NCT01803282

Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 236 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Pancreatic Cancer
• Non-small Cell Lung Cancer
• Esophagogastric Cancer
• Colorectal Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Andecaliximab	Administered intravenous infusion
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)

Timeline

• Start date: 2013-03-29
• Primary completion: 2019-04-23
• Completion: 2019-04-23
• First posted: 2013-03-04
• Last updated: 2020-06-02
• Results posted: 2020-05-04

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study