Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors
Public ClinicalTrials.gov record NCT01803282. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01803282
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 236 participants
Conditions and interventions
Conditions
Interventions
- Andecaliximab Drug
- Gemcitabine Drug
- Nab-paclitaxel Drug
- Carboplatin Drug
- Pemetrexed Drug
- Leucovorin Drug
- Oxaliplatin Drug
- 5-FU Drug
- Bevacizumab Drug
- Irinotecan Drug
- Paclitaxel Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 29, 2013 (Actual)
- Primary completion
- Apr 23, 2019 (Actual)
- Completion
- Apr 23, 2019 (Actual)
- Last update posted
- Jun 2, 2020
2013 – 2019
United States locations
- U.S. sites
- 18
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Oncology | Birmingham | Alabama | 35243 | — |
| Pinnacle Oncology Hematology | Scottsdale | Arizona | 85258 | — |
| Comprehensive Blood and Cancer Center | Bakersfield | California | 93309 | — |
| San Diego Pacific Oncology and Hematology Associates, Inc. | Encinitas | California | 92024 | — |
| University of Southern California (USC) | Los Angeles | California | 90033 | — |
| California Pacific Medical Center | San Francisco | California | 94115 | — |
| UCLA Medical Center | Santa Monica | California | 90404 | — |
| Florida Cancer Specialists | Sarasota | Florida | 34232 | — |
| Parkview Research Center | Fort Wayne | Indiana | 46845 | — |
| Indiana University Health Goshen Center for Cancer Care | Goshen | Indiana | 46526 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Cornell University | New York | New York | 10021 | — |
| Greenville Health System, Institute for Translational Oncology Research | Greenville | South Carolina | 29605 | — |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Vanderbilt | Nashville | Tennessee | 37232 | — |
| UT Southwestern | Dallas | Texas | 75390 | — |
| University of Utah | Salt Lake City | Utah | 84112 | — |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01803282, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 2, 2020 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01803282 live on ClinicalTrials.gov.