Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 13 of 13

List	Outcome	Time frame	Description
Primary	To assess objective response rate (per modified RECIST) of single agent ABC294640 in treatment of HCC	The primary endpoint is objective response rate (ORR) at 16 weeks defined according to modified RECIST criteria in second-line ABC294640 in patients with advanced HCC 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.
Secondary	To estimate the time to tumor progression (TTP) in HCC patients treated with ABC294640	While on study, radiographic response will be documented every 8 weeks; after discontinuation, every 3 months for a maximum of 24 months after the last patient registered	Patients who have not progressed by the end of the follow-up will have their TTP values censored.
Secondary	To estimate the overall survival (OS) in HCC patients treated with ABC294640	Time interval from initiation of study treatment to death due to any cause. All patients should be followed every 3 months for survival for a maximum of 24 months after the last patient has been registered to the trial.	Survival times will be censored for patients lost to follow-up or still alive at the trial's termination.
Secondary	To evaluate the pharmacokinetic behavior of ABC294640 in HCC patients [Peak Plasma Concentration (Cmax)]	From Cycle 1 Day 1 through to prior to dosing in Cycle 2 Day 1. (Each cycle is 28 days)	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.
Secondary	To evaluate the pharmacokinetic behavior of ABC294640 in HCC patients [Area Under the drug concentration over time curve, (AUC)]	From Cycle 1 Day 1 through to prior to dosing in Cycle 2 Day 1. (Each cycle is 28 days)	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.
Secondary	To describe the relationship between changes in marker levels of sphingolipids in peripheral blood in patients being given ABC294640	Plasma samples for sphingolipid profiling will be drawn at baseline, on Cycle 1 Day 1 prior to and 8 hours post ABC dosing, and prior to dosing on Cycle 1 Day 15 and Cycle 2 Day 1, and within 1 hour prior to the pre- and post-treatment tumor biopsies.	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.
Secondary	To explore the relationship between changes in c-Myc marker levels in peripheral blood mononuclear cells in patients being given ABC294640	Peripheral Blood Mononuclear Cells (PBMC) for c-Myc will be collected within 1 hour prior to the pre- and post-treatment biopsies.	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.
Secondary	To assess the relationship between changes in marker levels of sphingolipids in tumor tissue from patients being given ABC294640.	Tumor biopsies will be obtained within 28 days prior to Cycle 1 (each cycle is 28 days) Day 1, and again on Cycle 2 Day 1 (+/- 7 days), and will be assessed for tumor sphingolipid profile and tumor signaling proteins (c-Myc, pAKT, SK2).	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.
Secondary	To assess the relationship between changes in c-myc marker levels in tumor tissue from patients being given ABC294640.	Tumor biopsies will be obtained within 28 days prior to Cycle 1 (each cycle is 28 days) Day 1, and again on Cycle 2 Day 1 (+/- 7 days), and will be assessed for tumor sphingolipid profile and tumor signaling proteins (c-Myc, pAKT, SK2).]	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.
Secondary	Descriptive statistics of adverse events reported in all subjects treated with ABC294640	The study period during which all AEs and SAEs must be reported begins after initiation of study treatment and ends 30 days following the last administration of study treatment.	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.
Secondary	Descriptive statistics of adverse events reported in subjects who discontinued study drug due to adverse events	The study period during which all AEs and SAEs must be reported begins after initiation of study treatment and ends 30 days following the last administration of study treatment.	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.
Secondary	Descriptive statistics of adverse events reported in subjects with adverse events related to study drug.	The study period during which all AEs and SAEs must be reported begins after initiation of study treatment and ends 30 days following the last administration of study treatment.	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.
Secondary	To assess the relationship between changes in immune cell subsets in peripheral blood from subjects being given ABC294640	Blood will be drawn at baseline, on Cycle 1 Day 1 prior to and 8 hours post ABC294640 dosing, prior to dosing on Cycle 1 Day 15 and Cycle 2 Day 1, and within 1 hour prior to the pre-and post-treatment tumor biopsies.	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.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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