Status:
COMPLETED
Aurora Kinase Inhibitor AT9283 in Treating Patients With Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma
Lead Sponsor:
NCIC Clinical Trials Group
Collaborating Sponsors:
Astex Pharmaceuticals, Inc.
Conditions:
Non-Hodgkins Lymphoma
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Aurora kinase inhibitor AT9283 (AT9283) may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects...
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose and recommended phase II dose of Aurora kinase inhibitor AT9283 (AT9283) in patients with incurable advanced or metastatic solid tumors or non-Hodgk...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed diagnosis of 1 of the following:
- Advanced and/or metastatic solid tumor
- Advanced or metastatic non-Hodgkin's lymphoma refractory to standard therapy
- Clinically or radiologically documented disease
- No tumor marker elevation as only evidence of disease
- No untreated brain or meningeal metastases
- Treated and stable brain metastases allowed provided they are asymptomatic and do not require steroids
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 1.25 times upper limit of normal (ULN) OR creatinine clearance ≥ 50 mL/min
- Bilirubin normal
- ALT and AST ≤ 2 times ULN (≤5 times ULN if liver metastases are present)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use two effective methods of contraception
- No untreated or uncontrolled hypertension, cardiovascular conditions, or symptomatic cardiac dysfunction
- No active or uncontrolled infections
- No serious illness or medical condition that would preclude study treatment
- PRIOR CONCURRENT THERAPY:
- At least 2 weeks since prior major surgery and recovered
- At least 3 weeks since prior palliative radiotherapy and recovered
- Low-dose, nonmyelosuppressive radiotherapy may be allowed
- At least 3 weeks since prior chemotherapy for solid tumors and recovered
- No more than 2 prior cytotoxic chemotherapy regimens for metastatic disease
- At least 4 weeks since prior steroids
- No limitations on prior therapy for patients with non-Hodgkin's lymphoma
- Prior hormonal, immunologic, biologic or signal transduction inhibitor therapy allowed
- No other concurrent investigational agents
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
January 30 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2012
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00443976
Start Date
January 30 2007
End Date
January 6 2012
Last Update
August 4 2023
Active Locations (2)
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1
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
2
Ottawa Health Research Institute - General Division
Ottawa, Ontario, Canada, K1H 8L6