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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.