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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Fosbretabulin Tromethamine (CA4P) in Combination With Paclitaxel and Carboplatin in Anaplastic Thyroid Carcinoma (FACT2)

Phase 3
18 Years
Not Enrolling
Anaplastic Thyroid Cancer

Thank you

Trial Information

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Fosbretabulin Tromethamine (CA4P) in Combination With Paclitaxel and Carboplatin in Anaplastic Thyroid Carcinoma (FACT2)

The Treatment Plan followed for all subjects will consist of:

- A Screening Visit within 14 days before study drug (fosbretabulin or placebo)

- A Treatment Phase of 21-day combination treatment (study drug plus chemotherapy) cycles
(up to 6 cycles)

- An End of Treatment Phase assessment

- An End of Study Visit occurring 30 days after the last day of study drug
administration, as able

After the last clinic visit, all subjects will be followed for survival by monthly phone
calls, email, or in-person.

Inclusion Criteria:

- Unresectable, residual, recurrent or persistent ATC, histologically or cytologically

- Prior cytotoxic therapeutic regimen as primary therapy for curative intent or prior
targeted therapies (TKIs) are eligible (Prior taxane or platinum therapy is allowed)

- Untreated ATC following biopsy, surgery for curative intent, palliation, or after
radiation therapy has been considered or administered with or without
radiosensitizing chemotherapy

- Disease present on clinical exam (measurable or non-measurable)

- Distant metastases (Stage IVC) only must have histologic confirmation of ATC either
from the original primary lesion or a metastatic site

- Neoadjuvant therapy with radiation and either radiosensitizing chemotherapy followed
by surgery for curative intent, palliation, or biopsy are eligible if residual or
persistent ATC is present

- Subjects with tracheostomy are eligible

- ECOG PS 2 or less

- Adequate bone marrow, renal, and hepatic function, electrolytes WNL for the

Exclusion Criteria:

- Disease that is able to be completely resected with negative microscopic margins and
without any residual disease in the body

- Active brain metastases, including symptomatic involvement, evidence of cerebral
edema by prior CT or MRI, radiographic evidence of brain metastasis since definitive
therapy, or continued requirement for corticosteroids for cerebral edema

- History of malignancies other than ACT except prior lower grade thyroid malignancy,
curatively treated basal cell carcinoma and in-situ melanoma of the skin, cervical
intra-epithelial neoplasia,localized prostate cancer, in-situ carcinoma of the breast

- Known intolerance or hypersensitivity to fosbretabulin, paclitaxel, carboplatin or
any of their components

- Receiving concurrent investigational therapy or have received investigational therapy
for any indication within 28 days of the first scheduled day of dosing

- Grade 3 or greater peripheral neuropathy

- History of prior cerebrovascular event,including transient ischemic attack within the
past 6 months

- Uncontrolled hypertension defined as blood pressure >150/100 mm Hg despite medication

- Symptomatic vascular disease (e.g. intermittent claudication)

- History of unstable angina pectoris pattern, myocardial infarction (including non-Q
wave) within the past 6 months, or NYHA Class III or IV congestive heart failure

- History of torsade de pointes, ventricular tachycardia, ventricular fibrillation or
congenital long QT syndrome.

- Pathologic bradycardia (<60 b/m or heart block(excluding 1st degree block, consisting
of PR interval prolongation only)

- ECG findings of clinically significant ventricular arrhythmia, new ST segment
elevation or depression, or new Q wave on ECG (PVCs are not excluded).

- QTc interval 480 ms or more

- Requirement of concurrent treatment with any drugs know to prolong the QTc interval,
including anti-arrhythmic medications

- Potassium and/or magnesium concentrations below normal range for the reference

- History of solid organ or bone marrow transplant

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

Maximun length of study for each subject is 2 years from date of randomization

Safety Issue:


Principal Investigator

Marcia Brose, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania, Philadelphia, PA 19104


United States: Food and Drug Administration

Study ID:




Start Date:

June 2013

Completion Date:

December 2016

Related Keywords:

  • Anaplastic Thyroid Cancer
  • ATC
  • Anaplastic Thyroid Cancer
  • Stage IVC Anaplastic Thyroid Cancer
  • Thyroid Cancer
  • Head and Neck Tumors
  • Thyroid Neoplasms
  • Thyroid Diseases