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Fosbretabulin or Placebo in Combination With Carboplatin/Paclitaxel in Anaplastic Thyroid Cancer

Information source: OXiGENE
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anaplastic Thyroid Cancer

Intervention: Fosbretabulin + paclitaxel + carboplatin (Drug); Placebo + paclitaxel + carboplatin (Drug)

Phase: Phase 3

Status: Withdrawn

Sponsored by: OXiGENE

Official(s) and/or principal investigator(s):
Marcia Brose, MD, PhD, Principal Investigator, Affiliation: University of Pennsylvania, Philadelphia, PA 19104
Julie A Sosa, MD, Principal Investigator, Affiliation: Yale University, New Haven, CT 06520
Lisa Licitra, MD, Principal Investigator, Affiliation: Instituto Nazionale Per Lo Studio E La Cura Dei Tumori, Milan, Italy


This is a multicenter, double-blind, placebo-controlled, randomized study of fosbretabulin given with chemotherapy (paclitaxel and carboplatin) compared to placebo given with chemotherapy (paclitaxel and carboplatin) in subjects with anaplastic thyroid cancer (ATC). The primary objective of the study is to determine overall survival. A maximum of 300 subjects will be recruited from approximately 75 multinational sites of which approximately 35 will be located in the United States.

Clinical Details

Official title: 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)

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

Primary outcome: Overall survival

Secondary outcome:

Number of adverse events of the combination of fosbretabulin + paclitaxel + carboplatin

Number of participants with 1-year survival

Detailed description: 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

institution 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

Locations and Contacts

Additional Information

Corporate website

Thyroid Cancer Survivors' Association, Inc.

Starting date: March 2015
Last updated: April 30, 2014

Page last updated: August 23, 2015

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