Status:
COMPLETED
Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors
Lead Sponsor:
Gilead Sciences
Conditions:
Pancreatic Cancer
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
March 29 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2019
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT01803282
Start Date
March 29 2013
End Date
April 23 2019
Last Update
June 2 2020
Active Locations (18)
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1
Alabama Oncology
Birmingham, Alabama, United States, 35243
2
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States, 85258
3
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
4
San Diego Pacific Oncology and Hematology Associates, Inc.
Encinitas, California, United States, 92024