Study of Continuous OSI-906 Dosing

Study summary

Multicenter, open-label, phase 1, cohort dose escalation study to determine the Maximum Tolerated Dose (MTD) on both Once Daily (QD) and Twice Daily (BID) schedules.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedOSI-906

The study team can explain what participation involves.

Who it may be forAdvanced Solid Tumors

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 20, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Astellas Pharma Inc

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Astellas Pharma Inc
Interventions being studied: Drug: OSI-906

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Histologically or cytologically documented malignancy that is now advanced and/or metastatic and refractory to established forms of therapy or for which no effective therapy exists. Patients in the Biomarker Expansion Cohort must have histologically documented colorectal cancer that is locally advanced or metastatic and refractory to established forms of therapy. These patients must have archival tissue available and a lesion accessible for biopsy
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2, life expectancy ≥ 12 weeks
Prior chemotherapy is permitted provided that a minimum of 3 weeks has elapsed. Prior tyrosine kinase inhibitor therapy is permitted. Patients must have recovered from any treatment-related toxicities (with some exceptions) prior to registration
Prior hormonal therapy is permitted provided it is discontinued prior to registration (with the exception of prostate cancer patients who have been on hormone therapy for at least 3 months)
Prior radiation therapy is permitted provided that patients have recovered from the toxic effects. A minimum of 21 days must have elapsed unless the radiotherapy was palliative and nonmyelosuppressive
Prior surgery is permitted provided that wound healing has occurred prior to registration
Fasting glucose ≤ 125 mg/dL (7 mmol/L) at baseline (all patients except those in the Diabetic Expansion Cohort). Patients in the Diabetic Expansion Cohort must have a fasting glucose of ≤ 150 mg/dL (8.3 mmol/L) at baseline. If patients in the Diabetic Expansion Cohort are being treated with non-insulinotropic oral antihyperglycemic therapy, doses must be stable for ≥ 4 weeks prior to registration
Potassium, calcium, and magnesium must be within normal limits (WNL). Electrolyte abnormalities will be permitted if they are not clinically significant and if treatment for the abnormality is initiated prior to Day 1
Neutrophil ≥ 1.5 x 10\^9/L, Platelet (PLT) ≥ 100 x 10\^9/L; bilirubin ≤ 1.5 x upper limit of normal (ULN), AST and ALT ≤ 2.5 x ULN or ≤ 5 x UNL if patient has documented liver metastases; creatinine ≤ 1.5 x ULN
Accessible for repeat dosing and follow-up, including pharmacokinetic sampling
Patients must practice effective contraceptive measures throughout the study
Provide written informed consent

Reasons someone may not be able to joinExclusion criteria

History of any kind of stroke
History of any psychiatric condition that might impair the patient's ability to provide informed consent or participate
History of allergic reaction attributed to a similar compound as study drug.
Any type of active seizure disorder
Previously diagnosed brain metastases
Concurrent anticancer therapy
Active or uncontrolled infections of serious illnesses or medical conditions that could interfere with participation
Pregnant or breast-feeding females
Documented history of diabetes mellitus (all patients except those in the Diabetic Expansion Cohort). Patients in the Diabetic Expansion Cohort may not have Type 1 diabetes mellitus or Type 2 diabetes mellitus currently requiring insulinotropic or insulin therapy
Use of drugs with a risk of causing QT interval prolongation within 14 days prior to Day 1 and while on study
Use of glucocorticoids within 14 days prior to Day 1 and while on study
History of significant cardiac disease unless well controlled (includes 2nd/3rd degree heart block, ischemic heart disease, QTc \> 450 msec, poorly controlled hypertension, or congestive heart failure of New York Heart Association (NYHA) Class II or worse)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Vanderbilt Universtiy Medical CenterNashville, Tennessee
The Beatson West of Scotland Cancer CentreGlasgow

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 20, 2024. Always confirm current availability with the study team.

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