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TNFerade biologic

Phase 1

Head and Neck Cancer | Small molecule | Oncology |Precigen, Inc.|Trials Updated: Feb 23, 2012

TNFerade biologic development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Jul 2007

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment -

FDA Designations

No designations recorded

TNFerade biologic clinical trials

TNFerade biologic · 2 trials · 2 indications

Phase 1 2
NCT00496236Radiotherapy, Cetuximab, and Injections of TNFerade™ Biologic for Elderly or Frail Patients With Head and Neck CancerHead and Neck Cancer
COMPLETED- Analytics
NCT00496535A Study of TNFerade™ Biologic With Concomitant Radiotherapy, Fluorouracil, and Hydroxyurea (TNF-FHX) in Patients With Head and Neck CancerHead and Neck Cancer
COMPLETED- Analytics
PHASE1COMPLETED
Radiotherapy, Cetuximab, and Injections of TNFerade™ Biologic for Elderly or Frail Patients With Head and Neck Cancer
Head and Neck CancerUnlock trial analytics
PHASE1COMPLETED
A Study of TNFerade™ Biologic With Concomitant Radiotherapy, Fluorouracil, and Hydroxyurea (TNF-FHX) in Patients With Head and Neck Cancer
Head and Neck CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

The maximum tolerated dose established in the Phase I (dose-finding) portion of the study will be used to assess the investigational drug's ability to enhance clinical outcome. The primary endpoint being locoregional control rate at 24 months.
locoregional control at 24 months

Secondary Endpoints

Locoregional control at 3,6, and 12 months, objective response rate, progression-free survival at 3,6,12, and 24 months, and the rate of distal metastases at 3,6, 12 and 24 months will also be assessed.
Locoregional control at 3, 6 and 12 months, as well as tumor response rate, progression-free survival at 3, 6, 12 and 24 months, and the rate of metastases at 3, 6, 12 and 24 months will also be assessed.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
TNFerade biologicDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Age 70 or older with an ECOG performance status 0-2,or * Patients \> 18 years of age with ECOG performance status of 2 or greater, or * Patients \> 18 years of age unsuitable for concurrent chemotherapy or surgery due to: * Renal failure, or * Severe cardiopulmonary disease, o...

Countries:United States
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Frequently asked questions about TNFerade biologic

What is TNFerade biologic used for?

TNFerade biologic was studied for the treatment of head and neck cancer. It was evaluated in Phase 1 clinical trials in patients with head and neck cancer and head and neck neoplasms, including one study in elderly or frail patients. It is an investigational therapy and is not approved for commercial use.

Who is developing TNFerade biologic?

TNFerade biologic is being developed by Precigen, Inc., which trades under the ticker symbol PGEN. Precigen is the company associated with the clinical development of this investigational head and neck cancer therapy.

What phase is TNFerade biologic in?

TNFerade biologic is in Phase 1 clinical development. Two Phase 1 trials have been conducted, and both are now completed. There are currently no active trials for TNFerade biologic. It remains an investigational agent and has not been approved by the FDA.

What clinical trials is TNFerade biologic in?

TNFerade biologic has been evaluated in two completed Phase 1 trials. NCT00496535 studied TNFerade biologic with concomitant radiotherapy, fluorouracil, and hydroxyurea in patients with head and neck cancer. NCT00496236 studied radiotherapy, cetuximab, and injections of TNFerade biologic in elderly or frail patients with head and neck cancer. Both trials were conducted in the United States.

Is TNFerade biologic FDA approved?

No, TNFerade biologic is not FDA approved. It is an investigational therapy that has completed Phase 1 clinical development for head and neck cancer. Both of its Phase 1 trials are completed, and no active trials are ongoing.