Trials / Completed
CompletedNCT00646139
KX2-391 in Treating Patients With Advanced Solid Tumors or Lymphoma That Did Not Respond to Treatment
A Combined Rising Single-Dose (RSD) and Rising Multiple-Dose (RMD) Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of KX2-391 in Patients With Advanced Malignancies That Are Refractory to Conventional Therapies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- Roswell Park Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: KX2-391 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 and best dose of KX2-391 in treating patients with advanced solid tumors or lymphoma that did not respond to treatment.
Detailed description
OBJECTIVES: Primary * To define the maximum tolerated dose of KX2-391 when administered as multiple oral solutions in patients with refractory advanced solid tumors and lymphoma. Secondary * To determine the safety and tolerability of KX2-391 given as single and multiple oral solutions in these patients. * To characterize the pharmacokinetic profile of single dosing and multiple dosing of KX2-391 in these patients. * To determine the biological effects of KX2-391. OUTLINE: This is a multicenter study. Patients receive oral KX2-391 once or twice daily for 3 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Blood and urine samples are collected periodically for pharmacokinetic studies. Biological effects are assessed by measuring plasma levels of vascular endothelial growth factor by ELISA. Levels of phospho-Src Tyr and transphosphorylation of selected substrates are measured in peripheral blood mononuclear cells.
Conditions
- Lymphoma
- Lymphoproliferative Disorder
- Small Intestine Cancer
- Unspecified Adult Solid Tumor, Protocol Specific
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Src kinase inhibitor KX2-391 | |
| OTHER | immunoenzyme technique | |
| OTHER | pharmacological study |
Timeline
- Start date
- 2007-10-01
- Primary completion
- 2008-08-01
- Completion
- 2009-03-01
- First posted
- 2008-03-28
- Last updated
- 2011-03-02
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00646139. Inclusion in this directory is not an endorsement.