Clinical Trials Logo

Clinical Trial Summary

This is a Phase I, open-label, multi-center, competitive enrollment and dose-escalation study of ALT-836 in combination with standard of care gemcitabine in participants who have locally advanced or metastatic solid tumors. The purpose of this study is to determine the maximum tolerated dose (MTD), and to assess the safety and pharmacokinetic profile of ALT-836 given with gemcitabine. The clinical benefit, progression-free survival and overall survival of study participants will also be assessed.


Clinical Trial Description

Tissue Factor (TF) is over-expressed in most cancer types. Results from many recent studies have suggested a key role for TF in the development of cancer-associated thrombosis, tumor growth, tumor angiogenesis, and tumor metastasis. ALT-836, a recombinant human-chimeric monoclonal antibody, is designed as a direct TF antagonist to block TF displayed by cancers and to inhibit cancer-associated venous thromboembolism, tumor growth, tumor angiogenesis and tumor metastasis. In numerous pre-clinical studies in laboratory animals, including non-human primates, ALT-836 exhibits potent anti-tumor, anti-thrombotic and anti-inflammatory activities with a remarkable safety profile. In humans, ALT-836, administered as a single bolus and monotherapy in patients with coronary artery disease (CAD) and acute lung injury/acute respiratory distress syndrome (ALI/ARDS), is safe and exhibits anti-coagulant and anti-inflammatory effects. A Phase II study using a multi-dose regimen of ALT-836 is being conducted in patients with ALI/ARDS. In the dose-escalation study described in this protocol, the investigators will assess the safety and determine the maximum tolerated dose (MTD) of ALT-836 in combination with gemcitabine in patients with advanced malignancies known to overexpress TF and in which venous thromboembolism is a major complication. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01325558
Study type Interventional
Source Altor Bioscience Corporation
Contact
Status Completed
Phase Phase 1
Start date May 2011
Completion date February 2015

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03671226 - Preference of Room Setting and Waiting Time in Patients With Advanced, Locally Advanced, or Metastatic Cancer and Their Caregivers Who Are Seen in the Outpatient Supportive/Palliative Care Center N/A
Completed NCT01973673 - Healthy Bones Study N/A
Completed NCT01876927 - Pre-Operative Or Peri-Operative Dox Regimen In Patients With Locally Advanced Resectable Gastric Cancer Phase 2
Terminated NCT03295942 - A Study of OMP-336B11 in Subjects With Locally Advanced or Metastatic Tumors Phase 1
Completed NCT03238027 - A Phase 1 Study to Investigate Axatilimab Alone or in Combination With Durvalumab in Patients With Solid Tumors Phase 1
Recruiting NCT04260802 - A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers Phase 1/Phase 2
Completed NCT02823652 - Pre-Test Genetic Education and Remote Genetic Counseling in Communicating Tumor Profiling Results to Patients With Advanced Cancer N/A
Completed NCT02227082 - Olaparib and Radiotherapy in Inoperable Breast Cancer Phase 1
Recruiting NCT01871363 - Phase II Study of Preoperative IMRT Combined With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer Phase 2
Completed NCT01847001 - Study of Propranolol in Newly Diagnosed Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy Phase 2
Terminated NCT03170115 - Induction Chemotherapy Plus Chemoradiotherapy With or Without Aspirin in High Risk Rectal Cancer Phase 2
Recruiting NCT04749108 - Study Evaluating the Tailored Management of Locally-advanced Rectal Carcinoma Phase 2/Phase 3
Terminated NCT01836432 - Immunotherapy Study in Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer Phase 3
Recruiting NCT01675999 - Trial of Neoadjuvant Chemotherapy in Locally Advanced Colon Cancer Phase 2
Completed NCT01333709 - Multicenter Phase 2 Trial: a Tailored Strategy for Locally Advanced Rectal Carcinoma Phase 2
Withdrawn NCT03849742 - Ride to Care - Quality of Life With Transportation for RT N/A
Active, not recruiting NCT03856060 - Videos and Questionnaires in Assessing Patient Perception of Physician's Compassion, Communication Skills, and Professionalism During Clinic Visits N/A
Completed NCT04186884 - Caregiver Burden, Quality of Life, and Symptom Distress at Different Palliative Cancer Care Settings
Recruiting NCT04112836 - Pancreatic Cancer Malnutrition and Pancreatic Exocrine Insufficiency in the Course of Chemotherapy in Unresectable Pancreatic Cancer
Not yet recruiting NCT03051152 - D1 Versus D2 Lymphadenectomy in High Risk Elderly With Gastric Adenocarcinoma N/A