Study of Oral OSI-027 in Patients With Advanced Solid Tumors or Lymphoma (NCT00698243) | Clinical Trial Compass
CompletedPhase 1
Study of Oral OSI-027 in Patients With Advanced Solid Tumors or Lymphoma
United States, Belgium, United Kingdom128 participantsStarted 2008-06
Plain-language summary
The primary objective of this study is to determine the maximum tolerated dose (MTD) and to establish the recommended phase 2 dose of oral OSI-027 when administered via 3 schedules, namely, intermittent, weekly, and continuous in patients with advanced solid tumors or lymphoma, namely, intermittent, weekly, and continuous.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically or cytologically documented malignancy (solid tumor or lymphoma)
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
* Predicted life expectancy of at least 3 months
* Adequate hematopoietic and hepatic function, and normal renal function
* Fasting glucose \<7mmol/L at baseline
* Left ventricular ejection fracture (LVEF) by Multiple gated acquisition scan (MUGA)≥ 60%
* Practice effective contraceptive measures throughout study
* Verbal and written informed consent
* Prior therapy:
* Chemotherapy, minimum of 3 weeks and recovered from any treatment-related toxicities (except for alopecia, and grade 1 neurotoxicity) prior to registration
* Hormonal, discontinued prior to registration
* Radiation, minimum of 21 days and recovered from toxic effects prior to registration
* Surgery, provided wound healing has occurred
Exclusion Criteria:
* History of significant cardiac disease unless well controlled
* Discontinuation from prior therapy due to cardiac toxicity
* Active or uncontrolled infections
* Serious illness or medical condition that could interfere with study participation
* History of any psychiatric condition that might impair understanding or compliance
* Documented history of diabetes mellitus
* Pregnant or breastfeeding females
* Unstable symptomatic brain metastases, that require steroid or that have required radiation in the last 28 days
* Chronic systemic steroid use for cancer related condition
* His…