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OpenTrials
Completed

NCT Number: NCT01803282

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Andecaliximab

Drug

Administered intravenous infusion

Other names: GS-5745

Gemcitabine

Drug

Administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle

Nab-paclitaxel

Drug

Administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle

carboplatin

Drug

Administered intravenously on Day 1 of each 21-day treatment cycle

Pemetrexed

Drug

Administered intravenously on Day 1 of each 21-day treatment cycle

Leucovorin

Drug

Administered intravenously on Days 1 and 15 of each 28-day treatment cycle

Oxaliplatin

Drug

Administered intravenously on Days 1 and 15 of each 28-day treatment cycle

5-FU

Drug

Administered intravenously on Days 1 and 15 of each 28-day treatment cycle

Bevacizumab

Drug

Administered intravenously on Days 1 and 15 of each 28-day treatment cycle

Irinotecan

Drug

Administered intravenously on Days 1 and 15 of each 28-day treatment cycle

paclitaxel

Drug

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)

Primary outcomes

  1. Percentage of Participants Experiencing Treatment-Emergent Adverse Events

    Time frame: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days

  2. Percentage of Participants Experiencing Laboratory Abnormalities

    Time frame: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days

    Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Mar 4, 2013
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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