Phase II Trial of Dasatinib in Patients With Isocitrate Dehydrogenase (IDH)-Mutant Advanced Intrahepatic Cholangiocarcinoma

Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.

Prior treatment with dasatinib

Periampullary tumors

Chemotherapy, within 4 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin) or those who have not recovered to less than or equal to grade 1 from adverse events due to agents administered more than 4 weeks earlier.

The subject has received radiation therapy:

* to bone or brain metastasis within 14 days of the first dose of study treatment

* to any other site(s) within 28 days of the first dose of study treatment

The subject has active brain metastases or epidural disease (Note: Subjects with brain metastases previously treated with whole brain radiation or radiosurgery or subjects with epidural disease previously treated with radiation or surgery who are asymptomatic and do not require steroid treatment for at least 2 weeks before starting study treatment are eligible. Neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment. (Baseline brain imaging with contrast-enhanced CT or MRI scans for subjects with known brain metastases is required to confirm eligibility.)

The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:

* Cardiovascular disorders including

* Congestive heart failure (CHF): New York Heart Association (NYHA) Class III (moderate) or Class IV (severe) at the time of screening

* Concurrent uncontrolled hypertension defined as sustained BP \> 140 mm Hg systolic, or \> 90 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment

* Diagnosed or suspected congenital long QT syndrome

* Any of the following within 6 months before the first dose of study treatment:

* Unstable angina pectoris

* Clinically-significant cardiac arrhythmias

* Stroke (including TIA, or other ischemic event)

* Myocardial infarction

* Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)

* Prolonged QTc interval on pre-entry electrocardiogram (\> 450 msec), may use either the Fridericia and Bazett's correction

* Hypokalemia or hypomagnesemia that is not corrected prior to dasatinib administration

* Patients should not be taking drugs that are generally accepted to have a risk of causing Torsades de Pointes. The following must be discontinued at least 7 days prior to starting dasatinib to be eligible:quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide,dofetilide, erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine,levomethadyl, pentamidine, sparfloxacin, lidoflazine

* Other clinically significant disorders such as:

* active infection requiring systemic treatment within 28 days before the first dose of study treatment

* serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment

* Patients with known moderate/severe pleural effusions that are unrelated to malignancy or established diagnosis of pulmonary arterial hypertension

Concurrent malignancy (other than adequately treated non-melanoma skin cancer, superficial transitional cell carcinoma of the bladder, and cervical carcinoma in situ) diagnosed within the past 3 years or any currently active malignancy

Psychiatric illness/social situations that would limit compliance with study requirements.

The subject has received any other type of investigational agent within 28 days before the first dose of study treatment.

The subject is unable to swallow tablets

Individuals who are known to be HIV-positive are excluded from this study.

Pregnant women are excluded from this study due to the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with dasatinib, breastfeeding should be discontinued if the mother is treated with dasatinib. These potential risks may also apply to other agents used in this study.

Subjects may not be receiving any other study agents concurrently while on this study

Phase II Trial of Dasatinib in Patients With Isocitrate Dehydrogenase (IDH)-Mutant Advanced Intrahepatic Cholangiocarcinoma

What this study is about

Phase II Trial of Dasatinib in Patients With Isocitrate Dehydrogenase (IDH)-Mutant Advanced Intrahepatic Cholangiocarcinoma

What this study is about