Clinical trial · Interventional
Phase II Trial Of Gemcitabine Plus Nab-Paclitaxel +/- OGX-427 In Patients With Metastatic Pancreatic Cancer
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)
NCT01844817CI-TRIAL-00027591RainiercompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OGX-427 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- OGX-427
- description
- Three loading doses of OGX-427 at 600mg IV will be administered Days -9 to -1. Following the loading dose period, OGX-427 will be administered at 600mg IV weekly Days 1, 8, 15, and 22 of each 28 day cycle during the Treatment Phase.
- interventionNames
- Drug: OGX-427
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Three loading doses of placebo will be administered Days -9 to -1. Following the loading dose period, placebo will be administered weekly Days 1, 8, 15, and 22 of each 28 day cycle.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Overall Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDKo AH, Murphy PB, Peyton JD, Shipley DL, Al-Hazzouri A, Rodriguez FA, Womack MS 4th, Xiong HQ, Waterhouse DM, Tempero MA, Guo S, Lane CM, Earwood C, DeBusk LM, Bendell JC. A Randomized, Double-Blinded, Phase II Trial of Gemcitabine and Nab-Paclitaxel Plus Apatorsen or Placebo in Patients with Metastatic Pancreatic Cancer: The RAINIER Trial. Oncologist. 2017 Dec;22(12):1427-e129. doi: 10.1634/theoncologist.2017-0066. Epub 2017 Sep 21. PMID 28935773