Carcinoma, HepatocellularPhase 2NCT02939807
A Phase II Study of ABC294640 as Monotherapy in Patients With Advanced Hepatocellular Carcinoma
A Phase 2 study testing ABC294640 in people with Carcinoma, Hepatocellular, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- ABC294640
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to 30 Jan 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have advanced hepatocellular carcinoma; fibrolamellar HCC is not allowed. Hepatocellular carcinoma will be confirmed by at least one of the following:
- Tissue diagnosis
- The presence of one or more liver lesions measuring 2 cm in longest diameter, showing characteristic arterial enhancement and venous washout using arterial-phase contrast enhanced imaging, and a clinical history of cirrhosis.(1)
- Voluntary signed and dated institutional review board (IRB) approved informed consent form in accordance with regulatory and institutional guidelines.
- Documented progression or intolerance to sorafenib as determined by the enrolling investigator:
- Patient must have at least one measurable untreated lesion as per modified RECIST criteria. Measurable disease may include extrahepatic lesions. Abdominal imaging should employ a "liver protocol" image capture technique. The following are not considered measurable lesions: bone lesions, ascites, and pleural effusions. Prior RFA, PEI, or TACE of non-target lesions is allowed.
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- Time interval for last local therapy (radiofrequency ablation, percutaneous ethanol injection, radiotherapy, transarterial chemoembolization) more than 4 weeks prior to registration.
- Life expectancy of at least 12 weeks.
- 18 years of age or older.
- ECOG performance status of 0-2.
- Child-Pugh Cirrhotic Status A or B with a score of 7.
- Acceptable liver function:
- Bilirubin ≤ 3 times upper limit of normal (CTCAE Grade 2 baseline)
- AST (SGOT), ALT (SGPT) 3 x ULN (CTCAE Grade 1 baseline)
- Acceptable kidney function:
- Serum creatinine ≤ 1.5 XULN (CTCAE Grade 1 baseline)
- Acceptable hematologic status:
- Absolute neutrophil count 1000 cells/mm3
- Platelet count 75,000 (plt/mm3), (CTCAE Grade 1 baseline)
- Hemoglobin 9 g/dL.
- Acceptable blood sugar control
- Fasting glucose < 160 mg/dL (CTCAE grade 1 baseline)
- Urinalysis: No clinically significant abnormalities.
- INR < 1.7
- As determined by the treating investigator, the patient must have well-controlled blood pressure, defined as systolic blood pressure <150mmHg and/or diastolic blood pressure <100 mmHg for the majority of measurements.
- A negative pregnancy test (only for WOCBP).
- Willingness to use effective contraceptive methods during the study. If patient is female (or female partner of male subject), must be either not of childbearing potential (defined as postmenopausal for ≥ 1 year or surgically sterile) or is practicing two forms of contraception. Sexually active male participants must agree to use a physical barrier method (male latex rubber condom with or without spermicide).
Who cannot join
- New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG.
- Underlying psychiatric disorder requiring hospitalization within the last two years or a HADS score of 11 or more.
- Clinically significant neurological disorder (Parkinson's disease, dementia, multiple sclerosis), as determined by the enrolling investigator
- Active, uncontrolled bacterial, viral or fungal infection, requiring systemic therapy.
- Pregnant or nursing women. NOTE: Women of childbearing potential and men must agree to use adequate contraception or abstinence prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Treatment with radiation therapy, surgery, or investigational therapy within one month prior to registration.
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- More than two lines of prior systemic therapy for HCC
- Unwillingness or inability to comply with procedures required in this protocol.
- Known infection with HIV.
- Hepatitis C on protease therapy.
- Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the Investigator.
- Patients who are receiving drugs that are sensitive substrates of CYP450 1A2, 3A4, 2C9, 2C19 or 2D6, or strong inhibitors or inducers of all major CYP450 isozymes that cannot be stopped at least 7 days or 5 half-lives (whichever is longer) before starting treatment with ABC294640 and either replaced with another appropriate medication or not given for the duration of the clinical study. (A list of commonly used drugs that are sensitive substrates of CYP450 1A2, 3A4, 2C9, 2C19 or 2D6, or strong inhibitors or inducers of all major CYP450 isozymes with the half-life of each drug identified, is included as an Appendix C)
- A history of CTC Grade 3 bleeding esophageal or gastric varices within the past 2 months. Prior variceal bleed is permitted if patient has undergone banding or sclerotherapy and there has been no evidence of bleeding for 2 months. Patients at risk for varices (based on the following: known history of esophageal or gastric varices; evidence of hepatic cirrhosis and/or portal hypertension including biopsy-proven cirrhosis, hypersplenism, or radiographic findings of varices) will be screened (using either esophagogastroduodenoscopy (EGD) or capsule endoscopy) for esophageal varices, unless such screening has been performed in the past two years from study entry and the patient is receiving medical treatment for prophylaxis of variceal bleeding, such as non-selective beta blockade. If varices are identified that require intervention (banding), patient will not be eligible until varices are adequately treated. Patients presenting with gastric varices will not be eligible for the study.
- Patients who are currently taking Coumadin or Coumadin derivatives.
- Patients who are currently participating in any other clinical trial of an investigational product.
- History of organ transplantation.
- Other primary malignancy within past 5 years except carcinoma in situ of the cervix or urinary bladder or non-melanoma skin cancer.
- Any other mental incapacitation or psychiatric illness that would preclude study participation, as determined by the enrolling investigator.
- Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A Phase II Study of ABC294640 in Patients With Advanced Hepatocellular Carcinoma Who Have Progressed on Sorafenib
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.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- ABC294640
- Keywords
- Yeliva™, hepatocellular carcinoma, ABC294640, hepatic neoplasms, liver neoplasms, hepatic cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABC294640Drug
Also called YelivaTM
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.
| Study group | Role | What they receive |
|---|---|---|
| advanced HCC, tumor progression with sorafenib | Experimental | Patients with advanced HCC who have experienced tumor progression with sorafenib will receive ABC294640. Receives: Drug: ABC294640 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess objective response rate (per modified RECIST) of single agent ABC294640 in treatment of HCC
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.
Measured: 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.
Secondary outcomes (12)
To estimate the time to tumor progression (TTP) in HCC patients treated with ABC294640
Patients who have not progressed by the end of the follow-up will have their TTP values censored.
Measured: 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
To estimate the overall survival (OS) in HCC patients treated with ABC294640
Survival times will be censored for patients lost to follow-up or still alive at the trial's termination.
Measured: 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.
To evaluate the pharmacokinetic behavior of ABC294640 in HCC patients [Peak Plasma Concentration (Cmax)]
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.
Measured: From Cycle 1 Day 1 through to prior to dosing in Cycle 2 Day 1. (Each cycle is 28 days)
To evaluate the pharmacokinetic behavior of ABC294640 in HCC patients [Area Under the drug concentration over time curve, (AUC)]
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.
Measured: From Cycle 1 Day 1 through to prior to dosing in Cycle 2 Day 1. (Each cycle is 28 days)
To describe the relationship between changes in marker levels of sphingolipids in peripheral blood in patients being given ABC294640
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.
Measured: 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.
To explore the relationship between changes in c-Myc marker levels in peripheral blood mononuclear cells in patients being given ABC294640
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.
Measured: Peripheral Blood Mononuclear Cells (PBMC) for c-Myc will be collected within 1 hour prior to the pre- and post-treatment biopsies.
To assess the relationship between changes in marker levels of sphingolipids in tumor tissue from patients being given ABC294640.
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.
Measured: 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).
To assess the relationship between changes in c-myc marker levels in tumor tissue from patients being given ABC294640.
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.
Measured: 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).]
Descriptive statistics of adverse events reported in all subjects treated with ABC294640
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.
Measured: 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.
Descriptive statistics of adverse events reported in subjects who discontinued study drug due to adverse events
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.
Measured: 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.
Descriptive statistics of adverse events reported in subjects with adverse events related to study drug.
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.
Measured: 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.
To assess the relationship between changes in immune cell subsets in peripheral blood from subjects being given ABC294640
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study start30 Sep 2019
- Primary completion30 Sep 2023
- Study completion30 Jan 2024
Why it stopped: study is being rewritten for different disease population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Apogee Biotechnology Corporation
- Responsible party
- Sponsor
- Investigators
- Micheal Lilly, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939807
- Sponsor's protocol ID
- 102418
- Other IDs
- ABC-106, 1P01CA203628-01
- Status last verified
- Apr 2025
- First submitted
- 12 Oct 2016
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of ABC294640 in Patients With Advanced Hepatocellular Carcinoma Who Have Progressed on Sorafenib
- ClinicalTrials.gov ID
- NCT02939807
- Acronym / sponsor ID
- 102418
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Yeliva™, hepatocellular carcinoma, ABC294640, hepatic neoplasms, liver neoplasms, hepatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study is being rewritten for different disease population
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Apogee Biotechnology Corporation
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| advanced HCC, tumor progression with sorafenib | Experimental | Drug: ABC294640Patients with advanced HCC who have experienced tumor progression with sorafenib will receive ABC294640. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Patient must have advanced hepatocellular carcinoma; fibrolamellar HCC is not allowed. Hepatocellular carcinoma will be confirmed by at least one of the following:
- Voluntary signed and dated institutional review board (IRB) approved informed consent form in accordance with regulatory and institutional guidelines.
- Documented progression or intolerance to sorafenib as determined by the enrolling investigator:
- Patient must have at least one measurable untreated lesion as per modified RECIST criteria. Measurable disease may include extrahepatic lesions. Abdominal imaging should employ a "liver protocol" image capture technique. The following are not considered measurable lesions: bone lesions, ascites, and pleural effusions. Prior RFA, PEI, or TACE of non-target lesions is allowed.
- Time interval for last local therapy (radiofrequency ablation, percutaneous ethanol injection, radiotherapy, transarterial chemoembolization) more than 4 weeks prior to registration.
Key exclusion criteria (19 listed)
- New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG.
- Underlying psychiatric disorder requiring hospitalization within the last two years or a HADS score of 11 or more.
- Clinically significant neurological disorder (Parkinson's disease, dementia, multiple sclerosis), as determined by the enrolling investigator
- Active, uncontrolled bacterial, viral or fungal infection, requiring systemic therapy.
- Pregnant or nursing women. NOTE: Women of childbearing potential and men must agree to use adequate contraception or abstinence prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABC294640Also: YelivaTMABC294640 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. | Drug | advanced HCC, tumor progression with sorafenib |
Primary outcome
To assess objective response rate (per modified RECIST) of single agent ABC294640 in treatment of HCC
Time frame: 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.
12 secondary outcomes
To estimate the time to tumor progression (TTP) in HCC patients treated with ABC294640
Time frame: 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
To estimate the overall survival (OS) in HCC patients treated with ABC294640
Time frame: 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.
To evaluate the pharmacokinetic behavior of ABC294640 in HCC patients [Peak Plasma Concentration (Cmax)]
Time frame: From Cycle 1 Day 1 through to prior to dosing in Cycle 2 Day 1. (Each cycle is 28 days)
To evaluate the pharmacokinetic behavior of ABC294640 in HCC patients [Area Under the drug concentration over time curve, (AUC)]
Time frame: From Cycle 1 Day 1 through to prior to dosing in Cycle 2 Day 1. (Each cycle is 28 days)
To describe the relationship between changes in marker levels of sphingolipids in peripheral blood in patients being given ABC294640
Time frame: 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.
To explore the relationship between changes in c-Myc marker levels in peripheral blood mononuclear cells in patients being given ABC294640
Time frame: Peripheral Blood Mononuclear Cells (PBMC) for c-Myc will be collected within 1 hour prior to the pre- and post-treatment biopsies.
To assess the relationship between changes in marker levels of sphingolipids in tumor tissue from patients being given ABC294640.
Time frame: 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).
To assess the relationship between changes in c-myc marker levels in tumor tissue from patients being given ABC294640.
Time frame: 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).]
Descriptive statistics of adverse events reported in all subjects treated with ABC294640
Time frame: 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.
Descriptive statistics of adverse events reported in subjects who discontinued study drug due to adverse events
Time frame: 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.
Descriptive statistics of adverse events reported in subjects with adverse events related to study drug.
Time frame: 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.
To assess the relationship between changes in immune cell subsets in peripheral blood from subjects being given ABC294640
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Micheal Lilly, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABC294640 in people with Carcinoma, Hepatocellular, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess objective response rate (per modified RECIST) of single agent ABC294640 in treatment of HCC (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.