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

April 30, 2014 updated by: Mateon Therapeutics

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)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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:
  • Zybrestat
  • CA4P
  • Fosbretabulin
  • Combretastatin
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:
  • Carboplatin
  • Paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Maximun length of study for each subject is 2 years from date of randomization
Maximun length of study for each subject is 2 years from date of randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Maximun length of study for each subject is 2 years from date of randomization
Number of participants with 1-year survival
Time Frame: Maximun length of study for each subject is 2 years from date of randomization
Maximun length of study for each subject is 2 years from date of randomization

Other Outcome Measures

Outcome Measure
Time Frame
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
Maximun length of study for each subject is 2 years from date of randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mateon Therapeutics

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 2, 2012

First Submitted That Met QC Criteria

October 3, 2012

First Posted (Estimate)

October 5, 2012

Study Record Updates

Last Update Posted (Estimate)

May 1, 2014

Last Update Submitted That Met QC Criteria

April 30, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OX4317s

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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