NeoplasmsPhase 1ARCS-MultiNCT03102320
Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors
A Phase 1 study testing Cisplatin, Gemcitabine and Anetumab ravtansine (BAY94-9343) in people with Neoplasms, run by Bayer at 72 sites in 12 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Cisplatin, Gemcitabine and Anetumab ravtansine (BAY94-9343)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 72 sitesin 12 countries
- Study dates
- 26 May 2017to 26 Jul 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
72 sites in 12 countries.
72 sites in 12 countries
United States13 sites
National Cancer Institute - Maryland
Bethesda, Maryland, 20892
Texas Oncology, PA
Dallas, Texas, 75246
Barbara Ann Karmanos Cancer Institute
Farmington Hills, Michigan, 48334
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Indiana University School of Medicine
Indianapolis, Indiana, 46202
University of Southern California
Los Angeles, California, 90033
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Ochsner Medical Center - New Orleans
New Orleans, Louisiana, 70121
Mayo Clinic Hospital
Phoenix, Arizona, 85054-4502
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford Health Care
Stanford, California, 94305
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
France12 sites
Hopital Jean Minjoz
Besançon, 25030
Hôpital Henri Mondor
Créteil, 94010
Centre Oscar Lambret - Lille
Lille, 59020
Centre Léon Bérard
Lyon, 69008
C.H.U. Timone
Marseille, 13385
Centre René Gauducheau
Nantes, 44805
Centre Antoine Lacassagne
Nice, 06102
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Hôpital de la Milétrie
Poitiers, 86021
Hôpital Pontchaillou
Rennes, 35033
Centre Eugène Marquis - Rennes Cedex
Rennes, 35062
Institut Gustave Roussy
Villejuif, 94805
Spain9 sites
Hospital del Mar
Barcelona, 08003
Ciutat Sanitària i Universitaria de la Vall d'Hebron
Barcelona, 08035
Hospital Clínic i Provincial de Barcelona
Barcelona, 08036
Hospital General Universitario Gregorio Marañón | Oncología
Madrid, 28007
Hospital Ramón y Cajal | Oncología
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Centro Integral Oncológico Clara Campal
Madrid, 28050
Hospital Virgen de la Victoria
Málaga, 29010
Hospital Universitario Quirón de Madrid
Pozuelo de Alarcón, Madrid, 28223
Australia8 sites
Flinders Medical Centre
Adelaide, South Australia, 5042
Blacktown Cancer & Haematology Centre
Blacktown, New South Wales, 2148
Mid North Coast Cancer Institute
Coffs Harbour, New South Wales, 2450
Kinghorn Cancer Centre
Darlinghurst, New South Wales, 2010
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Epworth HealthCare
Richmond, Victoria, 3122
Northern Cancer Institute
St Leonards, New South Wales, 2065
St John of God Healthcare
Subiaco, Western Australia, 6008
Italy6 sites
A.O.U. di Bologna Policlinico S.Orsola Malpighi
Bologna, Emilia-Romagna, 40138
Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.
Milan, Lombardy, 20089
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20133
ASST Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, 20162
A.O.U. di Modena - Policlinico
Modena, Emilia-Romagna, 41124
A.O.U.I. Verona
Verona, Veneto, 37134
United Kingdom6 sites
Belfast City Hospital
Belfast, North Ireland, BT12 7AB
Leicester Royal Infirmary
Leicester, Leicestershire, LE1 5WW
Guy's Hospital
London, SE1 9RT
Royal Marsden Hospital (London)
London, SW3 6JJ
Christie Hospital
Manchester, M20 4BX
Royal Marsden NHS Trust (Surrey)
Sutton, Surrey, SM2 5PT
Belgium4 sites
Hôpital Erasme/Erasmus Ziekenhuis
Bruxelles - Brussel, 1070
UZ Antwerpen
Edegem, 2650
UZ Leuven Gasthuisberg
Leuven, 3000
CHU de Liège
Liège, 4000
Canada4 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, H3T 1E2
McGill University Health Center
Montreal, Quebec, H4A 3J1
Princess Margaret Cancer Centre - UHN
Toronto, Ontario, M5G 2M9
South Korea4 sites
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Netherlands2 sites
Nederlands Kanker Instituut
Amsterdam, 1066 CX
Maastricht UMC
Maastricht, 6229 HX
Singapore2 sites
National University Hospital
Singapore, 119228
National Cancer Center Singapore
Singapore, 169610
Switzerland2 sites
Ospedale Regionale Bellinzona
Bellinzona, Canton Ticino, 6500
Kantonsspital Graubünden
Chur, Kanton Graubünden, 7000
About this study
Official title: Phase 1b Multi-indication Study of Anetumab Ravtansine (BAY94-9343) in Patients With Mesothelin Expressing Advanced or Recurrent Malignancies
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.
Read more
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.
- Conditions
- Neoplasms
- Being tested
- Cisplatin, Gemcitabine, Anetumab ravtansine (BAY94-9343)
- Keywords
- cholangiocarcinoma, pancreatic cancer, triple-negative breast cancer, non-small cell lung cancer, thymic carcinoma, gastric including gastroesophageal junction cancer
- Medical subject headings
- Neoplasms, Cholangiocarcinoma, Pancreatic Neoplasms, Triple Negative Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Cisplatin 25 mg/m2 IV administered on day 1 and day 8 of 21 day cycle, for up to maximum 6 cycles
GemcitabineDrug
Gemcitabine 1000 mg/m2 IV administered on days 1 and 8 of a 21-day cycle
Anetumab ravtansine (BAY94-9343)Drug
Anetumab ravtansine 6.5mg/kg IV in monotherapy indications. For combination indications, the MTD determined in safety lead in phase will be administered
| Study group | Role | What they receive |
|---|---|---|
| Cholangiocarcinoma | Experimental | Safety lead-in phase will determine the MTD of anetumab ravtansine administered in combination with cisplatin. Please note the study is no longer recruiting for the cholangiocarcinoma safety lead-in phase.
During the main study phase anetumab ravtansine will be administered at the determined MTD in combination with cisplatin. Please note the main study phase for cholangiocarcinoma will no longer be going ahead. Receives: Drug: Cisplatin; Drug: Anetumab ravtansine (BAY94-9343) |
| Adenocarcinoma of the pancreas | Experimental | Safety lead-in phase will determine the MTD of anetumab ravtansine administered in combination with gemcitabine During the main study phase, anetumab ravtansine will be administered at the determined MTD in combination with gemcitabine Receives: Drug: Gemcitabine; Drug: Anetumab ravtansine (BAY94-9343) |
| Other solid tumors | Experimental | (Non-small cell adenocarcinoma of the lung (NSCLC adenocarcinoma), Adenocarcinoma of the breast - triple negative (TNBC), Gastric adenocarcinoma including gastroesophageal junction (GEJ Cancer, Thymic carcinoma) During the main study phase, anetumab ravtansine will be administered at dose of 6.5 mg/kg in solid tumors Receives: Drug: Anetumab ravtansine (BAY94-9343) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 tumors
A 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)
Measured: 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 progression
Measured: Up to approximately 26 months after patient starts treatment
Secondary outcomes (6)
Number of serious and non-serious adverse events (AEs)
Include treatment-emergent AEs, SAEs, treatment-related AEs, AEs of special interest, and deaths.
Measured: 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.
Measured: 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 death
Measured: 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.
Measured: 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.
Measured: 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 cancer
A 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.
Measured: 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]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start26 May 2017
- Primary completion16 Sep 2020
- Study completion26 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ImmunoGen, Inc., MorphoSys AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102320
- Sponsor's protocol ID
- 15834
- Other IDs
- 2016-004002-33, 2016
- Acronym
- ARCS-Multi
- Status last verified
- Jun 2022
- First submitted
- 30 Mar 2017
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Multi-indication Study of Anetumab Ravtansine (BAY94-9343) in Patients With Mesothelin Expressing Advanced or Recurrent Malignancies
- ClinicalTrials.gov ID
- NCT03102320
- Acronym / sponsor ID
- ARCS-Multi / 15834
- Conditions
- Neoplasms
- Keywords
- cholangiocarcinoma, pancreatic cancer, triple-negative breast cancer, non-small cell lung cancer, thymic carcinoma, gastric including gastroesophageal junction cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- ImmunoGen, Inc., MorphoSys AG
- Study start
- 26 May 2017 (actual)
- Primary completion
- 16 Sep 2020 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cholangiocarcinoma | Experimental | Drug: Cisplatin, Drug: Anetumab ravtansine (BAY94-9343)Safety lead-in phase will determine the MTD of anetumab ravtansine administered in combination with cisplatin. Please note the study is no longer recruiting for the cholangiocarcinoma safety lead-in phase. During the main study phase anetumab ravtansine will be administered at the determined MTD in combination with cisplatin. Please note the main study phase for cholangiocarcinoma will no longer be going ahead. |
| Adenocarcinoma of the pancreas | Experimental | Drug: Gemcitabine, Drug: Anetumab ravtansine (BAY94-9343)Safety lead-in phase will determine the MTD of anetumab ravtansine administered in combination with gemcitabine During the main study phase, anetumab ravtansine will be administered at the determined MTD in combination with gemcitabine |
| Other solid tumors | Experimental | Drug: Anetumab ravtansine (BAY94-9343)(Non-small cell adenocarcinoma of the lung (NSCLC adenocarcinoma), Adenocarcinoma of the breast - triple negative (TNBC), Gastric adenocarcinoma including gastroesophageal junction (GEJ Cancer, Thymic carcinoma) During the main study phase, anetumab ravtansine will be administered at dose of 6.5 mg/kg in solid tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CisplatinCisplatin 25 mg/m2 IV administered on day 1 and day 8 of 21 day cycle, for up to maximum 6 cycles | Drug | Cholangiocarcinoma |
| GemcitabineGemcitabine 1000 mg/m2 IV administered on days 1 and 8 of a 21-day cycle | Drug | Adenocarcinoma of the pancreas |
| Anetumab ravtansine (BAY94-9343)Anetumab ravtansine 6.5mg/kg IV in monotherapy indications. For combination indications, the MTD determined in safety lead in phase will be administered | Drug | Adenocarcinoma of the pancreas, Cholangiocarcinoma, Other solid tumors |
Primary outcome
Number of patients in the safety lead-in (SLI) phase who completed Cycle 1 or had a DLT and were not replaced.
Time frame: At least 3 weeks after the last patient starts treatment
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.
Objective response (qualitative improvement from baseline) of anetumab ravtansine for monotherapy and combination therapy in mesothelin expressing advanced solid tumors
Time frame: Up to approximately 26 months after patient starts treatment
A 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)
Durable disease control (lack of progression from baseline) of anetumab ravtansine in indications pancreatic and gastric cancer (co-primary endpoint)
Time frame: Up to approximately 26 months after patient starts treatment
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 progression
6 secondary outcomes
Number of serious and non-serious adverse events (AEs)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 cancer
Time frame: 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]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
72 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cisplatin, Gemcitabine and Anetumab ravtansine (BAY94-9343) in people with Neoplasms, run by Bayer at 72 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States, France, Spain, Australia, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients in the safety lead-in (SLI) phase who completed Cycle 1 or had a DLT and were not replaced. (time frame: At least 3 weeks after the last patient starts treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.