A Multi-center, Open-label Study of Oral ENMD-2076 for the Treatment of Patients With Advanced Fi… (NCT02234986) | Clinical Trial Compass
CompletedPhase 2
A Multi-center, Open-label Study of Oral ENMD-2076 for the Treatment of Patients With Advanced Fibrolamellar Carcinoma
United States35 participantsStarted 2015-10
Plain-language summary
The purpose of the study is to determine whether once-daily dosing with ENMD-2076 will be a safe and effective treatment in patients with FLC. Safety will be measured by looking at the adverse events that may happen and the efficacy will look at the progression of the disease over time.
Who can participate
Age range12 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically or cytologically confirmed advanced fibrolamellar carcinoma (FLC).
* All forms of prior local therapy are allowed as long as patients have either a target lesion, which has not been treated with local therapy and/or the target lesion(s) within the field of the local-regional therapy has shown an increase of ≥ 20% in size. Local-regional therapy must be completed at least 4 weeks prior to the baseline CT scan. Local therapies including chemoembolization do not count as prior systemic therapy.
* Are at least 4 weeks from major surgery and recovered.
* At least one measureable lesion by RECIST 1.1.
* Male or non-pregnant, non-breastfeeding female at least 18 years of age. Patients aged at 12\~18 years may be recruited but only at the site principle investigator's request and subject to Institutional Review Board (IRB) approval.
* Has a pre-study echocardiogram or multi-gated acquisition (MUGA) scan with an actual left ventricular ejection fraction of greater than or equal to the institutional lower limit of normal within one month of initiating therapy.
* Have clinically acceptable laboratory screening results within certain limits specified below:
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 times upper limit of normal (ULN)
* Total bilirubin ≤ 3.0 x ULN
* Creatinine ≤ 1.5 x ULN or Cr Cl \> 60 cc/min
* Absolute neutrophil count ≥ 1500 cells/mm3
* Platelets ≥ 50,000/mm3
* Have an Eastern Cooperative On…