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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 events

Serum 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

Page last updated: August 20, 2015

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