Clinical trial · Interventional
Study of Oral OSI-027 in Patients With Advanced Solid Tumors or Lymphoma
A Phase 1 Dose-escalation Study of Intermittent, Once Weekly, and Continuous Daily Oral OSI-027 Dosing in Patients With Advanced Solid Tumors or Lymphoma
NCT00698243CI-TRIAL-00010048completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Any Solid Tumor or Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OSI-027 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Schedule 1
- description
- Once daily for 3 days every 7 days
- interventionNames
- Drug: OSI-027
- type
- EXPERIMENTAL
- label
- Schedule 2
- description
- Once weekly
- interventionNames
- Drug: OSI-027
- type
- EXPERIMENTAL
- label
- Schedule 3
- description
- Once daily
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * History of allergic reactions * Patients with cataract who are expected to undergo surgery within 6 months of registration * Use of drugs causing QT interval prolongation within 14 days prior to dosing * Patients with clinically significant electrolyte imbalances
References
Publications (0)
Data not yet available
No reference posted for this study.