First in Human Trial of TAS266 in Patients With Advanced Solid Tumors

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01529307
First received: February 1, 2012
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Advanced Solid Tumors
Drug: TAS266
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Frequency and characteristics of Dose limiting toxicities at each dose level [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Type, frequency, and severity of AEs, changes in laboratory and clinical assessments [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
    1 Treatment Cycle = 28 days,) assuming maximum 6 cycles of treatment

  • Presence and concentration of anti-TAS266 antibodies [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
  • Tumor response [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: June 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAS266 Drug: TAS266
TAS266 IV infusions given weekly

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01529307     History of Changes
Other Study ID Numbers: CTAS266X2101
Study First Received: February 1, 2012
Last Updated: December 10, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014