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Safety and Tolerability Study in Solid Tumors

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ClinicalTrials.gov Identifier: NCT01803282
Recruitment Status : Active, not recruiting
First Posted : March 4, 2013
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:

This is an open-label, multicenter, sequential dose-escalation, and expansion study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of andecaliximab (formerly 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 andecaliximab 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 andecaliximab 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 andecaliximab 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 andecaliximab 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 breast cancer cohorts.


Condition or disease Intervention/treatment Phase
Tumors Pancreatic Cancer Non-small Cell Lung Cancer Esophagogastric Cancer Colorectal Cancer Breast Cancer Drug: Andecaliximab 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  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : March 29, 2013
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Arm Intervention/treatment
Experimental: Andecaliximab
Participants will receive andecaliximab 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: Andecaliximab
Administered intravenously
Other Name: GS-5745
Experimental: Andecaliximab with chemotherapy

Participants will receive andecaliximab 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, andecaliximab 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: Andecaliximab
Administered intravenously
Other Name: GS-5745
Drug: Gemcitabine
Administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle
Drug: Nab-paclitaxel
Administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle
Drug: Carboplatin
Administered intravenously on Day 1 of each 21-day treatment cycle
Drug: Pemetrexed
Administered intravenously on Day 1 of each 21-day treatment cycle
Drug: Leucovorin
Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Drug: Oxaliplatin
Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Drug: 5-FU
Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Drug: Bevacizumab
Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Drug: Irinotecan
Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Drug: 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)



Primary Outcome Measures :
  1. 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 ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key 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

Key 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803282


Locations
United States, Alabama
Alabama Oncology
Birmingham, Alabama, United States, 35213
United States, Arizona
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States, 85258
United States, California
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
San Diego Pacific Oncology and Hematology Associates, Inc.
Encinitas, California, United States, 92024
University of Southern California (USC)
Los Angeles, California, United States, 90033
California Pacific Medical Center
San Francisco, California, United States, 94115
UCLA Medical Center
Santa Monica, California, United States, 90404
United States, Florida
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
United States, Indiana
Parkview Research Center
Fort Wayne, Indiana, United States, 46845
Indiana University Health Goshen Center for Cancer Care
Goshen, Indiana, United States, 46526
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
Cornell University
New York, New York, United States, 10021
United States, South Carolina
Greenville Health System, Institute for Translational Oncology Research
Greenville, South Carolina, United States, 29605
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Vanderbilt
Nashville, Tennessee, United States, 37212
United States, Texas
UT Southwestern
Dallas, Texas, United States, 75390
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
United States, Washington
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01803282     History of Changes
Other Study ID Numbers: GS-US-296-0101
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gilead Sciences:
Solid Tumor
NSCLC
Pancreatic
Esophagogastric
Colorectal
Breast

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
Neoplasms
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
Paclitaxel
Irinotecan
Gemcitabine
Oxaliplatin
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin