Spots Global Cancer Trial Database for Phase II Anetumab Ravtansine in Pre-treated Mesothelin-expressing Pancreatic Cancer

Study Description

Brief Summary: 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)

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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