The aim of this study is to see how well an investigational drug (calledBBI-608) works when it is given in combination with a standard anticancertreatment for people with advanced pancreatic cancer.
- Conditions
- This study will enroll patients with histologically or cytologically confirmed adenocarcinoma of the pancreas that is metastatic (Stage IV).MedDRA version: 20.0Level: LLTClassification code 10033599Term: Pancreatic adenocarcinoma metastaticSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-004359-57-BE
- Lead Sponsor
- Boston Biomedical, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1132
This study will enroll patients with histologically or cytologically confirmed adenocarcinoma of the pancreas that is metastatic (Stage IV). Patients with local recurrence following surgical resection will be excluded. At randomization, patients will not have received systemic chemotherapy for metastatic pancreatic adenocarcinoma previously (with a fluoropyrimidine or gemcitabine administered as a radiation sensitizer in the adjuvant setting allowed). Other inclusion criteria for all patients include: age = 18 years; ECOG performance status = 1; and adequate hepatic, renal, and bone-marrow function.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 680
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 452
-Patients with no evidence of metastatic disease as well as patients with a local recurrence following surgical resection of primary lesion.
-Patient has experienced a decline in ECOG performance status between Baseline visit and within 72 hours prior to randomization.
-Patient has a > or = 20% decrease in serum albumin level between Baseline visit and within 72 hours prior to randomization.
-Patient has a > 10% decrease in weight between Baseline visit and within 72 hours prior to randomization.
-Any prior anti-cancer chemotherapy, biologic or investigational therapy for PDAC.
-Major surgery within 4 weeks prior to randomization.
-Any known brain or leptomeningeal metastases are excluded, even if treated.
-Patients with clinically significant ascites or pleural effusions.
-Women who are pregnant or breastfeeding. Women should not breastfeed while taking study treatment and for 4 weeks after the last dose of BBI-608 or while undergoing treatment with nab-paclitaxel and gemcitabine and for 180 days after the last dose of nab-paclitaxel and gemcitabine.
-Gastrointestinal disorder(s) which, in the opinion of the Principal Investigator, would significantly impede the absorption of an oral agent (e.g. active Crohn’s disease, ulcerative colitis, extensive gastric and small intestine resection).
-Unable or unwilling to swallow BBI-608 capsules daily.
-Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements.
-Known hypersensitivity to gemcitabine, taxanes or any of their excipients, or the patient exhibits any of the events outlined in the Contraindications or Special Warnings and Precautions sections of the product or comparator SmPC or Prescribing Information. Possible hypersensitivity to BBI-608 or one of the excipients which include the azo dyes sunset yellow and allura red.
-Neurosensory neuropathy > or = grade 2 at baseline.
-Uncontrolled chronic diarrhea > or = grade 2 at baseline.
-Patients being treated with Warfarin.
-Patients with active, uncontrolled bacterial, viral or fungal infection(s) requiring systemic therapy
-Patients with a history of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated by surgery alone or surgery plus radiotherapy with no evidence of disease continuously for > or = 5 years.
-Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.
-Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol, including patients with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol. Patients planning to take a vacation for 7 or more consecutive days during the course of the study are ineligible.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method