Trametinib in Combination With Paclitaxel in the Treatment of Anaplastic Thyroid Cancer (NCT03085056) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Trametinib in Combination With Paclitaxel in the Treatment of Anaplastic Thyroid Cancer
United States13 participantsStarted 2017-03-15
Plain-language summary
The purpose of this study is to test the safety and tolerability of this treatment combination of paclitaxel and trametinib. Additionally, this study aims to to find out what effects the combination of paclitaxel and trametinib has on the shrinkage and growth of anaplastic thyroid cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pathologically (histologically or cytologically) proven diagnosis of anaplastic thyroid cancer (a diagnosis that is noted to be consistent with anaplastic thyroid cancer is acceptable).
* Metastatic disease or local-regional disease that is considered not resectable for cure.
* Patients must have measurable disease per RECIST v1.1 criteria, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam
* Age ≥18 years
* ECOG performance status ≤2 (or Karnofsky ≥60)
* Able to swallow and retain orally-administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption, such as malabsorption syndrome or major resection of the stomach or bowels
* No CTCAE v4 grade \>2 neuropathy
* Patients must have normal organ and marrow function as defined below:
* Absolute neutrophil count (ANC) ≥1.5x10\^9/L
* Hemoglobin ≥9 g/dL
* Platelets ≥100x10\^9/L
* Serum bilirubin ≤1.5x institutional upper limit of normal (ULN) (Unless Gilbert's Disease in which case total bilirubin ≤3x institutional ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x institutional ULN (≤5x institutional ULN if there is liver metastasis)
* Serum creatinine ≤1.5 mg/dL OR calculate…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.