Evaluation of KX2-391 in Patients With Advanced Malignancies (NCT00658970) | Clinical Trial Compass
CompletedPhase 1
Evaluation of KX2-391 in Patients With Advanced Malignancies
United States50 participantsStarted 2007-11
Plain-language summary
The purpose of this Phase 1 study is to determine the safety and tolerability of KX2-391 in cancer patients.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed written informed consent
* Adults over age 18 years of age
* Confirmed advanced solid tumor or lymphoma that may be metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; patients with treated brain or ocular metastases are also eligible
* ECOG performance status of 0-2
* Life expectancy of at least 14 weeks
* Adequate bone marrow reserve
* Adequate liver function as demonstrated by serum bilirubin, alanine aminotransferase (ALT), aspartate transaminase (AST) and alkaline phosphatase (ALP)
* Adequate renal function (serum creatinine \</= 1.5 x ULN or calculated creatinine clearance \> 60 ml/min)
* Normal coagulation profile (PT/INR and aPTT within institutional normal limits) for those who give consent to tumor biopsy, within 1 week prior to the procedure.
* Negative pregnancy test for females at Screening, preferably done within 1 week before Day 1 of dosing (not applicable to patients with bilateral oophorectomy and/or hysterectomy)
* Willing to abstain from sexual activity or practice physical barrier contraception 28 days before Day 1 of dosing and 6 months after the last dose for the patient
* Signed written informed consent for tumor biopsy for the additional 10 subjects that will be dosed at the MTD and who have accessible tumors
Exclusion Criteria:
* Unresolved toxicity of higher than Grade 1 severity from previous anti-cancer treatment or investigational agents
* Recei…