Phase II Anetumab Ravtansine in Pre-treated Mesothelin-expressing Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT03023722|
Recruitment Status : Completed
First Posted : January 18, 2017
Results First Posted : January 22, 2021
Last Update Posted : January 22, 2021
The primary objective of this study is to:
-Test the activity/response rate per RECIST 1.1 criteria of anetumab ravtansine in patients with advanced pancreatic cancer who stain for mesothelin expression
The secondary objectives of this study are to:
- Time to Progression (TTP) defined as time from study treatment to RECIST 1.1 progression, or death (others going off study will be censored)
- Toxicity in pancreatic cancer patients (at 6.5 mg/kg dose)
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: anetumab ravtansine||Phase 2|
This is a non-randomized, open-label, multicenter, Phase II study to evaluate the efficacy and safety of intravenous anetumab ravtansine (BAY 94-9343), an anti-mesothelin antibody drug conjugate, in pretreated mesothelin-expressing advanced pancreatic cancer.
At the time of the start of study treatment, the patients will have pretreated advanced pancreatic cancer that also overexpresses mesothelin as determined by immunohistochemistry (IHC).
A maximum of 30 patients will be enrolled in a minimax, Simon 2-stage design with a single early stopping rule for lack of efficacy. The target population is those patients with pancreatic cancer who have failed an earlier treatment. All patients will be treated with an anti-mesothelin immuno-conjugate, in this single arm, non-randomized trial and all patients treated with at least one dose of Anetumab will be included. The endpoint is any response using the RECIST 1.1 criteria.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Phase II Study of Intravenous Anetumab Ravtansine (BAY 94-9343), an Anti-mesothelin Antibody Drug Conjugate, in Pretreated Mesothelin-expressing Advanced Pancreatic Cancer|
|Actual Study Start Date :||May 11, 2017|
|Actual Primary Completion Date :||August 6, 2019|
|Actual Study Completion Date :||December 11, 2019|
Experimental: All Subjects
Patients with advanced metastatic pancreatic cancer who have measurable disease
Drug: anetumab ravtansine
Patients will receive anetumab ravtansine IV infusion at a dose of 6.5 mg/kg (recommended Phase II dose) on Day 1 of a 21-day cycle
- Response Rate as Measured Per RECIST 1.1 Criteria [ Time Frame: From start of treatment until disease progression or death (up to 3 years). ]Primary efficacy will be assessed based on radiological tumor evaluation by contrast-enhanced computed tomography (CT) or contrast-enhanced magnetic resonance imaging (MRI) of chest/abdomen/pelvis. Contrast enhanced RECIST 1.1 scan will be done at Prescreening. Said pre-screen scan will be the baseline measure. RECIST 1.1 Scans will be done every 6 weeks for the first 6 months after the start of treatment, or more frequently if clinically indicated, every 9 weeks until the end of year 2 and every 12 weeks thereafter until disease progression or end of study, whichever comes first.
- Time to Progression [ Time Frame: From start of treatment until disease progression or death (up to 3 years). ]Time to Progression (TTP) defined as time from study treatment to RECIST progression, or death (others going off study will be censored).
- Drug Toxicity [ Time Frame: From start of treatment until disease progression or death (up to 3 years). ]Toxicity of Anetumab ravtansine assessed with National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. See adverse events for details. Participants who experienced any adverse events are included here.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023722
|United States, Connecticut|
|Yale Cancer Center|
|New Haven, Connecticut, United States, 06510|
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08901-2163|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Stacey Stein, MD||Yale Cancer Center, Yale University|