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A Phase I, Open-label Dose Escalation Study With Safety Expansion of TAS266 Administered by IV Infusion to Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

Thank you

Trial Information

A Phase I, Open-label Dose Escalation Study With Safety Expansion of TAS266 Administered by IV Infusion to Patients With Advanced Solid Tumors


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and characteristics of Dose limiting toxicities at each dose level

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CTAS266X2101

NCT ID:

NCT01529307

Start Date:

June 2012

Completion Date:

September 2012

Related Keywords:

  • Advanced Solid Tumors
  • Biologic,
  • solid tumors,
  • Death Receptor 5 agonist,
  • caspase-8
  • Neoplasms

Name

Location

H. Lee Moffitt Cancer Center/University of South Florida Moffitt SCTampa, Florida  33612
University of Utah / Huntsman Cancer Institute Huntsman UTSalt Lake City, Utah  84103
South Texas Accelerated Research Therapeutics STARTSan Antonio, Texas  789229