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

NCT00495625 | Terminated Phase 2 Results DMC

• 2 other identifiers: MCC-14733Pfizer #2005-0880
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cancer

Keywords

Hepatocellular cancer (HCC); Sunitinib malate; Vascular endothelial growth factor (VEGF); Platelet-derived growth factor (PDGF); Tyrosine kinases; Liver

Outcome Measures

Primary Outcomes (3)

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

  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 \[JNCI 92(3):205-216, 2000\].

  On Treatment to Off Study - average of 7 months per participant

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

  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 \[JNCI 92(3):205-216, 2000\].

  On Treatment to Off Study - average of 7 months per participant

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

  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 \[JNCI 92(3):205-216, 2000\].

  On Treatment to Off Study - average of 7 months per participant

Secondary Outcomes (3)

• Participant Time to Tumor Progression (TTP)

  On Treatment to Off Study - average of 7 months per participant

• Number of Participants With Overall Survival (OS)

  On Treatment to Off Study - average of 7 months per participant

• Number of Participants With Serious Adverse Events (SAEs)

  On Treatment to Off Study - average of 7 months per participant

Study Arms (1)

Sunitinib Malate (SUO11248) Treatment

EXPERIMENTAL

Drug: Sunitinib Malate

Interventions

Sunitinib Malate DRUG

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.

Also known as: SU011248, Sutent

Sunitinib Malate (SUO11248) Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 grade less than or equal to 1.
• Adequate organ function as defined by the following criteria:
• Serum aspartate transaminase (AST); serum glutamic oxaloacetic transaminase (SGOT) and serum alanine transaminase (ALT); serum glutamic pyruvic transaminase (SGPT) less than or equal to 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy
• Total serum bilirubin less than or equal to 1.5 x ULN
• Absolute neutrophil count (ANC) more than or equal to 1500/mcL
• Platelets more than or equal to 100,000/mcL
• Hemoglobin more than or equal to 9.0 g/dL
• Serum calcium less than or equal to 12.0 mg/dL
• Serum creatinine less than or equal to 1.5 x ULN
• Biopsy-proven disease
• Measurable disease radiographically
• Disease that is deemed surgically unresectable (awaiting orthotopic hepatic transplantation allowable) and/or metastatic
• Age greater or equal to 18 years
• Life expectancy greater than 16 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 (Karnofsky score \> 60%)

You may not qualify if:

• Major surgery or radiation therapy or chemotherapy within 4 weeks of starting the study treatment
• NCI CTCAE version 3 grade 3 hemorrhage within 4 weeks of starting the study treatment
• History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening computed tomography (CT) or magnetic resonance imaging (MRI) scan
• Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
• Known brain metastases
• Ongoing cardiac dysrhythmias of NCI CTCAE grade greater than or equal to 2
• Ongoing cardiac dysrhythmias of NCI CTCAE grade greater than or equal to 2, atrial fibrillation of any grade, or prolongation of the QTc interval to \> 450msec for males or \> 470 msec for females
• Hypertension that cannot be controlled by medications (\>150/100 mm Hg despite optimal medical therapy)
• Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection
• Concurrent treatment on another clinical trial; supportive care trials or non-treatment trials, e.g. Quality of Life (QOL), are allowed
• Concomitant use of ketoconazole or other agents known to induce CYP3A4
• Concomitant use of theophylline and phenobarbital and/or other agents metabolized by the cytochrome P450 system
• Ongoing treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg po daily for thrombo prophylaxis is allowed)
• Pregnancy or breastfeeding. Female subjects must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female subjects with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Pfizer: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

• H Lee Moffitt Cancer Center \& Research Institute website

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

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

Results Point of Contact

• Title: Jonathan Strosberg, M.D.
• Organization: H. Lee Moffitt Cancer Center and Research Institute

jonathan.strosberg@moffitt.org

813-745-7257

Study Officials

• Jonathan Strosberg, MD

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2007
• First Posted: July 3, 2007
• Study Start: October 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 27, 2012
• Results First Posted: March 23, 2012

Record last verified: 2011-12

Locations

US (1)