Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)
Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Advanced Triple Negative Breast Cancer (TNBC) With High TAMs
Intervention: MCS110 (Drug); carboplatin (Drug); gemcitabine (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s): Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Overall contact: Novartis Pharmaceuticals, Phone: 1-888-669-6682
Summary
To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and
gemcitabine (carbo/gem) in advanced TNBC patients
Clinical Details
Official title: A Randomized Phase II Study of MCS110 Combined With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Progression free survival (PFS) as per RECIST v1.1 (by local investigator assessment)
Secondary outcome: Number of participants with adverse events and serioaus adverse eventsSerum concentration of free MCS110 and derived Pharmacokinetics (PK) parameters Serum concentration of free MCS110 and derived Pharmacokinetics (PK) parameters Plasma concentration of carboplatin, gemcitabine and 2',2'-difluoro-deoxyuridine (dFdU) Total Colony stimulation factor -1 (CSF-I) circulating levels, serum C-terminal telopeptide of type I collagen (CTX-I) and circulating monocytes Tumor associated macrophage (TAM) and Tumor infiltrating lymphocyte (TIL) content in pre- and post-dose tumor biopsies Tumor response per RECIST v1.1 (by local investigator assessment)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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-) Breast Cancer 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)
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 study dose.
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic
arrhythmias, congestive heart failure, or myocardial infarction within 6 months of
screening.
- 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 predose:
- 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
Locations and Contacts
Novartis Pharmaceuticals, Phone: 1-888-669-6682
Novartis Investigative Site, Salzburg 5020, Austria; Recruiting
Novartis Investigative Site, Vienna 1090, Austria; Recruiting
Novartis Investigative Site, Vienna A-1090, Austria; Not yet recruiting
Novartis Investigative Site, Brussel 1200, Belgium; Not yet recruiting
Novartis Investigative Site, Edegem 2650, Belgium; Not yet recruiting
Novartis Investigative Site, Brno 656 53, Czech Republic; Not yet recruiting
Novartis Investigative Site, Lyon Cedex 69373, France; Not yet recruiting
Novartis Investigative Site, Paris 75231, France; Not yet recruiting
Novartis Investigative Site, Paris 75970, France; Not yet recruiting
Novartis Investigative Site, Saint-Herblain Cédex 44805, France; Not yet recruiting
Novartis Investigative Site, Dresden 01307, Germany; Not yet recruiting
Novartis Investigative Site, Essen 45147, Germany; Not yet recruiting
Novartis Investigative Site, Kiel 24105, Germany; Not yet recruiting
Novartis Investigative Site, Hong Kong SAR, Hong Kong; Not yet recruiting
Novartis Investigative Site, Madrid 28050, Spain; Not yet recruiting
Novartis Investigative Site, Taipei 10002, Taiwan; Not yet recruiting
Novartis Investigative Site, Istanbul 35100, Turkey; Not yet recruiting
Novartis Investigative Site, Sihhiye/Ankara 06100, Turkey; Not yet recruiting
Highlands Oncology Group, Fayetteville, Arkansas 72703, United States; Not yet recruiting Holly Kinser, Phone: 479-587-1700, Email: hkinser@hogonc.com J. Thaddeus Beck, Principal Investigator
Novartis Investigative Site, Barcelona, Catalunya 08035, Spain; Not yet recruiting
Novartis Investigative Site, Valencia, Comunidad Valenciana 46009, Spain; Not yet recruiting
Yale University School of Medicine SC-3, New Haven, Connecticut 06520, United States; Not yet recruiting Brittany Walker, Phone: 203-737-2226, Email: Brittany.walker@yale.edu Maysa Abu-Khalaf, Principal Investigator
Novartis Investigative Site, Santiago de Compostela, Galicia 15706, Spain; Not yet recruiting
Novartis Investigative Site, Seoul, Korea 110 744, Korea, Republic of; Not yet recruiting
Novartis Investigative Site, Seoul, Korea 138-736, Korea, Republic of; Not yet recruiting
Massachusetts General Hospital Cancer Center SC, Boston, Massachusetts 02114, United States; Not yet recruiting Rachel Hepp, Phone: 617-724-0878, Email: rhepp@mgh.harvard.edu Aditya Bardia, Principal Investigator
Novartis Investigative Site, Clayton, Victoria 3168, Australia; Not yet recruiting
Novartis Investigative Site, Perth, Western Australia 6005, Australia; Not yet recruiting
Additional Information
Starting date: July 2015
Last updated: August 9, 2015
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