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

Pancreatic Cancer Clinical Trial

— Rainier  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01844817
• Other study ID #: SCRI GI 184
• Status: Completed
• Phase: Phase 2
• First received: April 29, 2013
• Last updated: March 21, 2016
• Start date: August 2013
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Patients with pancreatic cancer usually present with inoperable disease and systemic therapy becomes the primary form of treatment. The combination of gemcitabine plus nab-paclitaxel represents an appropriate front-line standard of care for patients with metastatic pancreatic cancer. However, poor outcomes with this disease warrant exploration of novel drugs with unique mechanisms of action. Preclinical evidence suggests that OGX-427 has shown promising activity in pancreatic cancer. In this trial, we will compare the overall survival of patients with previously untreated metastatic pancreatic cancer using OGX-427 with either gemcitabine/nab-paclitaxel or a placebo with gemcitabine/nab-paclitaxel.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: March 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Tennessee Oncology - Chattanooga	Chattanooga	Tennessee
United States	Oncology Hematology Care, Inc.	Cincinnati	Ohio
United States	South Carolina Oncology Associates	Columbia	South Carolina
United States	The Center for Cancer and Blood Disorders	Fort Worth	Texas
United States	Florida Cancer Specialists-South	Ft. Myers	Florida
United States	Ingalls Cancer Research Center	Harvey	Illinois
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Florida Hospital Cancer Insitute	Orlando	Florida
United States	Virginia Cancer Institute	Richmond	Virginia
United States	University of California-San Francisco	San Francisco	California
United States	Florida Cancer Specialists-North	St. Petersburg	Florida

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	OncoGenex Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum Levels of Hsp27	Evaluate the effect of treatment with OGX-427 on serum HSP-27 levels	Every cycle (4 weeks)	No
Primary	Overall Survival	Overall survival for each arm will be assessed from date of randomization until death, using Kaplan-Meier method.	24 months	No
Secondary	Progression-Free Survival	To compare progression-free survival in each arm	Every 8 weeks	No
Secondary	Objective Response Rate	To compare objective response rate for each treatment arm	Every 8 weeks	No
Secondary	CA19-9 Levels	Compare CA19-9 levels between treatment arms of patients with elevated levels at baseline	Every cycle (4 weeks)	No
Secondary	Safety of the regimen	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	Continuous review	Yes