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Safety and Tolerability Study in Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences Identifier:
First received: February 27, 2013
Last updated: October 14, 2016
Last verified: October 2016

This is an open-label, multicenter, sequential dose-escalation, and expansion study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of GS-5745 alone and in combination with chemotherapy.

The study consists of 2 parts (Parts A and B). Participants can only qualify for and participate in 1 part.

Part A is a sequential dose escalation to determine the maximum tolerated dose of GS-5745 in participants with advanced solid tumors that are refractory to or intolerant to standard therapy or for which no standard therapy exists. In Part A, participants will receive GS-5745 only. Part A will consist of between 12 to 48 participants.

Part B is a dose expansion to obtain additional safety and tolerability data for GS-5745 in participants with advanced pancreatic adenocarcinoma, lung adenocarcinoma, lung squamous cell carcinoma, esophagogastric adenocarcinoma, colorectal cancer, or breast cancer. In Part B, participants will receive GS-5745 in combination with standard-of-care chemotherapy. Part B will consist of between 115 to 295 participants.

Please note the study is currently only recruiting in the colorectal and breast cancer cohorts.

Condition Intervention Phase
Pancreatic Cancer
Non-small Cell Lung Cancer
Esophagogastric Cancer
Colorectal Cancer
Breast Cancer
Drug: GS-5745
Drug: Gemcitabine
Drug: Nab-paclitaxel
Drug: Carboplatin
Drug: Pemetrexed
Drug: Leucovorin
Drug: Oxaliplatin
Drug: 5-FU
Drug: Bevacizumab
Drug: Irinotecan
Drug: Paclitaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5745 as Monotherapy and in Combination With Chemotherapy in Subjects With Advanced Solid Tumors

Resource links provided by NLM:

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Safety as evaluated by incidence of AEs, assessment of clinical laboratory test findings, physical examination, 12-lead ECG, and vital signs measurements [ Time Frame: Baseline to completion of follow up evaluation. If follow up evaluation is not completed, baseline to date of first documented progression or date of death from any cause, whichever came first ] [ Designated as safety issue: No ]
    AEs that begin on or after the first study drug administration and within 30 days after last study drug administration will be summarized by dose level (Part A) and tumor type (Part B).

Estimated Enrollment: 250
Study Start Date: March 2013
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GS-5745
Participants will receive GS-5745 by intravenous (IV) infusion over approximately 30 minutes every 2 weeks on Days 1 and 15 of each 28-day treatment cycle or every 3 weeks on Day 1 of each 21-day treatment cycle (NSCLC group only).
Drug: GS-5745
GS-5745 administered intravenously
Experimental: GS-5745 with chemotherapy

Participants will receive GS-5745 by IV infusion every 2-3 weeks in combination with chemotherapy as follows:

  • Pancreatic adenocarcinoma, esophagogastric adenocarcinoma, CRC, and breast cancer: Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
  • Non Small Cell Lung Carcinoma (NSCLC): Administered intravenously on Day 1 of each 21-day treatment cycle

In Part B, GS-5745 will be given in combination with one of the following chemotherapy regimens:

  • Pancreatic adenocarcinoma: gemcitabine and nab-paclitaxel
  • NSCLC:

    • lung adenocarcinoma: carboplatin and pemetrexed
    • lung squamous cell carcinoma: carboplatin and paclitaxel
  • Esophagogastric adenocarcinoma: mFOLFOX6 (leucovorin+oxaliplatin+5-FU)
  • First-line colorectal cancer (CRC): mFOLFOX6 and bevacizumab
  • Second-line colorectal cancer: FOLFIRI (leucovorin+irinotecan+5-FU) and bevacizumab
  • Breast cancer: Paclitaxel
Drug: GS-5745
GS-5745 administered intravenously
Drug: Gemcitabine
Gemcitabine administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle
Drug: Nab-paclitaxel
Nab-paclitaxel administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle
Drug: Carboplatin
Carboplatin administered intravenously on Day 1 of each 21-day treatment cycle
Drug: Pemetrexed
Pemetrexed administered intravenously on Day 1 of each 21-day treatment cycle
Drug: Leucovorin
Leucovorin administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Drug: Oxaliplatin
Oxaliplatin administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Drug: 5-FU
5-FU administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Drug: Bevacizumab
Bevacizumab administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Drug: Irinotecan
Irinotecan administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Drug: Paclitaxel
Paclitaxel administered intravenously on Days 1, 8 and 15 of each 28-day treatment cycle (Breast cancer) or on Day 1 of each 21-day treatment cycle (NSCLC)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Part A: histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of standard therapy or for which no standard therapy is available
  • Part B: Pancreatic Adenocarcinoma

    • Presence of histologically confirmed inoperable locally advanced or metastatic pancreatic adenocarcinoma
  • Part B: NSCLC

    • Stage IIIB with malignant pleural effusion/pleural seeding or stage IV histologically confirmed NSCLC
    • Absence of known epidermal growth factor receptor (EGFR) mutation
    • Absence of known translocation or inversion events involving the ALK gene locus (resulting in EML4-ALK fusion)
  • Part B: Esophagogastric Adenocarcinoma:

    • Histologically confirmed inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapsed gastric adenocarcinoma
    • Human epidermal growth factor receptor 2 (HER2)-negative tumor (primary tumor or metastatic lesion)
  • Part B: First-Line Colorectal Cancer

    • Histologically confirmed inoperable advanced adenocarcinoma of the colon or rectum
    • Radiographically measureable disease
    • No prior cytotoxic chemotherapy to treat their metastatic disease
  • Part B: Second-Line Colorectal Cancer

    • Histologically confirmed inoperable advanced adenocarcinoma of the colon or rectum
    • Radiographically measureable disease
    • Received first-line combination therapy containing oxaliplatin and fluoropyrimidine with or without bevacizumab for metastatic disease with documented evidence of disease progression during or after treatment completion
  • Part B: Breast Cancer

    • Histologically or cytologically confirmed metastatic breast cancer
    • Radiographically measureable disease
    • Previous hormonal therapy for metastatic breast cancer or cytotoxic adjuvant chemotherapy is allowed
    • Treatment with weekly single-agent paclitaxel is appropriate in the opinion of the treating physician
    • HER-2 negative tumor (primary tumor or metastatic lesion)
  • Adequate organ function

Exclusion Criteria:

  • Pregnant or lactating
  • Individuals with known central nervous system (CNS) metastases, unless metastases are treated and stable and the individual does not require systemic steroids
  • Myocardial infarction, symptomatic congestive heart failure, unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months
  • Anti-tumor therapy within 28 days of study drug dosing; concurrent use of hormone therapy for breast or prostate cancer is permitted
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01803282

United States, Alabama
Alabama Oncology Withdrawn
Birmingham, Alabama, United States, 35211
United States, Arizona
Pinnacle Oncology Hematology Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Patricia (Pat) Shannon    480-860-5000   
Principal Investigator: Michael Gordon, MD         
United States, California
Comprehensive Blood and Cancer Center Recruiting
Bakersfield, California, United States, 93309
Contact: Veronica Marquez    661-862-7122   
Principal Investigator: Ravindranath Patel, MD         
San Diego Pacific Oncology and Hematology Associates, Inc. Recruiting
Encinitas, California, United States, 92024
Contact: Brian Cox    760-452-3909   
Principal Investigator: Alberto Bessudo, MD         
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
Contact: Brenda Eng    415-600-1775   
Principal Investigator: Ari Baron, MD         
UCLA Medical Center Recruiting
Santa Monica, California, United States, 90404
Contact: Lisa Yonemoto    310-582-4069   
Principal Investigator: Zev Wainberg, MD         
Stanford University Withdrawn
Stanford, California, United States, 94305
United States, Florida
Florida Cancer Specialists Recruiting
Sarasota, Florida, United States, 34232
Contact: Jill Martin    941-377-9993 ext 319   
Principal Investigator: Manish Patel, MD         
United States, Indiana
Indiana University Health Goshen Center for Cancer Care Recruiting
Goshen, Indiana, United States, 46526
Contact: Helen Sivicek    574-364-2359   
Principal Investigator: Daniel Bruetman, MD         
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Melissa Meredith    314-362-4140   
Principal Investigator: Haeseong Park, MD         
United States, New York
Cornell University Recruiting
New York, New York, United States, 10021
Contact: Kelsey Collins-Garrison    646-962-9344   
Principal Investigator: Manish Shah, MD         
United States, South Carolina
Greenville Health System, Institute for Translational Oncology Research Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jill Cantrell    864-455-3737   
Principal Investigator: Ki Chung, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Sharon Calvert    615-329-7235   
Principal Investigator: Johanna Bendell, MD         
Vanderbilt Recruiting
Nashville, Tennessee, United States, 37212
Contact: Chelsea Henrichs    615-936-3698   
Principal Investigator: Jordan Berlin, MD         
United States, Texas
UT Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Jay Stafford    214-648-4260   
Principal Investigator: Saad Khan, MD         
United States, Utah
University of Utah Active, not recruiting
Salt Lake City, Utah, United States, 84112
United States, Washington
Northwest Medical Specialties Recruiting
Tacoma, Washington, United States, 98405
Contact: Sue Quinsey    253-428-8738   
Principal Investigator: Jorge Chaves, MD         
Sponsors and Collaborators
Gilead Sciences
Study Director: Gregory Vosganian, MD Gilead Sciences
  More Information

Responsible Party: Gilead Sciences Identifier: NCT01803282     History of Changes
Other Study ID Numbers: GS-US-296-0101 
Study First Received: February 27, 2013
Last Updated: October 14, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Solid Tumor

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Pancreatic Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Albumin-Bound Paclitaxel processed this record on October 26, 2016