Anaplastic Thyroid CancerPhase 3FACT2NCT01701349
Fosbretabulin or Placebo in Combination With Carboplatin/Paclitaxel in Anaplastic Thyroid Cancer
A Phase 3 study testing Fosbretabulin + paclitaxel + carboplatin in people with Anaplastic Thyroid Cancer, run by Mateon Therapeutics.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaplastic Thyroid Cancer
- What is being tested?
- Fosbretabulin + paclitaxel + carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Subjects with tracheostomy are eligible
- ECOG PS 2 or less
- Adequate bone marrow, renal, and hepatic function, electrolytes WNL for the institution
Who cannot join
- 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
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- 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
About this study
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)
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.
Read the 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.
- Conditions
- Anaplastic Thyroid Cancer
- Being tested
- Fosbretabulin + paclitaxel + carboplatin, Placebo + paclitaxel + carboplatin
- Keywords
- ATC, Anaplastic Thyroid Cancer, Stage IVC Anaplastic Thyroid Cancer, Thyroid Cancer, Head and Neck Tumors
- Medical subject headings
- Thyroid Carcinoma, Anaplastic, Thyroid Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosbretabulin + paclitaxel + carboplatinDrug
Also called Fosbretabulin, Combretastatin, Zybrestat, CA4P
Fosbretabulin 200 mg/m2 IV infusion
Placebo + paclitaxel + carboplatinDrug
Also called Paclitaxel, Carboplatin
Paclitaxel 200 mg/m2, Carboplatin AUC 6 IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Fosbretabulin + paclitaxel + carboplatin | Active comparator | 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 Receives: Drug: Fosbretabulin + paclitaxel + carboplatin |
| Placebo + paclitaxel + carboplatin | Placebo comparator | 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 Receives: Drug: Placebo + paclitaxel + carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: Maximun length of study for each subject is 2 years from date of randomization
Secondary outcomes (2)
Number of adverse events of the combination of fosbretabulin + paclitaxel + carboplatin
Measured: Maximun length of study for each subject is 2 years from date of randomization
Number of participants with 1-year survival
Measured: Maximun length of study for each subject is 2 years from date of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startMar 2015
- Primary completionApr 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Expected inability to recruit study participants in a reasonable amount of time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaplastic Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mateon Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcia Brose, MD, PhD, Principal investigator, University of Pennsylvania, Philadelphia, PA 19104Julie A Sosa, MD, Principal investigator, Yale University, New Haven, CT 06520Lisa Licitra, MD, Principal investigator, Instituto Nazionale Per Lo Studio E La Cura Dei Tumori, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701349
- Sponsor's protocol ID
- OX4317s
- Acronym
- FACT2
- Status last verified
- Apr 2014
- First submitted
- 2 Oct 2012
- Last updated
- 1 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01701349
- Acronym / sponsor ID
- FACT2 / OX4317s
- Conditions
- Anaplastic Thyroid Cancer
- Keywords
- ATC, Anaplastic Thyroid Cancer, Stage IVC Anaplastic Thyroid Cancer, Thyroid Cancer, Head and Neck Tumors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Expected inability to recruit study participants in a reasonable amount of time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mateon TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 5 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fosbretabulin + paclitaxel + carboplatin | Active comparator | Drug: Fosbretabulin + paclitaxel + carboplatinSix 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 |
| Placebo + paclitaxel + carboplatin | Placebo comparator | Drug: Placebo + paclitaxel + carboplatinSix 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fosbretabulin + paclitaxel + carboplatinAlso: Fosbretabulin, Combretastatin, Zybrestat, CA4PFosbretabulin 200 mg/m2 IV infusion | Drug | Fosbretabulin + paclitaxel + carboplatin |
| Placebo + paclitaxel + carboplatinAlso: Paclitaxel, CarboplatinPaclitaxel 200 mg/m2, Carboplatin AUC 6 IV infusion | Drug | Placebo + paclitaxel + carboplatin |
Primary outcome
Overall survival
Time frame: Maximun length of study for each subject is 2 years from date of randomization
2 secondary outcomes
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
Number of participants with 1-year survival
Time frame: Maximun length of study for each subject is 2 years from date of randomization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2014.
- Thyroid Cancer Survivors' Association, Inc.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcia Brose, MD, PhD principal investigator
University of Pennsylvania, Philadelphia, PA 19104
Julie A Sosa, MD principal investigator
Yale University, New Haven, CT 06520
Lisa Licitra, MD principal investigator
Instituto Nazionale Per Lo Studio E La Cura Dei Tumori, Milan, Italy
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fosbretabulin + paclitaxel + carboplatin in people with Anaplastic Thyroid Cancer, run by Mateon Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 May 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Maximun length of study for each subject is 2 years from date of randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2014.