Phase II Trial Of Gemcitabine Plus Nab-Paclitaxel +/- OGX-427 In Patients With Metastatic Pancreatic Cancer (Rainier)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by SCRI Development Innovations, LLC
Sponsor:
Collaborator:
OncoGenex Pharmaceuticals
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT01844817
First received: April 29, 2013
Last updated: April 22, 2014
Last verified: November 2013

April 29, 2013
April 22, 2014
August 2013
February 2016   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: Time from randomization until death ] [ Designated as safety issue: No ]
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)
Overall Survival [ Time Frame: 30 months ] [ Designated as safety issue: No ]
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)
Complete list of historical versions of study NCT01844817 on ClinicalTrials.gov Archive Site
  • Progression-Free Survival [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
    To compare progression-free survival in each arm
  • Objective Response Rate [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
    To compare objective response rate for each treatment arm
  • CA19-9 Levels [ Time Frame: Every cycle (4 weeks) ] [ Designated as safety issue: No ]
    To compare CA19-9 levels between treatment arms of patients with elevated levels at baseline
  • Safety of the regimen [ Time Frame: Continuous review ] [ Designated as safety issue: Yes ]
    To compare the safety/tolerability of gemcitabine/nab-paclitaxel/placebo with gemcitabine/nab-paclitaxel/OGX-427. Toxicities will be assessed using Common Terminology Criteria for Adverse Events v4.0
  • Progression-Free Survival [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    To compare progression-free survival in each arm
  • Objective Response Rate [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    To compare objective response rate for each treatment arm
  • CA19-9 Levels [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    To compare CA19-9 levels between treatment arms of patients with elevated levels at baseline
  • Safety of the regimen [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
    To compare the safety/tolerability of gemcitabine/nab-paclitaxel/placebo with gemcitabine/nab-paclitaxel/OGX-427. Toxicities will be assessed using Common Terminology Criteria for Adverse Events v4.0
Serum Levels of Hsp27 [ Time Frame: Every cycle (4 weeks) ] [ Designated as safety issue: No ]
To evaluate the effect of treatment with OGX-427 on serum HSP-27 levels
Serum Levels of Hsp27 [ Time Frame: 30 months ] [ Designated as safety issue: No ]
To evaluate the effect of treatment with OGX-427 on serum HSP-27 levels
 
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)

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pancreatic Cancer
  • Drug: OGX-427
    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.
  • Drug: Placebo
    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.
  • Experimental: OGX-427
    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.
    Intervention: Drug: OGX-427
  • Placebo Comparator: Placebo
    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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
132
May 2016
February 2016   (final data collection date for primary outcome measure)

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 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.
Both
18 Years and older
No
Contact: Sarah Cannon Research Institute (SCRI) 877-691-7274 asksarah@scresearch.net
United States
 
NCT01844817
SCRI GI 184
No
SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
OncoGenex Pharmaceuticals
Study Chair: Johanna Bendell, M.D. SCRI
SCRI Development Innovations, LLC
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP