Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM)

Part of paid clinical trials in La Jolla, California.

Sponsor
Bayer
Study ID
NCT02610140
Phase
PHASE2
Status
Completed

Conditions

  • Mesothelioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anetumab ravtansine (BAY94-9343) — DRUG
    Starting dose: 6.5 mg/kg administered as IV infusion over 1 h every 3 weeks until disease progression or treatment withdrawal for any reason. Dose reductions are permitted.
  • Vinorelbine — DRUG
    Starting dose: 30mg/m\^2 administered as an IV infusion over 6 to 10 min every week until disease progression or treatment withdrawal for any reason. Dose reductions are permitted per standard practise.

Study Details

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 Dates

Start date
Dec 3, 2015
Status verified
Oct 2020
Primary completion
May 31, 2017
Completion
Sep 6, 2019

Study Design

Enrollment
248 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BAY94-9343
    Drug Anetumab ravtansine given Intravenously (IV)
  • Active Comparator: Vinorelbine
    Drug Vinorelbine given Intravenously

Primary Outcome Measure

Progression-free Survival (PFS), [95% CI] [ Time Frame: From randomization till approximately 117 PFS events observed, up to approx. 30 months (data cut-off: 31-May-2017) ]

Locations (15)

FacilityCityStateZIPSite coordinators
-La JollaCalifornia92093-1503-
-AuroraColorado80045-
-NorwichConnecticut06360-
-TampaFlorida33612-
-ChicagoIllinois60612-
-ChicagoIllinois60637-
-New OrleansLouisiana70121-
-BethesdaMaryland20814-
-RochesterMinnesota55905-
-BuffaloNew York14263-0001-
-New YorkNew York10016-
-DurhamNorth Carolina27710-
-ClevelandOhio44195-
-DallasTexas75251-
-HoustonTexas77030-

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