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

Completed · Phase 2

Conditions studied: Cholangiocarcinoma

In brief

This research study is studying Dasatinib as a possible treatment for cancer of bile ducts.

Key facts

Study ID

NCT02428855

Run by

Massachusetts General Hospital

People needed

8

Starts

2015-04-01

Expected to finish

2018-02-01

Last updated by the study team

2020-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must meet the following criteria on screening examination to be eligible to participate in the study:
• Participants must have unresectable or metastatic histologically confirmed intrahepatic cholangiocarcinoma
• Patients must have either IDH1 or IDH2 mutations (any known mutations) based on the SNaPshot platform or other molecular testing platform from either archived tissue or fresh biopsy (tested in CLIA-certified lab)
• Patients with other biliary tract cancers (extrahepatic or gallbladder cancers) with IDH1 or IDH2 mutations are allowed
• Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥10 mm with spiral CT scan. See section 10 for the evaluation of measureable disease.
• Participants must have received at least one prior platinum-based regimen for advanced cholangiocarcinoma and had progressive disease or become intolerable to the regimen
• Age ≥18 years.
• Life expectancy of ≥3 months.
• ECOG performance status 0 or 1 (see Appendix A).
• Participants must have adequate organ and marrow function as defined below:
• Absolute neutrophil count ≥ 1,200/mcL
• Platelets ≥75,000/mcL
• Hemoglobin ≥9 g/dL
• Total bilirubin ≤ 2.5 x the upper limit of normal
• AST (SGOT)/ALT (SGPT) ≤ 5 X institutional upper limit of normal
• PT/PTT ≤ 1.5 x ULN
• Creatinine ≤ 1.5 or GFR ≥ 60 mL/min/1.73m2
• Serum Albumin ≥2.8 g/dl
• Prior chemoembolization, radiofrequency ablation, or radiation to the liver is allowed as long as the patient has measurable disease outside of the treated area or measurable progression at the site of the treated area
• Ability to understand and the willingness to sign a written informed consent document.
• Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (eg, male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used. All subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug(s).
• Women of childbearing potential must have a negative pregnancy test at screening. Women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Postmenopause is defined as amenorrhea ≥ 12 consecutive months. Note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other reversible reason.

You may not qualify if…

• 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
• Thromboembolic event requiring therapeutic anticoagulation (Note: subjects with a venous filter (e.g. vena cava filter) are not eligible for this study)
• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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