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First in Human Trial of TAS266 in Patients With Advanced 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.
ClinicalTrials.gov Identifier: NCT01529307
Recruitment Status : Terminated
First Posted : February 8, 2012
Last Update Posted : December 12, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will assess safety, tolerability, maximum tolerated dose or recommended dose for expansion of TAS266 administered by IV infusion to patients with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: TAS266 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-label Dose Escalation Study With Safety Expansion of TAS266 Administered by IV Infusion to Patients With Advanced Solid Tumors
Study Start Date : June 2012
Primary Completion Date : September 2012
Study Completion Date : September 2012
Arms and Interventions

Arm Intervention/treatment
Experimental: TAS266 Drug: TAS266
TAS266 IV infusions given weekly


Outcome Measures

Primary Outcome Measures :
  1. Frequency and characteristics of Dose limiting toxicities at each dose level [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Type, frequency, and severity of AEs, changes in laboratory and clinical assessments [ Time Frame: 2 years ]
  2. TAS266 serum concentrations and PK parameters: Cmax, Tmax, AUC0-tlast, Tlast, T1/2 and accumulation ratio of TAS266 [ Time Frame: 8 timepoints each for Cycles 1 and 2, prior to dosing on Day 1 of Cycles 3, 4, 5 and 6, at End of Treatment ]
    1 Treatment Cycle = 28 days,) assuming maximum 6 cycles of treatment

  3. Presence and concentration of anti-TAS266 antibodies [ Time Frame: 2 Years ]
  4. Tumor response [ Time Frame: 2 Years ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Confirmed diagnosis of solid tumors
  • 18 years or older
  • ECOG performance status of 0, 1 or 2
  • Adequate bone marrow, hepatic and renal function
  • Obtained written informed consent

Exclusion Criteria:

  • Patients with primary CNS tumor or CNS tumor involvement. However patients with CNS metastases may be allowed if certain conditions are met.
  • Major surgery within 4 weeks before study treatment
  • Prior anaphylactic or other severe infusion reactions to human immunoglobulin or antibody formulations
  • Impaired cardiac functions
  • Previous hepatitis viral infection such as hepatitis B or hepatitis C
  • Diagnosis of HIV infection
  • Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01529307


Locations
United States, Florida
H. Lee Moffitt Cancer Center/University of South Florida Moffitt SC
Tampa, Florida, United States, 33612
United States, Texas
South Texas Accelerated Research Therapeutics START
San Antonio, Texas, United States, 789229
United States, Utah
University of Utah / Huntsman Cancer Institute Huntsman UT
Salt Lake City, Utah, United States, 84103
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01529307     History of Changes
Other Study ID Numbers: CTAS266X2101
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: December 12, 2012
Last Verified: December 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Biologic,
solid tumors,
Death Receptor 5 agonist,
caspase-8