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

NCT01844817 | Completed Phase 2 Results

• 1 other identifier: SCRI GI 184
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Pancreatic Cancer

Keywords

untreated; metastatic; OGX-427

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall survival defined as the time, in months, from date of randomization until date of death or date last known alive whichever comes first, assessed up to 2 years.

  Up to 2 years

Secondary Outcomes (2)

• Progression-Free Survival

  Every 8 weeks up to 2 years

• Objective Response Rate

  Every 8 weeks for up to 2 years

Study Arms (2)

OGX-427

EXPERIMENTAL

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.

Drug: OGX-427

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

OGX-427 DRUG

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.

OGX-427

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically- or cytologically confirmed pancreatic adenocarcinoma
• Stage IV disease (measurable disease NOT required)
• Eastern Cooperative Oncology Group (ECOG) performance score of 0-1
• At least 18 years of age
• 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.
• Fertile male patients willing to use adequate contraceptive measures.
• Adequate bone marrow, renal, and hepatic function.
• Ability to understand the nature of this study protocol, comply with study and/or follow-up procedures, and give written informed consent
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

You may not qualify if:

• 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.
• 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.
• Presence of known central nervous system or brain metastases.
• Known human immunodeficiency virus (HIV) infection.
• 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.
• Patients receiving warfarin. However, therapeutic anticoagulation with Low Molecular Weight Heparin (LMWH) is allowed.
• 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.
• Current sensory neuropathy \> Grade 1.
• 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.

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Achieve Life Sciences: collaborator

Study Sites (11)

University of California-San Francisco

San Francisco, California, 94115, United States

Location

Florida Cancer Specialists-South

Fort Myers, Florida, 33916, United States

Location

Florida Hospital Cancer Insitute

Orlando, Florida, 32804, United States

Location

Florida Cancer Specialists-North

St. Petersburg, Florida, 33705, United States

Location

Ingalls Cancer Research Center

Harvey, Illinois, 60426, United States

Location

Oncology Hematology Care, Inc.

Cincinnati, Ohio, 45242, United States

Location

South Carolina Oncology Associates

Columbia, South Carolina, 29210, United States

Location

Tennessee Oncology - Chattanooga

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

The Center for Cancer and Blood Disorders

Fort Worth, Texas, 76104, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23230, United States

Location

Related Publications (1)

• Ko 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 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Interventions

apatorsen

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Charles Davis, RAC
• Organization: Sarah Cannon Development Innovations

Charles.Davis2@scri-innovations.com

Study Officials

• Johanna Bendell, M.D.

  SCRI

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 1, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 16, 2017
• Results First Posted: May 16, 2017

Record last verified: 2017-02

Locations

US (11)