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Fosbretabulin or Placebo in Combination With Carboplatin/Paclitaxel in Anaplastic Thyroid Cancer (FACT2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01701349
Recruitment Status : Withdrawn (Expected inability to recruit study participants in a reasonable amount of time.)
First Posted : October 5, 2012
Last Update Posted : May 1, 2014
Information provided by (Responsible Party):
Mateon Therapeutics

Brief 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.

Condition or disease Intervention/treatment Phase
Anaplastic Thyroid Cancer Drug: Fosbretabulin + paclitaxel + carboplatin Drug: Placebo + paclitaxel + carboplatin Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Active Comparator: Fosbretabulin + paclitaxel + carboplatin

Six 21 day cycles of:

Fosbretabulin (60 mg/m2) IV on Day 1, 8, 15 Paclitaxel (200 mg/m2) IV on Day 2 Carboplatin (AUC 6) IV on Day 2

Drug: Fosbretabulin + paclitaxel + carboplatin
Fosbretabulin 200 mg/m2 IV infusion
Other Names:
  • Fosbretabulin
  • Combretastatin
  • Zybrestat
  • CA4P

Placebo Comparator: Placebo + paclitaxel + carboplatin

Six 21-day cycles of:

Placebo (formulated and packages to match fosbretabulin)on Day 1, 8, 15 Paclitaxel (200 mg/m2) IV on Day 2 Carboplatin (AUC6) IV on Day 2

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

Primary Outcome Measures :
  1. Overall survival [ Time Frame: Maximun length of study for each subject is 2 years from date of randomization ]

Secondary Outcome Measures :
  1. Number of adverse events of the combination of fosbretabulin + paclitaxel + carboplatin [ Time Frame: Maximun length of study for each subject is 2 years from date of randomization ]
  2. Number of participants with 1-year survival [ Time Frame: Maximun length of study for each subject is 2 years from date of randomization ]

Other Outcome Measures:
  1. Determine the proportion of subjects with measurable disease who have objective tumor response, by treatment [ Time Frame: Maximun length of study for each subject is 2 years from date of randomization ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01701349

Sponsors and Collaborators
Mateon Therapeutics
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Principal Investigator: Marcia Brose, MD, PhD University of Pennsylvania, Philadelphia, PA 19104
Principal Investigator: Julie A Sosa, MD Yale University, New Haven, CT 06520
Principal Investigator: Lisa Licitra, MD Instituto Nazionale Per Lo Studio E La Cura Dei Tumori, Milan, Italy
Additional Information:
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Responsible Party: Mateon Therapeutics Identifier: NCT01701349    
Other Study ID Numbers: OX4317s
First Posted: October 5, 2012    Key Record Dates
Last Update Posted: May 1, 2014
Last Verified: April 2014
Keywords provided by Mateon Therapeutics:
Anaplastic Thyroid Cancer
Stage IVC Anaplastic Thyroid Cancer
Thyroid Cancer
Head and Neck Tumors
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Carcinoma, Anaplastic
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action