check_circleStudy Completed

Mesothelioma

Bayer Identifier:

15743

ClinicalTrials.gov Identifier:

NCT02610140

EudraCT Number:

2012-003650-88

EU CT Number:

Not Available
Phase II anetumab ravtansine as 2nd line treatment for malignant pleural mesothelioma (MPM)

Trial purpose

The main purpose of the 15743 study is to assess efficacy and safety of anetumab ravtansine versus vinorelbine in progression free survival in patients with stage IV mesothelin overexpressing malignant pleural mesothelioma (MPM).
210 eligible patients will be randomized to receive either anetumab ravtansine every three weeks or weekly vinorelbine.
Treatment will continue until centrally confirmed disease progression or until another criterion is met for withdrawal from the study. Patients will enter follow up phase to capture safety and endpoint data as required.
Efficacy will be measured by evaluating progression free survival from randomization. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses.
Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue may also be collected for central pathology review and biomarkers.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Histological documentation of malignant pleural mesothelioma (MPM) overexpressing mesothelin
    - Unresectable locally advanced or metastatic MPM after locally confirmed progression on 1st line treatment with platinum in combination with pemetrexed.
    - Patients must have measurable disease
    - Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
    - Life expectancy of at least 3 months.
    - Adequate bone marrow, liver and renal function
    - Left ventricular ejection fraction (LVEF) ≥ 50% or the lower limit of normal (LLN) according to local institution ranges of normality.
  • - More than 1 previous systemic anti-cancer therapy line
    - Patients with corneal epitheliopathy or any eye disorder that may predispose the patients to this condition at the discretion of the investigator in consultation with the
    ophthalmologist.
    - Brain metastases, meningeal tumours or other metastases in the central nervous system
    - Evidence of history of bleeding diathesis.
    - Ongoing or active infection (bacterial, fungal, or viral) of National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade > 2.
    - Pre-existing cardiac conditions

Trial summary

Enrollment Goal
248
Trial Dates
December 2015 - September 2019
Phase
Phase 2
Could I Receive a placebo
No
Products
Anetumab ravtansine (BAY94-9343)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
EDEGEM, 2650, Belgium
Completed
Torino, 10043, Italy
Withdrawn
Heidelberg, 69126, Germany
Withdrawn
Grosshansdorf, 22927, Germany
Completed
Bergamo, 24125, Italy
Completed
Monza Brianza, 20900, Italy
Completed
Pordenone, 33081, Italy
Completed
Siena, 53100, Italy
Completed
Milano, 20089, Italy
Withdrawn
Essen, 45122, Germany
Withdrawn
Bochum, 44791, Germany
Withdrawn
Berlin, 13125, Germany
Completed
Toronto, M5G 2M9, Canada
Completed
Bethesda, 20814, United States
Completed
Dallas, 75251, United States
Completed
New Orleans, 70121, United States
Completed
Aurora, 80045, United States
Completed
Chicago, 60637, United States
Completed
Nedlands, 6009, Australia
Completed
Woolloogabba, 4102, Australia
Withdrawn
Ann Arbor, 48106, United States
Completed
London, SE1 9RT, United Kingdom
Completed
Adelaide, 5043, Australia
Completed
Barcelona, 08035, Spain
Completed
Madrid, 28041, Spain
Withdrawn
Badalona (Barcelona), 08916, Spain
Completed
A Coruña, 15006, Spain
Completed
Richmond, 3122, Australia
Withdrawn
Heidelberg, 3084, Australia
Completed
Calgary, T2N 4N2, Canada
Completed
Hamilton, L8V 5C2, Canada
Completed
Seoul, 06351, Korea, Republic Of
Completed
Seoul, 05505, Korea, Republic Of
Completed
Leicester, LE1 5WW, United Kingdom
Completed
Plymouth, PL6 8DH, United Kingdom
Completed
Newcastle Upon Tyne, NE7 7DN, United Kingdom
Completed
Manchester, M23 9LT, United Kingdom
Completed
Gdansk, 80-952, Poland
Completed
Szczecin, 70-891, Poland
Completed
Alicante, 03010, Spain
Completed
ROTTERDAM, 3015 CE, Netherlands
Completed
AMSTERDAM, 1066 CX, Netherlands
Completed
St Leonards, 2065, Australia
Completed
Ankara, 06100, Turkey
Completed
Vaasa, 65130, Finland
Completed
Helsinki, 00290, Finland
Completed
Turku, 20520, Finland
Withdrawn
San Francisco, 94115, United States
Completed
Malatya, 44280, Turkey
Completed
Istanbul, 34899, Turkey
Completed
Adana, 01330, Turkey
Completed
Yenimahalle, 06200, Turkey
Completed
Tampa, 33612, United States
Completed
Norwich, 06360, United States
Completed
La Jolla, 92093-1503, United States
Completed
Lille Cedex, 59037, France
Completed
PIERRE BENITE, 69495, France
Withdrawn
TOULOUSE CEDEX 9, 31059, France
Terminated
BORDEAUX CEDEX, 33076, France
Withdrawn
VILLEJUIF CEDEX, 94805, France
Withdrawn
TOURS, 37044, France
Completed
PARIS, 75020, France
Completed
Krakow, 31-202, Poland
Completed
Krakow, 31-501, Poland
Completed
Cleveland, 44195, United States
Completed
LEUVEN, 3000, Belgium
Completed
BRUXELLES - BRUSSEL, 1200, Belgium
Completed
GENT, 9000, Belgium
Completed
LIEGE, 4000, Belgium
Completed
Chicago, 60612, United States
Completed
Buffalo, 14263-0001, United States
Terminated
New York, 10016, United States
Completed
Houston, 77030, United States
Completed
Rochester, 55905, United States
Completed
Houston, 77030, United States
Completed
Yekaterinburg, 620036, Russian Federation
Completed
Omsk, 644013, Russian Federation
Withdrawn
Philadelphia, 19104, United States
Completed
London, N6A 4L6, Canada
Completed
Durham, 27710, United States
Completed
MARSEILLE, 13915, France
Withdrawn
Madrid, 28034, Spain
Withdrawn
Valencia, 46014, Spain
Completed
Málaga, 29010, Spain
Withdrawn
Tampere, 33521, Finland
Withdrawn
Helsinki, 00180, Finland
Completed
Milano, 20133, Italy
Withdrawn
Padova, 35128, Italy
Withdrawn
Lecce, 73100, Italy
Withdrawn
Mechelen, 2800, Belgium
Completed
SINT-NIKLAAS, 9100, Belgium
Withdrawn
Baltimore, 21201, United States
Completed
Maidstone, ME16 9QQ, United Kingdom
Completed
Glasgow, G12 0YN, United Kingdom
Withdrawn
Istanbul, 34098, Turkey
Completed
Eskisehir, 26480, Turkey
Withdrawn
Minneapolis, 55455, United States
Completed
CAEN CEDEX 5, 14076, France
Terminated
PARIS, 75018, France

Primary Outcome

  • Progression Free Survival
    Defined as time from randomization until disease progression or death. Patients not experiencing death or progression will be censored at the last tumor assessment.
    date_rangeTime Frame:
    Approx. 22 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Overall survival (OS)
    Defined as time from randomization until death from any cause. Patients lost to follow-up or alive at the time of analysis will be censored at the last known alive date.
    date_rangeTime Frame:
    Approx. 42 months
    enhanced_encryption
    Safety Issue:
    No
  • Improvement of symptoms characteristic of mesothelioma
    Improvement occurs if best change from baseline in total subset score per the MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma (MDASI-MPM) meets improvement criteria. Improvement must be confirmed by a second MDASI-MPM assessment.
    date_rangeTime Frame:
    Approx. 22 months
  • Improvement of pain
    Improvement occurs if best change from baseline in pain score per the MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma (MDASI-MPM) meets improvement criteria. Improvement must be confirmed by a second MDASI-MPM assessment.
    date_rangeTime Frame:
    Approx. 22 months
  • Objective response
    A patient is a responder if the patient’s best confirmed tumor response on-study of (complete response) CR or PR, as determined by the central radiological reviewer per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria for MPM.
    date_rangeTime Frame:
    Approx. 22 months
  • Duration of response (DOR)
    Defined in responders as time from first documentation of tumor response (CR or PR) per mRECIST criteria to disease progression or death, as determined by central radiological reviewer.
    date_rangeTime Frame:
    Approx. 42 months
  • Treatment emergent adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Approx. 22 months
  • Serious adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Approx. 22 months
  • Disease control
    A patient experiences disease control if the patient’s best response on-study confirmed tumor response of CR or PR or a tumor response of SD, as determined by the central radiological reviewer per mRECIST criteria
    date_rangeTime Frame:
    Approx. 22 months
  • Durable Response
    A patient experiences durable response if the patient is Defined in responders as a responder with a duration of response of 180 days or more as determined by the central radiological reviewer.
    date_rangeTime Frame:
    Approx. 42 months

Trial design

A randomized, open-label, active-controlled, Phase II study of intravenous anetumab ravtansine (BAY 94-9343) or vinorelbine in patients with advanced or metastatic malignant pleural mesothelioma overexpressing mesothelin and progressed on first line platinum/pemetrexed-based chemotherapy
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

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