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A Phase I Study Of SU006668 Via Twice Daily Oral Administration Under Fed Conditions In Patients With Advanced Malignancies

Phase 1
18 Years
Open (Enrolling)
Breast Cancer, Colorectal Cancer, Gastric Cancer, Kidney Cancer, Lung Cancer, Multiple Myeloma and Plasma Cell Neoplasm, Pancreatic Cancer, Prostate Cancer

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Trial Information

A Phase I Study Of SU006668 Via Twice Daily Oral Administration Under Fed Conditions In Patients With Advanced Malignancies

OBJECTIVES: I. Determine the maximum tolerated dose of SU006668 in patients with advanced
solid tumors. II. Determine the pharmacokinetics of this drug in these patients. III.
Determine the objective response of patients treated with this drug. IV. Determine the toxic
effects of this drug in these patients.

OUTLINE: This is a dose-escalation study. Patients receive oral SU006668 twice daily.
Treatment repeats every 28 days in the absence of disease progression or unacceptable
toxicity. Cohorts of 6 to 12 patients receive escalating doses of SU006668 until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which
at least 2 of 6 or 4 of 12 patients experience dose-limiting toxicity. Patients are followed
at 30 days and then every 3 months thereafter.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Diagnosis of one of the following advanced malignancies: Breast
Colorectal Non-small cell lung Gastric Pancreatic Renal Prostate Myeloma Failed standard
therapy OR No effective standard therapy exists Measurable or evaluable disease No known
CNS metastases Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Male or female Menopausal status: Not
specified Performance status: Karnofsky 60-100% Life expectancy: Not specified
Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL AST
and ALT no greater than 3 times upper limit of normal Renal: Creatinine no greater than 2
mg/dL OR Creatinine clearance at least 40 mL/min Cardiovascular: No myocardial infarction
or severe/unstable angina within the past 6 months No evidence of uncompensated coronary
artery disease by electrocardiogram or physical exam Other: No other malignancy within the
past 5 years except basal cell skin cancer or carcinoma in situ of the cervix No
insulin-dependent diabetes mellitus No non-insulin-dependent diabetes mellitus with
clinical evidence of severe peripheral vascular disease or diabetic ulcers No
manifestation of malabsorption due to prior surgery, GI disease, or unknown reasons No
active inflammatory bowel disease No known intolerance to any excipients in the study drug
formulation No other acute or chronic medical or psychiatric condition or laboratory
abnormality that would preclude study Not pregnant or nursing Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior anticancer
biologic or immunotherapy and recovered No prior SU006668 No other concurrent
immunotherapy Chemotherapy: At least 4 weeks since prior anticancer chemotherapy (6 weeks
for nitrosoureas or mitomycin) and recovered No concurrent chemotherapy Endocrine therapy:
At least 4 weeks since prior hormonal therapy No concurrent hormonal therapy except for
hormonal contraception or appetite stimulation Radiotherapy: Recovered from prior
radiotherapy Surgery: At least 6 weeks since prior surgery At least 6 months since prior
coronary/peripheral artery bypass graft surgery Prior major GI surgery allowed if no
residual syptomatic manifestation of malabsorption No prior organ transplantation Other:
At least 4 weeks since prior investigational agents No other concurrent investigational

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Lee S. Rosen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Breast Cancer
  • Colorectal Cancer
  • Gastric Cancer
  • Kidney Cancer
  • Lung Cancer
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Pancreatic Cancer
  • Prostate Cancer
  • stage III colon cancer
  • stage IV colon cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • recurrent breast cancer
  • stage III gastric cancer
  • stage IV gastric cancer
  • recurrent gastric cancer
  • stage IIIB breast cancer
  • recurrent non-small cell lung cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • recurrent pancreatic cancer
  • stage III rectal cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • refractory multiple myeloma
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • stage III multiple myeloma
  • stage III prostate cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • male breast cancer
  • stage IV pancreatic cancer
  • Breast Neoplasms
  • Neoplasms
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Colorectal Neoplasms
  • Lung Neoplasms
  • Stomach Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Pancreatic Neoplasms
  • Prostatic Neoplasms