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

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Blood and Lymph Conditions

Immune System Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Lung Neoplasms

Syndrome

Leukemia

Mastocytosis

Gastrointestinal Stromal Tumors

Hypersensitivity

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Mastocytosis, Systemic

Hypereosinophilic Syndrome

Dermatofibrosarcoma

Hematologic Diseases

Myeloproliferative Disorders

Myelodysplastic-Myeloproliferative Diseases

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Mast Cell Activation Disorders

Eosinophilia

Leukocyte Disorders

Fibrosarcoma

Neoplasms, Fibrous Tissue

Sarcoma

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Systemic Mastocytosis

Dermatofibrosarcoma Protuberans

Chronic Myeloproliferative Disorders

Myelodysplastic/myeloproliferative Disease

Soft Tissue Sarcoma

Imatinib Mesylate

Tyrosine Kinase Inhibitors

imatinib mesylate

Novartis Pharmaceuticals

This trial is for various types of malignancies which may depend on certain enzymes (tyrosine kinases) for growth. The objective of this study is to assess to what extent imatinib mesylate blocks these enzymes and to assess the effect on the malignancy.

Condition

Diverse malignancies either associated with or thought to be associated with activated tyrosine kinase enzymes including hypereosinophilic syndrome systemic mastocytosis chronic myelomonocytic leukaemia, dermatofibrosarcoma protuberans and other diseases.

Not included:

Patients with chronic myeloid leukemia, some other types of leukemias (abl-mutated) some types of gastrointestinal stromal tumours (c-KIT-positive), some systemic mastocytosis (if c-KIT D816V mutation), brain, prostate, breast or lung cancers.

Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes

MP 412

Solid oral dosage; 4 dosage strengths; 25, 50, 100, or 200 mg per capsule Dosing Frequency: Once daily dosing for 4 weeks (4 weeks equals 1 cycle)

AV-412

Manuel Hidalgo, MD, PhD

Justina L Martinez, MD

Carmen S. Puparelli, MD

Belén R. Viquiera, M.D.

AV-412 is a new oral therapy developed to inhibit the growth of solid tumors in patients who have not responded to standard therapy or surgical interventions, or who have experienced relapse. This study will test the safety of AV-412 and determine the maximum tolerated dose for the treatment of solid tumors.

Although progress has been made, patients with malignancies often either progress after the traditional approach of chemotherapy, surgery, or radiotherapy, or are not candidates for these approaches because of the advances stage of disease. Novel therapies that may offer greater potential than those currently available are urgently needed.

AV 412 is a potent inhibitor of human epidermal growth factor family receptor tyrosine kinases (TKIs) and represents a growing class of anti-cancer agents. The recent introduction of TKIs has opened the door to new approaches to cancer treatment in which the goals of therapy are to halt disease progression, ameliorate symptoms, and improve patient quality of life. AV412 may inhibit growth of solid tumors, with fewer and less debilitating side effects.

This study is designed to determine the safety, tolerability and maximum tolerated dose of daily oral administration of AV 412. Patients will be assigned to escalating drug dose cohorts to determine the optimal dose. Evaluations to determine tolerability include PK, PD, and the adverse events which occur during the course of study drug administration.

Safety/Tolerability Study of AV-412 in Subjects With Refractory or Relapsed Solid Tumor Malignancies

A Phase 1, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of Daily Oral Administration of AV-412 in Patients With Refractory or Relapsed Solid Tumor Malignancies

AVEO Pharmaceuticals, Inc.

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
Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes	NCT00171912	Hypereosinophil... Systemic Mastoc... Chronic Myelomo... Dermatofibrosar...	imatinib mesyla...	16 Years - 80 Years	Novartis
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
Safety/Tolerability Study of AV-412 in Subjects With Refractory or Relapsed Solid Tumor Malignancies	NCT00381654	Tumor	AV-412	18 Years -	AVEO Pharmaceuticals, Inc.

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