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

February 1, 2012
December 10, 2012
June 2012
September 2012   (final data collection date for primary outcome measure)
Frequency and characteristics of Dose limiting toxicities at each dose level [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01529307 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
First in Human Trial of TAS266 in Patients With Advanced Solid Tumors
A Phase I, Open-label Dose Escalation Study With Safety Expansion of TAS266 Administered by IV Infusion to Patients With Advanced Solid Tumors

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Tumors
Drug: TAS266
TAS266 IV infusions given weekly
Experimental: TAS266
Intervention: Drug: TAS266
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
September 2012
September 2012   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01529307
CTAS266X2101
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP