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A Randomized, Double-Blinded, Placebo-Controlled Phase II Trial Of Gemcitabine Plus Nab-Paclitaxel Combined With OGX-427 Or Placebo In Patients With Metastatic Pancreatic Cancer (The Rainier Trial)

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

A Randomized, Double-Blinded, Placebo-Controlled Phase II Trial Of Gemcitabine Plus Nab-Paclitaxel Combined With OGX-427 Or Placebo In Patients With Metastatic Pancreatic Cancer (The Rainier Trial)

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 function:

- Absolute neutrophil count (ANC) ≥ 1500/uL

- platelet count ≥ 100,000/uL

- hemoglobin ≥ 9.0 g/dL

8. Adequate hepatic function:

- Total bilirubin ≤ 1.5 X ULN

- Aspartate amino transferase (AST) (SGOT) ≤ 3.0 X ULN

- Alanine aminotransferase (ALT) (SGPT) ≤ 3.0 X ULN

9. Adequate renal function (defined as serum creatinine ≤ 1.5 X ULN)

10. Ability to understand the nature of this study protocol, comply with study and/or
follow-up procedures, and give written informed consent

11. 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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

To compare the overall survival in patients with previously untreated metastatic pancreatic cancer receiving gemcitabine/nab-paclitaxel plus OGX-427 versus gemcitabine/nab-paclitaxel plus placebo)

Outcome Time Frame:

30 months

Safety Issue:


Principal Investigator

Johanna Bendell, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2013

Completion Date:

December 2015

Related Keywords:

  • Pancreatic Cancer
  • untreated
  • metastatic
  • OGX-427
  • Pancreatic Neoplasms