Breast Cancer Clinical Trial
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
Verified date | May 2020 |
Source | Gilead Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of the study is to determine the maximum tolerated dose of
andecaliximab monotherapy and to evaluate the safety and tolerability 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 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.
Status | Completed |
Enrollment | 236 |
Est. completion date | April 23, 2019 |
Est. primary completion date | April 23, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Comprehensive Blood and Cancer Center | Bakersfield | California |
United States | Alabama Oncology | Birmingham | Alabama |
United States | UT Southwestern | Dallas | Texas |
United States | San Diego Pacific Oncology and Hematology Associates, Inc. | Encinitas | California |
United States | Parkview Research Center | Fort Wayne | Indiana |
United States | Indiana University Health Goshen Center for Cancer Care | Goshen | Indiana |
United States | Greenville Health System, Institute for Translational Oncology Research | Greenville | South Carolina |
United States | University of Southern California (USC) | Los Angeles | California |
United States | Sarah Cannon Research Institute | Nashville | Tennessee |
United States | Vanderbilt | Nashville | Tennessee |
United States | Cornell University | New York | New York |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | University of Utah | Salt Lake City | Utah |
United States | California Pacific Medical Center | San Francisco | California |
United States | UCLA Medical Center | Santa Monica | California |
United States | Florida Cancer Specialists | Sarasota | Florida |
United States | Pinnacle Oncology Hematology | Scottsdale | Arizona |
United States | Northwest Medical Specialties | Tacoma | Washington |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
United States,
Bendell J, Huang X, Smith V, Maltzman J, Starodub A. Results of a phase I study of GS-5745 in combination with gemcitabine and nab-paclitaxel in patients (pts) with advanced pancreatic cancer [abstract e15683] 2016. J Clin Oncol 34 supplemental
Bendell J, Patel M, Brachmann C, Huang X, Maltzman J, Smith V, et al. Updated results of a phase 1 study combining the matrix metalloproteinase 9 inhibitor GS-5745 with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer [Abstract 3
Bendell J, Starodub A, Sharma S, Wainberg Z, Shah M, Thai D. Phase I Study of GS-5745 Alone and in Combination with Chemotherapy in Patients with Advanced Solid Tumors [Poster 4030]. American Society of Clinical Oncology (ASCO) 51st Annual Meeting; 2015 2
Brachmann C, Zhang Y, Zavodovskaya M, Hu J, Maltzman J, Smith V, et al. Evaluating collagen neoepitopes as pharmacodynamic biomarkers of GS-5745, an MMP9 inhibitor, in advanced gastric cancer [Abstract 58] 2017 American Society of Clinical Oncology Gastro
Juric V, Mikels-Vigdal A, O'Sullivan C, Greenstein A, Stefanutti E, Barry-Hamilton V, et al. Inhibition of MMP9 improves anti-tumor immunity by changing the tumor microenvironment to promote T cell trafficking and activation. [Abstract 653/27]. 2017 Ameri
Lenz H, Park H, Shah MA, Berlin JD, Bruetman D, Chaves J, et al. Results of a phase I study of andecaliximab in combination with mFOLFOX6 and bevacizumab in patients with previously untreated metastatic colorectal cancer. Annals of Oncology (2018) 29 (sup
Marshall DC, Lyman SK, McCauley S, Kovalenko M, Spangler R, Liu C, Lee M, O'Sullivan C, Barry-Hamilton V, Ghermazien H, Mikels-Vigdal A, Garcia CA, Jorgensen B, Velayo AC, Wang R, Adamkewicz JI, Smith V. Selective Allosteric Inhibition of MMP9 Is Efficaci — View Citation
Shah M, Starodub A, Wainberg Z, Smith V, Maltzman J, Bendell J. Results of a phase I study of GS-5745 in combination with mFOLFOX in patients with advanced unresectable gastric / GE junction tumors [Poster 4033]. American Society of Clinical Oncology (ASC
Shah MA, Starodub A, Sharma S, Berlin J, Patel M, Wainberg ZA, Chaves J, Gordon M, Windsor K, Brachmann CB, Huang X, Vosganian G, Maltzman JD, Smith V, Silverman JA, Lenz HJ, Bendell JC. Andecaliximab/GS-5745 Alone and Combined with mFOLFOX6 in Advanced G — View Citation
Wainberg Z, Bendell J, Lenz H, Baron A, Berlin J, Bessudo A, et al. Results from a phase I study of andecaliximab in combination with FOLFIRI and bevacizumab in patients with second line metastatic colorectal cancer. Journal of Clinical Oncology 36, no. 1
Zavodovskaya M, Zhang Y, Xiao Y, Maltzman J, Smith V, Brachmann C, et al. Exploratory Serum Biomarker Analysis in Gastric Cancer Patients Treated with GS-5745, an MMP9 Inhibitor, in Combination with mFOLFOX6 [Abstract 4463/24]. 2017 American Association f
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days | ||
Primary | Percentage of Participants Experiencing Laboratory Abnormalities | Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported. | Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days |
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