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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02435680




Registration number
NCT02435680
Ethics application status
Date submitted
22/04/2015
Date registered
6/05/2015

Titles & IDs
Public title
Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)
Scientific title
A Randomized Phase II Study of MCS110 Combined With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)
Secondary ID [1] 0 0
2015-000179-29
Secondary ID [2] 0 0
CMCS110Z2201
Universal Trial Number (UTN)
Trial acronym
TNBC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Triple Negative Breast Cancer (TNBC) With High TAMs 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MCS110
Treatment: Drugs - carboplatin
Treatment: Drugs - gemcitabine

Experimental: Arm 1: MCS110+carboplatin+gemcitabine - MCS110+carboplatin+gemcitabine

Active comparator: Arm 2: carboplatin+gemcitabine - carboplatin+gemcitabine


Treatment: Drugs: MCS110
taken by I.V

Treatment: Drugs: carboplatin
taken by I.V

Treatment: Drugs: gemcitabine
taken by I.V
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) as Per RECIST v1.1 (by Local Investigator Assessment)
Timepoint [1] 0 0
4 years
Secondary outcome [1] 0 0
Free MCS110 : Derived Pharmacokinetics (PK) Parameters: AUCtau
Timepoint [1] 0 0
day 21 (end cycle 1); day 84 (end cycle 4)
Secondary outcome [2] 0 0
Free MCS110 : Derived Pharmacokinetics (PK) Parameters: Cmax
Timepoint [2] 0 0
day 21 (end cycle 1); day 84 (end cycle 4)
Secondary outcome [3] 0 0
Cmax Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)
Timepoint [3] 0 0
day 21, day 84
Secondary outcome [4] 0 0
AUClast Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)
Timepoint [4] 0 0
day 21, day 84
Secondary outcome [5] 0 0
Total Colony Stimulation Factor -1 (CSF-I) Circulating Levels
Timepoint [5] 0 0
baseline, day 1, 4, 15, 22, 43, 64, 85, 106, 127, 148
Secondary outcome [6] 0 0
Serum C-terminal Telopeptide of Type I Collagen (CTX-I)
Timepoint [6] 0 0
baseline, day 2, 4, 15, 22, 43, 64, 85, 106, 127, 148
Secondary outcome [7] 0 0
Tumor Response Per RECIST v1.1 (by Local Investigator Assessment)
Timepoint [7] 0 0
4 years
Secondary outcome [8] 0 0
Tumor Response Per RECIST v1.1 (by Local Investigator Assessment) Duration of Response
Timepoint [8] 0 0
4 years
Secondary outcome [9] 0 0
Number of Patients With at Least One MCS110 Dose Reduction, and Number of Patients With at Least One MCS110 Dose Interruption
Timepoint [9] 0 0
4 years
Secondary outcome [10] 0 0
MCS110 Dose Intensity
Timepoint [10] 0 0
4 years
Secondary outcome [11] 0 0
Tumor Associated Macrophage (TAM) and Tumor Infiltrating Lymphocyte (TIL) Content in Pre- and Post-dose Tumor Biopsies.
Timepoint [11] 0 0
Baseline, Day 29-43
Secondary outcome [12] 0 0
Circulating Monocytes Cells in Blood
Timepoint [12] 0 0
day 15, 29, 43, 50

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/03/2020
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
Austria
State/province [3] 0 0
Salzburg
Country [4] 0 0
Austria
State/province [4] 0 0
Vienna
Country [5] 0 0
Belgium
State/province [5] 0 0
Bruxelles
Country [6] 0 0
France
State/province [6] 0 0
Paris
Country [7] 0 0
France
State/province [7] 0 0
Saint-Herblain Cédex
Country [8] 0 0
Germany
State/province [8] 0 0
Berlin
Country [9] 0 0
Germany
State/province [9] 0 0
Dresden
Country [10] 0 0
Germany
State/province [10] 0 0
Essen
Country [11] 0 0
Hong Kong
State/province [11] 0 0
Hong Kong SAR
Country [12] 0 0
Italy
State/province [12] 0 0
Bologna
Country [13] 0 0
Italy
State/province [13] 0 0
Napoli
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Korea
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul
Country [16] 0 0
Spain
State/province [16] 0 0
Catalunya
Country [17] 0 0
Spain
State/province [17] 0 0
Galicia
Country [18] 0 0
Spain
State/province [18] 0 0
Barcelona
Country [19] 0 0
Spain
State/province [19] 0 0
Madrid
Country [20] 0 0
Taiwan
State/province [20] 0 0
Taipei
Country [21] 0 0
Turkey
State/province [21] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
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


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02435680