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

Anaplastic Thyroid Cancer Clinical Trial

— FACT2  

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01701349
• Other study ID #: OX4317s
• Status: Withdrawn
• Phase: Phase 3
• First received: October 2, 2012
• Last updated: April 30, 2014
• Start date: March 2015
• Est. completion date: December 2017

Study information

• Verified date: April 2014
• Source: OXiGENE
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The Treatment Plan followed for all subjects will consist of:

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

• 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Unresectable, residual, recurrent or persistent ATC, histologically or cytologically confirmed

• 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 laboratory

• History of solid organ or bone marrow transplant

Study Design

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

Related Conditions & MeSH terms

• Anaplastic Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• Fosbretabulin + paclitaxel + carboplatin
Fosbretabulin 200 mg/m2 IV infusion
• Placebo + paclitaxel + carboplatin
Paclitaxel 200 mg/m2, Carboplatin AUC 6 IV infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
OXiGENE

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Determine the proportion of subjects with measurable disease who have objective tumor response, by treatment		Maximun length of study for each subject is 2 years from date of randomization	No
Primary	Overall survival		Maximun length of study for each subject is 2 years from date of randomization	No
Secondary	Number of adverse events of the combination of fosbretabulin + paclitaxel + carboplatin		Maximun length of study for each subject is 2 years from date of randomization	Yes
Secondary	Number of participants with 1-year survival		Maximun length of study for each subject is 2 years from date of randomization	No

External Links

•   Corporate website
•   Thyroid Cancer Survivors' Association, Inc.