Phase II Anetumab Ravtansine in Pre-treated Mesothelin-expressing Pancreatic Cancer (NCT03023722) | Clinical Trial Compass
CompletedPhase 2
Phase II Anetumab Ravtansine in Pre-treated Mesothelin-expressing Pancreatic Cancer
United States18 participantsStarted 2017-05-11
Plain-language 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)
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Eligibility criteria for prescreening
* Must have had at least one and not more than two prior chemotherapy regimens for advanced disease (neoadjuvant or adjuvant chemotherapy would not be counted as a line of therapy). If prior radiation, measurable lesion outside radiation portal.
* Written informed consent for prescreening.
* Unresectable locally advanced or metastatic pancreatic cancer, confirmed by histology
* Availability of archival or fresh tissue for testing of mesothelin expression level.
Note: Archival tissue is preferred and fresh biopsy should only be obtained if no archival tissue is available and if in the investigator's judgement, there is no additional risk for the patient's safety. Patients with a sarcomatoid histology are not expected to have mesothelin overexpression and should not enter prescreening.
* Age ≥ 18 years.
* Life expectancy of at least 3 months.
* No prior treatment with anetumab ravtansine (or any other mesothelin-based therapy)
Eligibility criteria for full study
* Written informed consent for full study.
* Histological documentation of overexpressing mesothelin at the moderate (2+) or stronger (3+) level in at least 30% of tumor cells as determined by IHC.
* Unresectable locally advanced or metastatic pancreatic cancer
* At least one but not more than two prior chemotherapy regimens with progression or documented intolerance (neoadjuvant or adjuvant chemotherapy would not be counted as a line of therapy).
* Patient…
What they're measuring
1
Response Rate as Measured Per RECIST 1.1 Criteria
Timeframe: From start of treatment until disease progression or death (up to 3 years).