Trial Condition(s):
Neoplasms
Phase 1b multi-indication study of anetumab ravtansine in mesothelin expressing advanced solid tumors (ARCS-Multi)
Bayer Identifier:
15834
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors.
The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas.
Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule).
Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumor's objective response rate. 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 will also be collected for mesothelin expression testing and biomarker analyses.
Inclusion Criteria
- Availability of tumor tissue for mesothelin expression testing and for further biomarker analysis - Histologically-confirmed, mesothelin-expressing metastatic or advanced non-metastatic disease (tumour type specific inclusion criteria) - At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (or for thymic carcinoma, at least one measurable lesion per International Thymic Malignancy Interest Group (ITMIG) modified RECIST 1.1 criteria - Adequate bone marrow, liver, renal and coagulation function - Left ventricular ejection fraction (LVEF) ≥ 50% of the lower limit of normal (LLN) according to local institutional ranges - Eastern Cooperative Oncology Group (ECOG) 0 or 1
Exclusion Criteria
- Exposure to more than one prior anti-tubulin/microtubule agent - Corneal epitheliopathy or any eye disorder that may predispose the patients to this condition - Symptomatic Central nervous system (CNS) metastases and/or carcinomatous meningitis - Contraindication to both CT and MRI contrast agents - Active hepatitis B or C infection - Pregnant or breast-feeding patients - Tumor type specific exclusion criteria
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
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Locations UZ Antwerpen EDEGEM, Belgium, 2650 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CHU de Liège LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hôpital Erasme/Erasmus Ziekenhuis BRUXELLES - BRUSSEL, Belgium, 1070 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MedStar Georgetown University Hospital Washington, United States, 20007 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Cancer Institute - Maryland Bethesda, United States, 20892 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National University Hospital Singapore, Singapore, 119228 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Cancer Center Singapore Singapore, Singapore, 169610 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Texas MD Anderson Cancer Center Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centro Integral Oncológico Clara Campal Madrid, Spain, 28050 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Ramón y Cajal | Oncología Madrid, Spain, 28034 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Virgen de la Victoria Málaga, Spain, 29010 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Universitario 12 de Octubre Madrid, Spain, 28041 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Mayo Clinic Hospital Phoenix, United States, 85054-4502 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Vanderbilt University Medical Center Nashville, United States, 37232 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Blacktown Cancer & Haematology Centre Blacktown, Australia, 2148 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations St John of God Healthcare Subiaco, Australia, 6008 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sir Charles Gairdner Hospital Nedlands, Australia, 6009 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kinghorn Cancer Centre Darlinghurst, Australia, 2010 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hopital Jean Minjoz BESANCON, France, 25030 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hôpital Henri Mondor CRETEIL, France, 94010 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centre Oscar Lambret - Lille LILLE CEDEX, France, 59020 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centre Hospitalier Lyon Sud PIERRE BENITE, France, 69495 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations C.H.U. Timone Marseille, France, 13385 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centre René Gauducheau Nantes, France, 44805 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Mayo Clinic - Rochester Rochester, United States, 55905 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Epworth HealthCare Richmond, Australia, 3122 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Mid North Coast Cancer Institute Coffs Harbour, Australia, 2450 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Indiana University School of Medicine Indianapolis, United States, 46202 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Northern Cancer Institute St Leonards, Australia, 2065 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Flinders Medical Centre Adelaide, Australia, 5042 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Cross Cancer Institute Edmonton, Canada, T6G 1Z2 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Princess Margaret Cancer Centre - UHN Toronto, Canada, M5G 2M9 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sir Mortimer B. Davis Jewish General Hospital Montreal, Canada, H3T 1E2 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hôpital Pontchaillou RENNES CEDEX, France, 35033 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centre Eugène Marquis - Rennes Cedex RENNES CEDEX, France, 35062 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nederlands Kanker Instituut AMSTERDAM, Netherlands, 1066 CX | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centre Léon Bérard LYON CEDEX, France, 69008 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kantonsspital Graubünden Chur, Switzerland, 7000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ospedale Regionale Bellinzona Bellinzona, Switzerland, 6500 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Institut Gustave Roussy VILLEJUIF CEDEX, France, 94805 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Istituto Clinico Humanitas - Humanitas Mirasole S.p.A. Milano, Italy, 20089 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U. di Bologna Policlinico S.Orsola Malpighi Bologna, Italy, 40138 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations ASST Grande Ospedale Metropolitano Niguarda Milano, Italy, 20162 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U. di Modena - Policlinico Modena, Italy, 41124 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fondazione IRCCS Istituto Nazionale dei Tumori Milano, Italy, 20133 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U.I. Verona Verona, Italy, 37134 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hôpital de la Milétrie POITIERS cedex, France, 86021 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centre Antoine Lacassagne NICE CEDEX 2, France, 06102 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Barbara Ann Karmanos Cancer Institute Farmington Hills, United States, 48334 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Stanford Health Care Stanford, United States, 94305 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ochsner Medical Center - New Orleans New Orleans, United States, 70121 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Southern California Los Angeles, United States, 90033 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Severance Hospital, Yonsei University Health System Seoul, South Korea, 03722 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Washington University School of Medicine St. Louis, United States, 63110 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Asan Medical Center Seoul, South Korea, 05505 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Samsung Medical Center Seoul, South Korea, 06351 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Seoul National University Hospital Seoul, South Korea, 03080 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Guy’s Hospital London, United Kingdom, SE1 9RT | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Christie Hospital Manchester, United Kingdom, M20 4BX | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Royal Marsden NHS Trust (Surrey) Sutton, United Kingdom, SM2 5PT | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Royal Marsden Hospital (London) London, United Kingdom, SW3 6JJ | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Leicester Royal Infirmary Leicester, United Kingdom, LE1 5WW | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Belfast City Hospital Belfast, United Kingdom, BT12 7AB | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Universitario Quirón de Madrid Pozuelo de Alarcón, Spain, 28223 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital del Mar Barcelona, Spain, 08003 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital General Universitario Gregorio Marañón | Oncología Madrid, Spain, 28007 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Texas Oncology, PA Dallas, United States, 75246 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations McGill University Health Center Montreal, Canada, H4A 3J1 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Maastricht UMC MAASTRICHT, Netherlands, 6229 HX | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Phase 1b multi-indication study of anetumab ravtansine (BAY94-9343) in patients with mesothelin expressing advanced or recurrent malignancies
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Number of patients in the safety lead-in (SLI) phase who completed Cycle 1 or had a DLT and were not replaced.During SLI, patients with cholangiocarcinoma received anetumab ravtansine in combination with cisplatin and patients with pancreatic adenocarcinoma received anetumab ravtansine in combination with gemcitabine. The highest dose of anetumab ravtansine that can be given so that not more than 1 out of 6 patients experiences a dose-limiting toxicity (DLT) during the DLT evaluation period were declared as the MTD for anetumab ravtansine in combination with cisplatin or with gemcitabine.Timeframe: At least 3 weeks after the last patient starts treatment
- Objective response (qualitative improvement from baseline) of anetumab ravtansine for monotherapy and combination therapy in mesothelin expressing advanced solid tumorsA patient is a responder if the patient has a best response compared to baseline of complete response (CR) or partial response (PR) among all post-baseline tumor assessments, as determined per RECIST 1.1 criteria (ITMIG modified RECIST 1.1 criteria for thymic carcinoma)Timeframe: Up to approximately 26 months after patient starts treatment
- Durable disease control (lack of progression from baseline) of anetumab ravtansine in indications pancreatic and gastric cancer (co-primary endpoint)A patient experiences durable disease control if the patient has a tumor response compared to baseline of CR, PR or stable disease (SD) among the post-baseline tumor assessments made at least 180 days from first treatment, without prior disease progressionTimeframe: Up to approximately 26 months after patient starts treatment
Secondary Outcome
- Number of serious and non-serious adverse events (AEs)Include treatment-emergent AEs, SAEs, treatment-related AEs, AEs of special interest, and deaths.Timeframe: Approximately 26 months (Until 30 days after the last day of study treatment, or until later resolution of adverse events or determination by the investigator that the event will not improve)
- Disease control rate (DCR)The DCR is defined as the number of patients with disease control divided by the number of treated patients.Timeframe: Up to approximately 24 months after last patient starts treatment, or until earlier disease progression [assessed every 6 weeks for the first 6 months, every 9 weeks until end of year 1 and every 12 weeks thereafter]
- Duration of response (DOR)DOR is defined in responders as the time from documentation of tumor response (CR or PR) to earlier of disease progression or deathTimeframe: Up to approximately 24 months after last patient starts treatment, or until earlier disease progression [assessed every 6 weeks for the first 6 months, every 9 weeks until end of year 1 and every 12 weeks thereafter]
- Durable response rate (DRR)A durable responder is defined as a responder (CR or PR) with a duration of response per RECIST 1.1 criteria (ITMIG modified RECIST 1.1 criteria for thymic carcinoma) of 180 days or more. The DRR is the number of durable responders divided by the number of treated patients.Timeframe: Up to approximately 24 months after last patient starts treatment, or until earlier disease progression [assessed every 6 weeks for the first 6 months, every 9 weeks until end of year 1 and every 12 weeks thereafter]
- Progression free survival (PFS)PFS is defined as time from start of treatment until disease progression according to RECIST 1.1 (ITMIG modified RECIST 1.1 criteria for thymic carcinoma) or death.Timeframe: Up to approximately 24 months after last patient starts treatment, or until earlier disease progression [assessed every 6 weeks for the first 6 months, every 9 weeks until end of year 1 and every 12 weeks thereafter]
- Durable disease control rate (DDCR) of anetumab ravtansine in indications other than pancreatic and gastric cancerA patient experiences durable disease control if the patient has a tumor response of CR, PR or SD with CR, PR or SD assessed at least 180 days from first treatment, without prior progression.Timeframe: Up to approximately 24 months after last patient starts treatment, or until earlier disease progression [assessed every 6 weeks for the first 6 months, every 9 weeks until end of year 1 and every 12 weeks thereafter]
Additional Information
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