Any Solid Tumor or Lymphoma
Conditions
Keywords
OSI-027, Solid tumor, Lymphoma
Brief 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.
Detailed description
The study will open with Schedule 1 (S1, intermittent) with initiation of Schedule 2 (S2, weekly) and Schedule 3 (S3, continuous), which may occur in parallel after observation of clinically significant related dose limiting toxicity (DLT) in the S1 schedule. Dosing will be initiated on Day 1 with intermittent weekly dosing continuing for 21 days (1 Treatment Period). Expansion of Dose Escalation Cohorts may occur for S1 and S2 at the recommended phase 2 dose level(s) and a Biomarker Expansion Cohort may be opened in S1 and/or S2.
Interventions
DRUGOSI-027
Administered orally
Sponsors
Astellas Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose | 21 days |
Secondary
| Measure | Time frame |
|---|---|
| Safety profile of OSI-027 | up to 5 years |
| Pharmacokinetic profile of OSI-027 | up to 23 days |
| Preliminary pharmacodynamic relationship with OSI-027 systemic exposure | up to 23 days |
| Preliminary antitumor activity of OSI-027 | up to 5 years |
Countries
Belgium, United Kingdom, United States
Outcome results
None listed