Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

All Drugs and Chemicals

Antineoplastic Agents

Liver Extracts

Sorafenib

Patients with advanced HCC who have experienced tumor progression with sorafenib will receive ABC294640.

ABC294640 500 mg orally twice daily (approximately 12 hours apart) continuously.

ABC294640 will be dosed under fasting conditions (at least 1 hour before or 2 hours after eating). A cycle is defined as 28 days.

ABC294640

Micheal Lilly, MD

This is a Phase II study of single agent ABC294640. Patients with advanced hepatocellular carcinoma (HCC) who have experienced tumor progression or unacceptable toxicity on single agent sorafenib will receive ABC294640 500 mg by mouth twice a day continuously. Patients will continue on study drug until the development of progressive disease per modified RECIST, intolerable toxicity, withdrawal of patient consent or other event as outlined in patient discontinuation.

A Phase II Study of ABC294640 as Monotherapy in Patients With Advanced Hepatocellular Carcinoma

A Phase II Study of ABC294640 in Patients With Advanced Hepatocellular Carcinoma Who Have Progressed on Sorafenib

Radiographic Assessment will be completed up to 28 days prior to registration and every 8 weeks (+/- 7 days) following registration until disease progression or other (e.g.toxicity, patient decision, etc). The baseline radiographic assessment will include CT or MRI of the chest, abdomen and pelvis. Subsequent imaging will include only those body regions that include measureable index lesions per modified RECIST. Radiographic assessments will be completed every 8 weeks (+/- 7 days). In regards to the end of treatment visit, if the patient is taken off study and already has radiographic documentation of progressive disease, completing the radiographic assessment at the end of treatment visit is not required per study. If the patient is taken off study for other reasons such as toxicity or patient decision, it is strongly recommended that a radiographic assessment be obtained.

Patients who have not progressed by the end of the follow-up will have their TTP values censored.

Survival times will be censored for patients lost to follow-up or still alive at the trial's termination.

Blood samples will be drawn. Plasma or PK analysis for ABC294640 will be collected on:

* Cycle 1 (each cycle is 28 days) Day 1 prior to and at 2 and 8 hours post ABC294640 dosing
* Prior to dosing on and at 2 hours post dose Cycle 1 Day 15
* Prior to dosing on Cycle 2 Day 1.

Scatterplots of percent change in target lesions versus change in marker levels will be constructed. Variable transformations will be considered as needed and Pearson or Spearman correlation coefficients will be constructed as appropriate. The sample size of 39 provides a minimum of 80% power to detect a correlation of at least ± 0.44 versus a null correlation of 0.

All AEs and SAEs whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, laboratory test, or other means will be reported appropriately. Each reported AE or SAE will be described by its duration (i.e., start and end dates), regulatory seriousness criteria if applicable, suspected relationship to the study, and actions taken. Adverse events will be coded by body system and summary of table with incidence rates of AEs will be generated. Severity, duration, investigator attributed relationship to study drug and adverse event outcomes will be reported.

Scatterplots of percent change in target lesions versus change in immune cell subsets will be constructed. Variable transformations will be considered as needed and Pearson or Spearman correlation coefficients will be constructed as appropriated. The sample size of 39 provides a minimum of 80% power to detect a correlation of at least ± 0.44 versus a null correlation of 0.

Spots Global Cancer Trial Database for A Phase II Study of ABC294640 as Monotherapy in Patients With Advanced Hepatocellular Carcinoma

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Study Description

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