ Class: 100000004864
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Product Name: MCS110 Product Code: MCS110 Pharmaceutical Form: Concentrate for solution for infusion Current Sponsor code: MCS110 Other descriptive name: MCS110 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20/1-
Trade Name: carboplatin Product Name: carboplatin Pharmaceutical Form: Solution for infusion Other descriptive name: Carboplatin Actavis Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10-
Trade Name: Gemcitabine Sandoz Product Name: Gemcitabine Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: GEMCITABINE CAS Number: 95058-81-4 Other descriptive name: Gemcitabine sandoz Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40-
Trade Name: Gemcitabine Sandoz Product Name: Gemcitabine Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: GEMCITABINE CAS Number: 95058-81-4 Other descriptive name: Gemcitabine sandoz Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40-
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: Tumor evaluation at sreening and then every six weeeks until the end of cycle 8. Thereafter every 9 weeks (after cycle 8).
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Main Objective: To assess the anti-tumor activity of MCS110 combined with carboplatin/gemcitabine (carbo/gem) compared to carbo/gem alone.
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Primary end point(s): PFS as per RECIST v1.1 (by local investigator assessment)
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Secondary Objective: 1. Characterize the safety and tolerability of MCS110 given in combination with carbo/gem. 2. Characterize PK of MCS110 when combined with carbo/gem. 3. Characterize PK of carbo and gem in the presence and absence of MCS110. 4. Characterize PD effect of MCS110 when combined with carbo/gem 5. To assess the anti-tumor activity of MCS110 given in combination with carbo/gem as measured by additional efficacy measures.
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Secondary Outcome(s)
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Secondary end point(s): 1. Safety: adverse event (AEs), serious adverse events (SAEs) Tolerability: Dose interruptions, reductions and dose intensity
2. Serum concentration of free MCS110 and derived PK parameters
3. Plasma concentration of carboplatin, gemcitabine and dFdU (the primary metabolite of gem), and derived PK parameters
4. Total CSF-I circulating levels, serum CTX-I and circulating monocytes in blood. TAM and TIL content in pre- and post-dose tumor biopsies
5. Tumor response per RECIST v1.1 (by local investigator assessment):
Overall Response Rate (ORR), Duration of Response (DOR), Clinical Benefit Rate (Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) = 6 months) and Overall Survival (OS).
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Timepoint(s) of evaluation of this end point: 1. Continuously
2. Please refer to protocol section 7
3. Please refer to protocol section 7
4. Please refer to protocol section 7
5. ORR:Tumor evaluation at screening and then every six weeks until the end of cycle 8. Thereafter every 9 weeks (after cycle 8).
DOR: Tumor evaluation at screening and then every six weeks until the end of cycle 8. Thereafter every 9 weeks (after cycle 8).
Clinical benefit rate: Tumor evaluation at screening and then every six weeks until the end of cycle 8. Thereafter every 9 weeks (after cycle 8).
Overall survival: 4, 6, 9, 12 and 18 months
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Secondary ID(s)
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2015-000179-29-CZ
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CMCS110Z2201
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Source(s) of Monetary Support
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Novartis Pharma Services AG
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Ethics review
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Status: Approved
Approval date: 24/07/2015
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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