A Phase 1 Dose-escalation Study of OSI-906 and Erlotinib (Tarceva®)

Study summary

Multicenter, open-label, phase 1, cohort dose escalation study to determine the Maximum Tolerated Dose (MTD) of OSI-906 in combination with erlotinib

Ask AI to explain this study

Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedOSI-906 and erlotinib

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?4 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; Drug: erlotinib

Explore related studies

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 confirmed advanced solid tumor
For the NSCLC Expansion Cohort, a confirmed diagnosis of stage IIIB/IV NSCLC after failure of at least 1 prior chemotherapy regimen is required
Patients with Eastern Cooperative Oncology Group (ECOG) performance status \</= 2
Predicted life expectancy \>/= 12 weeks
Patients may have had prior therapy, providing certain conditions are met: 1. Chemotherapy: A minimum of 3 weeks (4 weeks for carboplatin or investigational anticancer agents and 6 weeks for nitrosoureas and mitomycin C) must have elapsed between the end of treatment and registration into this study. Patients must have recovered from any treatment-related toxicities (except for alopecia, fatigue, and grade 1 neurotoxicity) prior to registration. 2. Hormonal therapy: Patients may have had prior anticancer hormonal therapy provided it is discontinued prior to registration into the study. However, patients with prostate cancer with evidence of progressive disease may continue on therapy that produces medical castration (eg, goserelin or leuprorelin), provided this therapy was commenced at least 3 months earlier. 3. Radiation: Patients may have had prior radiation therapy provided they have recovered from the acute, toxic effects of radiotherapy prior to registration. A minimum of 21 days must have elapsed between the end of radiotherapy and registration into the study unless the radiation affected less than 25% of bone marrow. 4. Surgery: Previous surgery is permitted provided that wound healing has occurred prior to registration.
Fasting glucose \</= 125 mg/dL (7 mmol/L) at baseline and on Day 1 prior to dosing
Blood ketones \</= Upper Limit of Normal (ULN)
Neutrophil count \>/= 1.5 x 10\^9/L
Platelets \>/= 100 x 10\^9/L
Bilirubin \</= 1.5 x ULN
AST and/or ALT \</= 2.5 x ULN or \</= 5 x ULN if patient has documented liver metastases
Serum creatinine \</= 1.5 x ULN
Patients must be nonsmokers (or former smokers who stopped smoking \> 3 months previously) and have a negative cotinine test at baseline and on Day 1
Patients in the NSCLC Expansion Cohort must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST)
Patients in the NSCLC Expansion Cohort will be required to have either an archival or fresh tumor tissue (whole or partial block) available at the start of study
Patients must be accessible for repeat dosing and follow-up, including pharmacokinetic sampling
Patients - both males and females - with reproductive potential must agree to practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test at baseline and on Day 1
Patients must provide verbal and written informed consent to participate in the study

Reasons someone may not be able to joinExclusion criteria

Documented history of diabetes mellitus
History of significant cardiac disease unless the disease is well-controlled. Significant cardiac diseases includes second/third degree heart block; significant ischemic heart disease; QTc interval \> 450 msec at baseline; poorly controlled hypertension; congestive heart failure of New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea)
History of cerebrovascular accident (CVA) within 12 months prior to registration or that is not stable
Prior epidermal growth factor receptor (EGFR) or insulin like growth factor receptor (IGFR) inhibitor therapy, except for prior erlotinib therapy in the NSCLC Expansion Cohort, prior erlotinib therapy will not be exclusionary
History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent
Pregnant or breast-feeding females
Gastrointestinal (GI) abnormalities including inability to take oral medication, requirement for intravenous (IV) alimentation, active peptic ulcer, or prior surgical procedures affecting absorption
Ocular inflammatory or infectious condition that is not completely resolved prior to registration
History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug
Any type of active seizure disorder
Use of drugs that have a risk of causing QT interval prolongation within 14 days prior to Day 1 dosing
Use of strong or moderate CYP3A4 or CYP1A2 inhibitors/inducers, with the exception of low-dose steroids, within 14 days prior to Day 1 dosing
Use of proton pump inhibitors within 14 days prior to day 1 dosing
Symptomatic brain metastases that are not stable, require steroids, or that have required radiation within the last 28 days
Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient's ongoing participation in the study

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

University of Colorado Health Science CenterAurora, Colorado
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland
Hudson-Webber Cancer Research Center, Karmanos Cancer InstituteDetroit, Michigan
University of Oxford Department of Medical OncologyOxford

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

View original record ↗