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A Study of ALT-836 in Combination With Gemcitabine for Locally Advanced or Metastatic Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01325558
Recruitment Status : Completed
First Posted : March 30, 2011
Last Update Posted : July 15, 2016
Information provided by (Responsible Party):
Altor BioScience

Brief 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.

Condition or disease Intervention/treatment Phase
Locally Advanced Malignant Neoplasm Malignant Solid Tumour Biological: ALT-836 in combination with gemcitabine Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Multi-center, Competitive Enrollment and Dose-escalation Study of ALT-836 in Combination With Gemcitabine for Locally Advanced or Metastatic Solid Tumors
Study Start Date : May 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : February 2015

Intervention Details:
  • Biological: ALT-836 in combination with gemcitabine
    Study participants will receive up to four courses of a 28-day biochemotherapy with the study drug (ALT-836) and gemcitabine. Each treatment course consists of five doses of ALT-836 (on Day 1, 4, 8, 15 and 22) and three doses of gemcitabine (Day 1, 8 and 15). Participants with persistent responses will receive additional two cycles, three doses each, of standard of care gemcitabine therapy.

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of ALT-836 in combination with gemcitabine [ Time Frame: 18 months ]
  2. Safety Profile [ Time Frame: 18 months ]
    Number and severity of treatment related AEs that occur or worsen after the first dose of study treatment

  3. Clinical Benefit [ Time Frame: 18 months ]
    Number of participants with complete response, partial response or stable disease

  4. Progression Free Survival [ Time Frame: 36 months ]
    Number of participants with 9-month, 12-month, 18-month, 24-month, 30-month or 36-month progression-free survival

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 36 months ]
    Number of participants with 9-month, 12-month, 18-month, 24-month, 30-month or 36-month overall survival

  2. Pharmacokinetics [ Time Frame: 18 months ]
    Area under the plasma concentration-time curve from time zero to infinity (AUC) and the half-life of ALT-836

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed
  • Locally advanced or metastatic non-hematologic malignancies
  • Measureable
  • Refractory to standard therapies or single agent gemcitabine is indicated as a standard treatment option


  • No concurrent radiotherapy, chemotherapy, immunotherapy or other investigational agents
  • Must have recovered from side effects of prior therapies


Life expectancy

  • > 12 weeks

Performance Status

  • ECOG 0 or 1

Bone Marrow Reserve

  • Absolute Neutrophil count (AGC/ANC) ≥ 1,500/uL
  • Platelets ≥ 100,000/uL
  • Hemoglobin > 9 g/dL

Renal Function

  • Calculated Glomerular filtration rate (GFR) > 59mL/min/1.73M^2

Hepatic Function

  • Total bilirubin ≤ 1.5 X ULN
  • AST, ALT, and ALP ≤ 3 X ULN or ≤ 5.0 x ULN, if liver metastasis exists
  • PT INR ≤ 1.5 X ULN


  • No history of clinically significant vascular disease
  • No New York Heart Association (NYHA) Class > II heart failure


  • No history of bleeding disorders
  • No evidence of bleeding diathesis or coagulopathy
  • No presence of clinically significant hemoptysis or hematuria, presence of serious non-healing wound or ulceration, or signs of other bleeding
  • No evidence of a tumor invasion of any major blood vessel
  • No trauma with increased risk of life-threatening bleeding or history of severe head trauma or intracranial surgery within two months of study entry


  • No major surgery or open biopsy within 28 days before drug infusion or evidence of active bleeding postoperatively
  • No plan for any major surgery during treatment period
  • No presence or requirement of an epidural catheter or lumbar puncture within 48 hours prior to each dose of study treatment
  • No anticipation of receiving an epidural catheter or a lumbar puncture within 48 hours after each dose of study treatment

Excluded Medications or Treatment Regimens

  • Unfractionated heparin of > 15,000 units/day within 8 hours prior to each dose of study treatment
  • Low-molecular weight heparin at a higher dose than recommended for prophylactic used or required within 20 hours prior to each dose of study treatment
  • Warfarin used or required within 48 hours prior to each dose of study treatment and the prothrombin time (INR) exceeded the upper limit of normal range
  • Direct thrombin inhibitors or Xa inhibitors
  • Acetylsalicylic acid used or required within 72 hours prior to each dose of study treatment
  • Clopidogrel bisulfate used or required within 48 hours prior to each dose of study treatment
  • Anticipated requirement for anti-platelet or anti-coagulant agents excluding non-aspirin NSAID within 48 hours following study treatment infusion


  • No active systemic infection requiring parenteral antibiotic therapy
  • No history of or presence of a CNS disease
  • No history of allergic reactions to compounds of similar chemical or biologic composition
  • Not HIV positive
  • No women who are pregnant or nursing
  • A negative serum pregnancy test if female
  • Patients, both females and males, with reproductive potential must agree to use effective contraceptive measures for the duration of the study
  • No history of significant renal, endocrinologic, metabolic, immunologic or hepatic disease
  • No evidence of psychiatric illness/social situations
  • Other illness that in the opinion of the investigator would exclude the patient from participating
  • Must provide informed consent and HIPAA authorization and comply with protocol-specified procedures and follow-up evaluations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01325558

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United States, Georgia
Emory University, Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, New York
University of Rochester Medical Center, James P. Wilmot Cancer Center
Rochester, New York, United States, 14642
United States, North Carolina
Carolinas Hematology-Oncology Associates
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
Altor BioScience
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Responsible Party: Altor BioScience Identifier: NCT01325558    
Other Study ID Numbers: CA-ALT-836-02-10
First Posted: March 30, 2011    Key Record Dates
Last Update Posted: July 15, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Altor BioScience:
tissue factor
solid tumor
ovarian cancer
breast cancer
non-small cell lung cancer
colon cancer
pancreatic cancer
head and neck cancer
prostate cancer
soft-tissue sarcoma
venous thromboembolism
Additional relevant MeSH terms:
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Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs