Patients must have a histologic diagnosis of pancreatic adenocarcinoma
Cytologically- or histologically-confirmed pancreatic adenocarcinoma or poorly differentiated pancreatic carcinoma that is metastatic to distant sites\r\n* Other histologies such as neuroendocrine and acinar cell carcinoma are excluded
Procurement: Any patient with biopsy proven pancreatic adenocarcinoma
Any patient with biopsy-proven pancreatic adenocarcinoma:\r\n* Group A: Patients with locally advanced or metastatic pancreatic adenocarcinoma who experienced a documented best response of investigator-assessed confirmed partial response (PR) or stable disease (SD) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v).\r\n* Group B: Patients with locally advanced or metastatic pancreatic adenocarcinoma who experienced progressive disease following first line chemotherapy or who are judged by the investigator as being ineligible to receive standard of care chemotherapy\r\n* Group C: Patients with potentially resectable pancreatic cancer who have completed planned preoperative neo-adjuvant chemotherapy, radiotherapy or combination chemoradiation
Pancreatic ductal adenocarcinoma (PDAC)
Histologically or cytologically-confirmed metastatic pancreatic ductal adenocarcinoma.
Must have histologically or cytologically confirmed advanced pancreatic ductal adenocarcinoma (PDAC) that is metastatic. The definitive diagnosis of metastatic PDAC will be made by integrating the histopathological data within the context of the clinical and radiographic data. Patients with islet cell neoplasms are excluded.
Confirmed diagnosis of borderline resectable or locally advanced pancreatic adenocarcinoma
The patient has a histologically or cytologically confirmed metastatic pancreatic adenocarcinoma.
Pancreatic adenocarcinoma.
EXPANSION COHORT: No more than one line of prior systemic therapy for advanced pancreatic adenocarcinoma allowed
Patients must have a histologically or cytologically confirmed pancreatic adenocarcinoma that is metastatic, unresectable, or recurrent
Subjects must have a histologically confirmed pancreatic adenocarcinoma that has had an R (negative margins) or R (microscopically positive margins) resection
Histologically or cytologically proven pancreatic adenocarcinoma (subjects with endocrine or acinar pancreatic carcinoma are not eligible)
Cytologic or biopsy confirmed adenocarcinoma of the pancreatic head, body or tail
Have histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma
Histologically confirmed pancreatic adenocarcinoma with initial diagnosis within weeks of consent
Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma; mixed histology will be included as long as the predominant histology is adenocarcinoma
Histologically or cytologically confirmed, previously treated, locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA- positive malignancies
Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma that has progressed on one or more chemotherapy regimens.
Patient must have pathologically confirmed, locally advanced or metastatic pancreatic ductal adenocarcinoma (PDA) deemed surgically unresectable by a surgeon with expertise in pancreatic cancer
The presence of metastatic pancreatic adenocarcinoma
Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non- adenocarcinoma (i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma
Patients must have metastatic histologically or cytologically confirmed pancreatic adenocarcinoma or sarcoma (soft tissue or bone) for which progression was documented for at least one line of therapy
Pancreatic ductal adenocarcinoma: ) pancreatic ductal adenocarcinoma patient with KRAS point mutation at codon G or G; in addition to the above inclusion criteria, first patients from both non-small cell lung cancer and pancreatic ductal adenocarcinoma patients will need to agree to mandatory pre- and post-treatment tumor biopsies
Have histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma based on pathology report
Histologically or cytological confirmed diagnosis of metastatic or locally advanced, unresectable pancreatic adenocarcinoma (excluding other pancreatic malignancies for example, acinar cell carcinomas, adenosquamous carcinomas, and neuroendocrine islet cell neoplasms).
Pancreatic Cancer Cohort: Patients must have a diagnosis of locally advanced or metastatic pancreatic adenocarcinoma previously treated with or not a candidate for standard of care systemic therapy.
Histologically confirmed, locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA- positive malignancies
Patients with histologically proven, surgically unresectable, locally advanced pancreatic adenocarcinoma (at diagnosis) or with mixed cell type with predominant histology of adenocarcinoma (by NCCN guidelines)
Patients must have metastatic pancreatic ductal adenocarcinoma (PDA) or metastatic colorectal cancer (CRC) to be eligible; (PDA patients with an elevated tumor marker following a primary pancreatic surgery would be eligible)
ARM A COHORT : Patients must have advanced pancreatic adenocarcinoma (unresectable or metastatic)
Pathologic or cytologic documentation of pancreatic adenocarcinoma
Biopsy proven pancreatic adenocarcinoma
Any pancreatic adenocarcinoma that does not meet criteria for borderline resectable disease
Group : Pancreatic Ductal Adenocarcinoma (Part B)
Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
Histologically or cytologically confirmed locally advanced or borderline resectable pancreatic ductal adenocarcinoma. Patients with clinical suspicion of pancreatic adenocarcinoma can be enrolled for pre-treatment biopsy, and must be histologically confirmed to have adenocarcinoma before being treated on study. Patients with squamous carcinoma, adenosquamous carcinoma or neuroendocrine tumor will be excluded
Cytologically confirmed pancreatic adenocarcinoma
Metastatic colorectal, pancreatic, gastroesophageal or biliary tract adenocarcinoma not amenable to curative resection
Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with locally advanced or metastatic disease
Have localized pancreatic ductal adenocarcinoma (PDA)s at the time of original diagnosis without any definitive evidence of distant metastatic disease
Histologically documented diagnosis of pancreatic adenocarcinoma
Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma that is metastatic or unresectable; in the dose expansion phase, the tumor must express AR by immunohistochemistry; if >= % of the tumor cells express AR, it will be considered positive for this trial
Patients must have histologically or cytologically-confirmed pancreatic adenocarcinoma
Cytologically or histologically confirmed pancreatic adenocarcinoma (excluding islet cell or ampullary tumors) that is metastatic or unresectable
Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma
Patients must have histologically or cytologically proven pancreatic adenocarcinoma; histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible
Patients must have histologically or cytologically documented pancreatic adenocarcinoma; patients with pancreatic neuroendocrine tumors, lymphoma of the pancreas, or ampullary cancer are not eligible
Patients must have newly diagnosed, untreated metastatic histologically or cytologically documented pancreatic adenocarcinoma; patients must not have known history of brain metastases
Part B: Pancreatic Adenocarcinoma
Presence of histologically confirmed inoperable locally advanced or metastatic pancreatic adenocarcinoma
Histologically confirmed (either previously or newly biopsied) metastatic unresectable pancreatic adenocarcinoma, including with intraductal papillary mucinous neoplasm.
Patients with locally advanced unresectable pancreatic ductal adenocarcinoma are excluded.
Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)
Subjects must have histologically or cytologically confirmed metastatic pancreatic adenocarcinoma; subjects with islet cell neoplasms are excluded
Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.
Histologically or cytologically confirmed locally advanced or metastatic pancreatic adenocarcinoma, gastric adenocarcinoma, cholangiocarcinoma, gall bladder adenocarcinoma, ampullary carcinoma, adenocarcinoma of unclear primary (with a gastrointestinal primary suspected), or other primary gastrointestinal malignancy for which the treating physician feels that FOLFIRABRAX is a reasonable therapeutic option
Subjects must have histologically or cytologically confirmed untreated metastatic pancreatic adenocarcinoma; subjects with islet cell neoplasms are excluded; subjects with mixed histology will be excluded
Prior therapy for pancreatic adenocarcinoma
Histologically confirmed cancer (one of the following):\r\n* Metastatic pancreatic adenocarcinoma
Patients must have histologically or cytologically diagnosed pancreatic adenocarcinoma; documentation of disease extent by computed tomography (CT) scan is required; radiologically measurable disease is not required
Patients must have histologically or cytologically confirmed metastatic pancreatic adenocarcinoma (or any mixed pathology if adenocarcinoma is predominant)
Patients must have histopathological confirmation of pancreatic adenocarcinoma prior to entering this study
Histologically or cytologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma. Patients with acinar cell carcinoma may also be included.
Received and failed, or were intolerant to, at least prior systemic therapy for locally advanced or metastatic pancreatic ductal adenocarcinoma.
Patients with any type of recurrent pancreatic adenocarcinoma
Histologically or cytologically confirmed pancreatic adenocarcinoma
Histologically confirmed pancreatic adenocarcinoma
Patients must have histologically or cytologically confirmed metastatic pancreatic adenocarcinoma (or any mixed pathology if adenocarcinoma is predominant)
Histologically or cytologically confirmed advanced pancreatic ductal adenocarcinoma that is unresectable or metastatic
Histologically or cytologically proven metastatic or inoperable pancreatic adenocarcinoma
Histologically or cytologically confirmed non-resectable pancreatic adenocarcinoma with or without metastases
Patients with metastatic pancreatic adenocarcinoma not treated with chemotherapy for metastatic disease
Pancreatic adenocarcinoma for which treatment with FOLFOX, CAPOX, FOLFIRI, or irinotecan would be acceptable as determined by the Investigator.
Eligibility for the expansion cohort: histologically or cytologically confirmed metastatic or unresectable pancreatic adenocarcinoma for which curative treatment does not exist
Non metastatic pancreatic ductal adenocarcinoma
Histologically and cytologically confirmed metastatic pancreatic adenocarcinoma
Histologically or cytologically confirmed locally advanced or metastatic pancreatic adenocarcinoma, colorectal adenocarcinoma, gastric adenocarcinoma, cholangiocarcinoma, gall bladder adenocarcinoma, ampullary carcinoma, adenocarcinoma of unclear primary (with a gastrointestinal primary suspected), or other primary gastrointestinal malignancy for which the treating physician feels that mFOLFIRINOX is a reasonable therapeutic option
The patient has histologically or cytologically confirmed pancreatic adenocarcinoma.
Participants must have histologically or cytologically confirmed locally advanced or metastatic pancreatic adenocarcinoma
Patient must have received no previous radiotherapy, surgical resection, chemotherapy or investigational drug therapy for pancreatic adenocarcinoma
Patients who have had previous radiotherapy, surgical resection, chemotherapy or investigational drug therapy for pancreatic adenocarcinoma
Histologically proven pancreatic adenocarcinoma with radiographically measurable OR evaluable metastatic disease
Histologically or cytologically confirmed diagnosis of an advanced nonhematological malignancy (Part A) or advanced pancreatic adenocarcinoma (Part B) that is not surgically resectable
The presence of metastatic pancreatic adenocarcinoma plus of the following:
Histological diagnosis of pancreatic adenocarcinoma confirmed pathologically, OR
Prior systemic chemotherapy treatment for metastatic pancreatic ductal adenocarcinoma (Arm: idelalisib single agent only)
Received one prior line of chemotherapy for metastatic pancreatic ductal adenocarcinoma (Arm: idelalisib + mFOLFOX only)
Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma (eg, lymphoma, sarcoma), adenocarcinoma originating from the biliary tree or cystadenocarcinoma
Mesothelin-positive refractory/recurrent solid tumors, other than malignant pleural mesothelioma (MPM) and pancreatic ductal adenocarcinoma (PDA) (Group only)
Presence of metastatic pancreatic adenocarcinoma plus of the following:
Histological diagnosis of pancreatic adenocarcinoma confirmed pathologically, OR
A history of resected pancreatic adenocarcinoma
Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma, adenocarcinoma originating from the biliary tree or cystadenocarcinoma
Confirmed pancreatic ductal adenocarcinoma
PANCREATIC CANCER COHORT (COHORT ONLY): Subjects with recurrent, locally advanced unresectable or metastatic adenocarcinoma of the pancreas; the diagnosis will be confirmed by the Laboratory of Pathology/CCR/NCI
Histologically or cytologically confirmed diagnosis of inoperable colorectal adenocarcinoma, pancreatic, hepatocellular, cholangiocarcinoma, small bowel, gastric or esophageal adenocarcinoma that carries an activated ALK or ROS pathway
Histologic documentation of incurable, locally advanced, or metastatic pancreatic ductal adenocarcinoma consisting of unresectable pancreatic ductal adenocarcinoma (i.e., participants who are not considered eligible for surgical resection with curative intent), including recurrence of previously resected disease
Patients must have a histologically confirmed, unresectable pancreatic adenocarcinoma
Histologically or cytologically proven pancreatic carcinoma or adenocarcinoma; histologies other than carcinoma/adenocarcinoma will not be eligible
Non- metastasis, unresectable, adenocarcinoma pancreatic cancer patients
Subjects must have histologically confirmed metastatic pancreatic ductal adenocarcinoma.. Prior chemotherapy and/or radiotherapy either in the adjuvant or neoadjuvant setting or for metastatic disease is not allowed.
Histologically or cytologically confirmed solid tumor (Part ) or pancreatic adenocarcinoma (Part )
Histologically documented, incurable, locally advanced or metastatic disease for which no standard therapy exists, consisting of one of the following: Unresectable pancreatic ductal adenocarcinoma or platinum-resistant ovarian cancer
Resectable pancreatic adenocarcinoma
Pathologic diagnosis of pancreatic adenocarcinoma
The subject has a resectable tumor or cyst arising from the pancreatic exocrine gland (pancreatic ductal adenocarcinoma, intraductal papillary mucinous neoplasm of the pancreas, or mucinous cystic neoplasm of the pancreas) and is undergoing surgical resection of the neoplasm
Phase II: Patients with histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma that have not received systemic chemotherapy for advanced or metastatic disease; the definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data
Phase II: Patients that previously received systemic chemotherapy for metastatic or advanced pancreatic adenocarcinoma are not eligible
Pancreatic adenocarcinoma, biopsy-proven or suspected
Histologically confirmed resectable or borderline resectable pancreatic adenocarcinoma; pathology report form
Personal history of pancreatic adenocarcinoma
History of pancreatic adenocarcinoma (at any time)
Patient to undergo pancreaticoduodenectomy for pancreatic ductal adenocarcinoma at the Johns Hopkins Hospital
Pancreaticoduodenectomy for an indication that is not pancreatic ductal adenocarcinoma (PDAC)
Clinically suspected or biopsy-confirmed diagnosis of pancreatic adenocarcinoma
Patients with histologically confirmed pancreatic adenocarcinoma (borderline resectable or locally advanced disease at presentation) are eligible for the study
Patients should not have any type of curative or palliative therapy for pancreatic adenocarcinoma before enrolling in the study
Subjects who had prior chemotherapy or radiotherapy for pancreatic adenocarcinoma cannot participate in the study
Histologically confirmed, locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other malignancies known to express CA- positive malignancies
GROUPS , , AND : Group participants must have pathologically- confirmed pancreatic adenocarcinoma and have been determined to have the need for neoadjuvant chemotherapy prior to surgical resection
Clinically suspected or biopsy-confirmed diagnosis of pancreatic adenocarcinoma
Prior resection for pancreatic adenocarcinoma
Subject has histologically or cytologically documented diagnosis of pancreatic adenocarcinoma with metastatic disease. Locally advanced subjects are not eligible.
Subject must be expected to undergo a clinically indicated surgical resection of histologically confirmed or suspected pancreatic ductal adenocarcinoma
Histologically-confirmed diagnosis of pancreatic adenocarcinoma, mesothelioma,\r\nmesothelin-positive ovarian cancer, or NSCLC; a new biopsy is not required; the diagnostic biopsy sample will be sufficient; IHC confirmation of mesothelin positivity is not necessary for pancreatic adenocarcinoma and mesothelioma; mesothelin expression in ovarian cancer and NSCLC will be tested by IHC, and any degree of positivity (+, +, or +) will be accepted
Histologically or cytologically confirmed pancreatic ductal adenocarcinoma