Clinical trial · Interventional
Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver Dysfunction
A Phase I Pharmacokinetic Study of STI571 in Patients With Advanced Malignancies and Varying Levels of Liver Dysfunction
NCT00025415CI-TRIAL-00009351completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase I trial to study the effectiveness of imatinib mesylate in treating patients who have advanced cancer and liver dysfunction
Conditions
Conditions (81)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Accelerated Phase Chronic Myelogenous Leukemia | Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Acute Undifferentiated Leukemia | Acute Undifferentiated Leukemia | ONTOLOGY_EXACT | 0.90 |
| AIDS-related Peripheral/Systemic Lymphoma | — | UNRESOLVED | — |
| AIDS-related Primary CNS Lymphoma | AIDS-Related Primary Central Nervous System Lymphoma | ALIAS | 0.90 |
| Anaplastic Large Cell Lymphoma | Anaplastic Large Cell Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Angioimmunoblastic T-cell Lymphoma | Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type | ALIAS | 0.90 |
| Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative | Atypical Chronic Myeloid Leukemia | ALIAS | 0.90 |
| Blastic Phase Chronic Myelogenous Leukemia |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (imatinib mesylate)
- description
- Patients receive oral imatinib mesylate daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients within each stratum (except normal stratum) receive escalating doses of imatinib mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
- interventionNames
- Drug: imatinib mesylate
- Other: pharmacological study
Primary outcomes (2)
- measure
- MTD defined based on the toxicities observed during the first cycle of treatment
- timeFrame
- 4 weeks
- measure
- Toxicity evaluation graded according to the NCI common toxicity criteria and relationship to the study drug
- timeFrame
- Up to 4 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically or cytologically confirmed surgically incurable solid tumor orhematologic malignancy for which no standard or palliative therapy exists oris no longer effective
* All tumor types are eligible, including:
* Chronic myelogenous leukemia or other Philadelphia chromosome-positive leukemia OR
* Gastrointestinal stromal tumors
* Patients with gliomas that require corticosteroids or anticonvulsants must beon a stable dose and seizure-free for 1 month
* No unstable or untreated (non-irradiated) brain metastases
* Performance status - ECOG 0-2
* Performance status - Karnofsky 60-100%
* More than 3 months
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* No active hemolysis
* See Surgery
* No evidence of biliary sepsis
* Creatinine normal
* Creatinine clearance at least 60 mL/min
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Able to swallow pills
* No other uncontrolled concurrent illness that would preclude study participation
* No ongoing or active infection
* No uncontrolled diarrhea
* No psychiatric illness or social situation that would preclude study compliance
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for 6 months after study completion
* At least 24 hours since prior colony-stimulating factors
* No concurrent colony-stimulating factors
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
* See Disease Characteristics
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy and recovered
* See Disease Characteristics
* At least 10 days since prior placement of shunt for treatment of biliary obstruction
* At least 14 days since prior major surgery
* No prior solid organ transplantation
* No other concurrent investigational agents
* No concurrent therapeutic doses of warfarin for anticoagulation
* No other concurrent investigational or commercial agents or therapies for treatment of this disease
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No concurrent acetaminophen of more than 4,000 mg/dayReferences
Publications (0)
Data not yet available
No reference posted for this study.