Neoplasms

Digestive System Diseases

All Conditions

Carcinoma, Hepatocellular

Liver Neoplasms

Carcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Hematinics

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Liver Extracts

Endothelial Growth Factors

Mitogens

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles will be 37.5 mg daily for 28 days, every 42 days. Dose may be escalated to 50 mg daily for 28 days at the treating investigator's discretion.

Sunitinib Malate

Jonathan Strosberg, MD

An open label multi-site phase II clinical trial of dose escalated sunitinib malate given orally once daily on days 1-28 of each 42-day cycle. Treatment will be continued until there is either disease progression or cumulative or acute toxicity which in the opinion of the treating physician compromises the ability of the patient to receive treatment or patient desire to stop treatment.

An open label multi-site phase II clinical trial of sunitinib malate given orally once daily on days 1-28 of each 42-day cycle. Sunitinib malate will be dispensed as capsules at the beginning of each treatment cycle. The dose may be escalated at the investigator's discretion. Treatment will be continued until there is either disease progression or cumulative or acute toxicity which in the opinion of the treating physician compromises the ability of the patient to receive treatment or patient desire to stop treatment.

A follow up visit will be required before the beginning of every cycle every 6 weeks to assess toxicity and for physical examination. Complete blood count (CBC) and differential, comprehensive metabolic panel (including liver function tests) and alpha-feto protein (when indicated) will be obtained at every scheduled follow up visit.

Sunitinib Malate (SUO11248) In Subjects W/ Metastatic And/Or Surgically Unresectable Hepatocellular Cancers (HCC)

Phase II Open-Label Study of Sunitinib Malate (SUO11248) in Adult Subjects With Metastatic and/or Surgically Unresectable Hepatocellular Cancers (HCC)

Partial Response at Interim Analysis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (unidimensional measurement) of target lesions, taking as reference the baseline sum longest diameter (LD). Response was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\].

Stable Disease (SD) Rate at Interim Analysis. Stable Disease (SD): Neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum longest diameter (LD) since the treatment started. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\].

Progressive Disease Rate. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\].

Investigators planned to determine the time to tumor progression (TTP) of sunitinib malate in the treatment in unresectable Hepatocellular Cancers (HCC). TTP is defined as the duration of time from start of treatment to time of progression.

Overall survival (OS) of sunitinib malate in the treatment in unresectable HCC

The toxicity of sunitinib malate in the treatment in unresectable HCC

Pfizer

H. Lee Moffitt Cancer Center and Research Institute

First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10

Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.

Sunitinib Malate (SUO11248) Treatment

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

The Principal Investigator who initiated the study left Moffitt before reaching the target enrollment required to perform the planned analysis.

Jonathan Strosberg, M.D.

17 of the 23 patients that were enrolled at time of Interim Analysis (patients enrolled between 10/13/06 and 9/24/07) were evaluable for response.

Number of Participants With Partial Response (PR) at Interim Analysis

Not analyzed. The Principal Investigator who initiated the study left Moffitt before reaching the target enrollment required to perform the planned analysis.

Participant Time to Tumor Progression (TTP)

Participants who had not expired on their off study date.

Number of Participants With Overall Survival (OS)

Number of Participants With Serious Adverse Events (SAEs)

Number of Participants With Stable Disease (SD) at Interim Analysis

Number of Participants With Progressive Disease (PD) at Interim Analysis

Overall Study

Pharmaceutical Solutions

Lipid Regulating Agents

Cholestyramine Resin

U3-1784 (2.5 mg/kg) by intravenous infusion, along with colestyramine or equivalent if clinically indicated

U3-1784 (3.75 mg/kg) by intravenous infusion, along with colestyramine or equivalent if clinically indicated

U3-1784 (5.6 mg/kg) by intravenous infusion, along with colestyramine or equivalent if clinically indicated

Solution for solution in 5% dextrose for infusion, intravenously administered every 2 weeks (q2w) as a 250 mL IV, along with colestyramine or equivalent if clinically indicated

U3-1784

Alberto Martinez, PhD

The main objectives of the trial are:

* To evaluate the safety and tolerability of U3-1784 in patients with advanced solid tumours
* To determine the maximum tolerated dose (MTD) and or establish the safety and tolerability of the maximum administered dose (MAD) of U3-1784

An Open Study Assessing the Safety and Tolerability of U3-1784

A Phase 1, Open-label, Two-part, Safety and Tolerability Study of U3-1784 in Patients With Advanced Solid Tumours

Treatment emergent adverse events (TEAEs) are systematically collected - clinically significant changes in laboratory values are recorded as TEAEs in system organ class: Investigations

Daiichi Sankyo

Nivolumab

Immunomodulating Agents

Relatlimab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants receive Nivolumab and Relatlimab.

Nivolumab 480mg will be administered as a 30 minute IV infusion (-/+15min) at cycle 1 day 1 and at cycle 2 day 1 (28 days) then every month for up to 12 months. Intravenous administration of Nivolumab (480 mg) will occur on Cycle 1 and 2 of the study then every 28 days up to a year. Nivolumab will be administered on Day 1 of each cycle for 10 doses/ months (whichever occurs first) for adjuvant.

Patients will receive 480 mg Relatlimab intravenously (-/+15min) on cycle 1 day 1 and at cycle 2 day 1 (every 28 days) for up to 1 year co-administered with Nivolumab.

Colleen Apostal, RN

Joann Santmyer, RN

Bradley Wilt, RN

Trish Brothers, RN

Mark Yarchoan, MD

Barbara Kleiber, MACPR, BSN, RN, OCN, CCRC

Aslam Ejaz, MD

The purpose of this study is to determine the safety and tolerability of neoadjuvant/adjuvant Nivolumab or Nivolumab plus Relatlimab in patients with HCC.

Feasibility and Efficacy of Perioperative Nivolumab With or Without Relatlimab for Patients With Potentially Resectable Hepatocellular Carcinoma (HCC)

Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0.

ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.

OS will be measured from date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.

Number of months from the date of first treatment until disease recurrence at 12 months. Estimation based on the Kaplan-Meier curve.

Number of months from the date of first treatment until disease recurrence at 18 months. Estimation based on the Kaplan-Meier curve.

Number of months from the date of first treatment until disease recurrence at 3 years. Estimation based on the Kaplan-Meier curve.

Number of months from the date of first treatment until disease recurrence at 5 years. Estimation based on the Kaplan-Meier curve.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sunitinib Malate (SUO11248) In Subjects W/ Metastatic And/Or Surgically Unresectable Hepatocellular Cancers (HCC)	NCT00495625	Liver Cancer	Sunitinib Malat...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
An Open Study Assessing the Safety and Tolerability of U3-1784	NCT02690350	Advanced Solid ... Hepatocellular ...	U3-1784	18 Years -	Daiichi Sankyo
Sunitinib Malate (SUO11248) In Subjects W/ Metastatic And/Or Surgically Unresectable Hepatocellular Cancers (HCC)	NCT00495625	Liver Cancer	Sunitinib Malat...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Sunitinib Malate (SUO11248) In Subjects W/ Metastatic And/Or Surgically Unresectable Hepatocellular Cancers (HCC)	NCT00495625	Liver Cancer	Sunitinib Malat...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Feasibility and Efficacy of Perioperative Nivolumab With or Without Relatlimab for Patients With Potentially Resectable Hepatocellular Carcinoma (HCC)	NCT04658147	Hepatocellular ...	Nivolumab Relatlimab	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
An Open Study Assessing the Safety and Tolerability of U3-1784	NCT02690350	Advanced Solid ... Hepatocellular ...	U3-1784	18 Years -	Daiichi Sankyo

Spots Global Cancer Trial Database for hepatocellular cancer (hcc)