First in Human Trial of TAS266 in Patients With Advanced Solid Tumors
This study has been terminated.
Sponsor:
Novartis Pharmaceuticals
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
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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
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 May 22, 2013