NCT00646139CompletedPhase 1
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
Roswell Park Cancer Institute2 sites in 1 country7 target enrollmentStarted: October 2007Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 7
- Locations
- 2
- Primary Endpoint
- Maximum tolerated dose
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Maximum tolerated dose
Secondary Outcomes
- Safety
- Pharmacokinetics
- Biological effects
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Phase 1
Evaluation of KX2-391 in Patients With Advanced MalignanciesSolid TumorsLymphomaNCT00658970Athenex, Inc.50
Completed
Phase 2
Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With CancerAdult Solid TumorAdenocarcinoma of the ColonAdenocarcinoma of the RectumAdult Central Nervous System Germ Cell TumorAdult TeratomaBenign TeratomaEstrogen Receptor-negative Breast CancerEstrogen Receptor-positive Breast CancerFamilial Testicular Germ Cell TumorHER2-negative Breast CancerHER2-positive Breast CancerOvarian Immature TeratomaOvarian Mature TeratomaOvarian Monodermal and Highly Specialized TeratomaProgesterone Receptor-negative Breast CancerProgesterone Receptor-positive Breast CancerRecurrent Breast CancerRecurrent Colon CancerRecurrent Extragonadal Germ Cell TumorMale Breast CancerRecurrent Extragonadal Non-seminomatous Germ Cell TumorRecurrent Extragonadal SeminomaRecurrent Malignant Testicular Germ Cell TumorRecurrent MelanomaRecurrent Ovarian Germ Cell TumorRecurrent Rectal CancerStage III Extragonadal Non-seminomatous Germ Cell TumorStage III Extragonadal SeminomaStage III Malignant Testicular Germ Cell TumorStage III Ovarian Germ Cell TumorStage IV Breast CancerStage IV Colon CancerStage IV Extragonadal Non-seminomatous Germ Cell TumorStage IV Extragonadal SeminomaStage IV MelanomaStage IV Ovarian Germ Cell TumorStage IV Rectal CancerTesticular Immature TeratomaTesticular Mature TeratomaNCT01037790Abramson Cancer Center at Penn Medicine304
Completed
Phase 2
Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell LeukemiaLeukemia, T-CellNCT00095381BioCryst Pharmaceuticals20
Completed
Phase 1
XK469 in Treating Patients With Advanced Solid TumorsUnspecified Adult Solid Tumor, Protocol SpecificNCT00028548Barbara Ann Karmanos Cancer Institute22
Terminated
Phase 2
Celecoxib and Docetaxel or Pemetrexed in Treating Patients With Advanced Recurrent Non-Small Cell Lung CancerLung CancerNCT00520845Vanderbilt-Ingram Cancer Center23