Trial 3L-10-2

Ph II-105, Study of MK-2206 in Patients with Advanced Hepatocellular Carcinoma Who Have Failed or are Intolerant of One Prior Line of Anti-Angiogenic Therapy.

Type: Cancer Therapy
Phase: Phase II
Status: Closed to Accrual with Ongoing Follow-up
Treatments: Chemotherapy: Systemic
Randomized: No
Defintions of terms and FAQ about clinical trials.

Trial Leaders/Researchers: Anthony El-Khoueiry, M.D.
Other Trial Staff: Ramona Lujan, R.N., Jiayi Jiang, D.M., Noureddine Miloud, D.M.

Staff may log in to see study documents.

You may participate in this study if:

	Requirement
1	Unresectable or metastatic HCC for which standard curative measures do not exist
2	Measurable disease that has not been the target of local or regional therapy, including transarterial chemoembolization, intra-arterial chemotherapy, ethanol or RFA ablation
3	One prior line of systemic anti-angiogenic therapy, including, but not restricted to sorafenib, bevacizumab, sunitinib, or brivanib given as single agents or in combination with other agents. Any number of prior regional therapies with transarterial chemoembolization, intra-arterial chemotherapy or ablative therapy is allowed.
4	At least 18 years of age
5	Life expectancy of greater than 3 months
6	ECOG performance status 0-1
7	WBC = / > 3.0; AGC = / > 1.0; platelets = / > 70,000
8	Total bilirubin < / = 1.5 x uln; SGOT/SGPT < 5 x uln
9	Creatinine wnl or CrCl = / > 60 ml/min for patients with creatinine levels > nl
10	Albumin = / > 2.8 gm/dl
11	Patients with hepatitis B infection (positive HBsAg) should be on suppressive anti-viral therapy. Only the following anti-viral therapies are allowed while a patient is on study - Tenofovir disoproxil fumarate and entecavir.
12	Must agree to collection of correlative blood samples during the study
13	Signed an approved study-specific informed consent and HIPAA

You may not participate in this study if:

1	Prior anti-angiogenic therapy, chemotherapy, RT, or regional therapy (such as transarterial chemoembolization, intra-arterial chemotherapy) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from AEs due to agents administered > 4 weeks earlier. Localized radiation for palliation (i.e., bone metastasis, etc) given for < 3 days is allowed before therapy and is not subject to the 4 week waiting requirement. Local ablative therapy such as radiofrequency ablation or cryotherapy must have been completed > 2 weeks prior to study entry.
2	Receiving any other investigational or non-investigational agents directed at treating their hepatocellular carcinoma. Patients may not be receiving any other investigational agents for any condition.
3	Known brain metastases
4	History of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-2206 or other agents used in the study
5	Receiving any medications or substances that are inhibitors or inducers of CYP3A4
6	HgbA1C levels = / > 8% or FBS = / > 150 mg/dl. Patients with DM or at risk for hyperglycemia must have hyperglycemia well controlled on oral agents before entering trial.
7	Baseline QTcF > 450 msec (male) or QTcF > 470 msec (female)
8	Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic CHF, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
9	Pregnant or nursing women. Women of childbearing potential and men must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the patient should inform the treating physician immediately.
10	HIV-positive patients on combination anti-retroviral therapy
11	Patients with hypothyroidism must be on a stable dose of thyroid replacement and be clinically euthyroid
12	Clinically evident ascites (minimal, medically controlled ascites detectable on imaging studies only is allowed)
13	Child-Pugh C cirrhosis or Child-Pugh B cirrhosis with > 7 points
14	Fibrolamellar carcinoma or any mixed variants of HCC with dominant fibrolamellar histology
15	Esophageal or gastric variceal bleeding within the last 6 months
16	Unable to swallow pills or diagnosed with a GI disorder that are likely to interfere with the absorption of MK-2206 or with the patient’s ability to take regular oral medication
17	Second primary cancer, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors including lymphomas without BM involvement curatively treated with no evidence of disease for = / > 5 years
18	Symptomatic CHF, unstable angina, clinically significant and uncontrolled cardiac dysrhythmia, uncontrolled HTN (systolic BP > 150 or diastolic BP > 100 on two occasions within two weeks of beginning therapy on this protocol), MI within 6 months, NYHA class > II, clinically significant bradycardia related to underlying cardiac disease, clinically significant BBB related to underlying cardiac disease
19	Received more than one prior line of systemic therapy for advanced/unresectable disease. Any number of prior regional therapies with transarterial chemoembolization, intra-arterial chemotherapy, or ablative therapy is allowed.

For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or clinical.trials@med.usc.edu.

To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.