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Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC) (TNBC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02435680
Recruitment Status : Active, not recruiting
First Posted : May 6, 2015
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and gemcitabine (carbo/gem) in advanced TNBC patients

Condition or disease Intervention/treatment Phase
Advanced Triple Negative Breast Cancer (TNBC) With High TAMs Drug: MCS110 Drug: carboplatin Drug: gemcitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of MCS110 Combined With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)
Actual Study Start Date : August 10, 2015
Estimated Primary Completion Date : September 19, 2019
Estimated Study Completion Date : September 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Arm 1: MCS110+carboplatin+gemcitabine
MCS110+carboplatin+gemcitabine
Drug: MCS110
taken by I.V

Drug: carboplatin
taken by I.V

Drug: gemcitabine
taken by I.V

Active Comparator: Arm 2: carboplatin+gemcitabine
carboplatin+gemcitabine
Drug: carboplatin
taken by I.V

Drug: gemcitabine
taken by I.V




Primary Outcome Measures :
  1. Progression free survival (PFS) as per RECIST v1.1 (by local investigator assessment) [ Time Frame: 7 months ]

Secondary Outcome Measures :
  1. Number of participants with adverse events and serioaus adverse events [ Time Frame: 7 months ]
  2. Serum concentration of free MCS110 and derived Pharmacokinetics (PK) parameters: AUC [ Time Frame: 7 months ]
  3. Serum concentration of free MCS110 and derived Pharmacokinetics (PK) parameters: Cmax [ Time Frame: 7 months ]
  4. Plasma concentration of carboplatin, gemcitabine and 2',2'-difluoro-deoxyuridine (dFdU) [ Time Frame: 7 months ]
  5. Total Colony stimulation factor -1 (CSF-I) circulating levels, serum C-terminal telopeptide of type I collagen (CTX-I) and circulating monocytes [ Time Frame: 7 months ]
  6. Tumor associated macrophage (TAM) and Tumor infiltrating lymphocyte (TIL) content in pre- and post-dose tumor biopsies [ Time Frame: 7 months ]
  7. Tumor response per RECIST v1.1 (by local investigator assessment) [ Time Frame: 7 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • 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 (carboplatin, cisplatin or gemcitabine only if > 12 months has passed since last administration).
  • 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) < 1.5x109/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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435680


  Show 29 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02435680     History of Changes
Other Study ID Numbers: CMCS110Z2201
2015-000179-29 ( EudraCT Number )
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
MCS110; carboplatin; gemcitabine; TNBC; TAMs

Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs