Phase II Trial Of Gemcitabine Plus Nab-Paclitaxel +/- OGX-427 In Patients With Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: OGX-427; Placebo
Intervention description: Three separate administrations of OGX-427 will be given during the 9-day Loading Dose Period. Following the Loading Dose Period, patients will receive 600mg OGX-427 prior to the administration of nab-paclitaxel (125mg/m2 IV)and gemcitabine (1000mg/m2 IV)administration on Day 1, 8, and 15 of each cycle. OGX-427 will also be administered on Day 22 during each cycle (i.e., weekly). Patients will continue 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.; Three separate administrations of Placebo will be given during the 9-day Loading Dose Period. Following the Loading Dose Period, patients will receive placebo prior to the administration of nab-paclitaxel (125mg/m2 IV)and gemcitabine (1000mg/m2 IV)administration on Day 1, 8, and 15 of each cycle. Placebo will also be administered on Day 22 during each cycle (i.e., weekly). Patients will continue 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: untreated; metastatic; OGX-427

Summary:

      The purpose of this study is to compare the overall survival in patients with previously
      untreated metastatic pancreatic cancer receiving gemcitabine/nab-paclitaxel plus OGX-427 or
      gemcitabine/nab-paclitaxel plus placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically- or cytologically confirmed pancreatic adenocarcinoma

          2. Stage IV disease (measurable disease NOT required)

          3. Eastern Cooperative Oncology Group (ECOG) performance score of 0-1

          4. At least 18 years of age

          5. Female patients who are not of child-bearing potential, and fertile female patients of
             child-bearing potential who agree to use adequate contraceptive measures, who are not
             breastfeeding, and who have a negative serum or urine pregnancy test within 72 hours
             prior to start of randomization.

          6. Fertile male patients willing to use adequate contraceptive measures.

          7. Adequate bone marrow, renal, and hepatic function.

          8. Ability to understand the nature of this study protocol, comply with study and/or
             follow-up procedures, and give written informed consent

          9. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
             tests, and other study procedures.

        Exclusion Criteria:

          1. Any prior systemic or investigational therapy for metastatic pancreatic cancer.
             Systemic therapy administered alone or in combination with radiation in the adjuvant
             or neoadjuvant setting is permissible as long as it was completed > 6 months prior to
             the time of study randomization.

          2. History of other diseases, metabolic dysfunction, physical examination findings, or
             clinical laboratory findings giving reasonable suspicion of a disease or condition
             that, in the opinion of the investigator, renders the subject at high risk from
             treatment complications or might affect the interpretation of the results of the
             study.

          3. Presence of known central nervous system or brain metastases.

          4. Known human immunodeficiency virus (HIV) infection.

          5. Active second invasive malignancy (except non-melanomatous skin cancer), defined as
             any malignancy with current need for cancer therapy or high possibility (>30%) of
             recurrence during the study.

          6. Patients receiving warfarin. However, therapeutic anticoagulation with Low Molecular
             Weight Heparin (LMWH) is allowed.

          7. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic
             coronary artery disease, and cardiac arrhythmias not well controlled with medication)
             or myocardial infarction within the last 6 months.

          8. Current sensory neuropathy > Grade 1.

          9. Major surgery within 4 weeks of the start of study treatment (defined as those
             surgeries that require general anesthesia. Insertion of a vascular access device is
             NOT considered major surgery.). Patients must have recovered from the side effects of
             any major surgery prior to randomization.