Safety and Tolerability Study in Solid Tumors
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Lung Cancer, Colorectal Cancer, Colorectal Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/20/2019 |
| Start Date: | March 29, 2013 |
| End Date: | April 2019 |
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
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.
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.
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.
We found this trial at
18
sites
Santa Monica, California 90404
Principal Investigator: Zev Wainberg, MD
Phone: 310-633-8400
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University of Utah Research is a major component in the life of the U benefiting...
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Bakersfield, California 93309
Principal Investigator: Ravindranath Patel, MD
Phone: 661-862-7122
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Encinitas, California 92024
Principal Investigator: Alberto Bessudo, MD
Phone: 760-452-3909
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Fort Wayne, Indiana 46805
Principal Investigator: Alexander Starodub, MD
Phone: 260-425-6822
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Goshen, Indiana 46526
Principal Investigator: Daniel Bruetman, MD
Phone: 574-364-2359
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Greenville, South Carolina 29605
Principal Investigator: Ki Chung, MD
Phone: 864-455-3735
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Los Angeles, California 90007
Principal Investigator: Heinz-Josef Lenz, MD
Phone: 323-865-0061
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3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Johanna Bendell, MD
Phone: 615-329-7469
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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New York, New York 10021
Principal Investigator: Manish Shah, MD
Phone: 646-962-9344
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Haeseong Park, MD
Phone: 314-362-8246
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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45 Castro Street
San Francisco, California 94114
San Francisco, California 94114
(415) 600-6000
Principal Investigator: Ari Baron, MD
Phone: 415-600-5766
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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Sarasota, Florida 34232
Principal Investigator: Manish Patel, MD
Phone: 941-377-9993
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Scottsdale, Arizona 85258
Principal Investigator: Michael Gordon, MD
Phone: 480-882-0123
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Tacoma, Washington 98405
Principal Investigator: Jorge Chaves, MD
Phone: 253-428-8738
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