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Clinical Trial Record

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

2008-10-23

2012-03-03

2012-03-03

95

Study Overview

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

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

The study will open with Schedule 1 (S1), in which OSI-906 is administered on Days 1-3 every 7 days. Erlotinib will be administered daily starting on Day 2. A treatment period is defined as 21 days. Initiation of Schedule 2 (S2), in which OSI-906 is administered daily starting on Day 1 and erlotinib is administered daily starting on Day 2, will occur after observation of clinically significant related toxicity >/= grade 2 in any patient on S1 or after > 2 dose levels in S1 have been examined without evidence of Dose Limiting Toxicities (DLT). Initiation of Schedule 3 (S3), in which OSI-906 is administered twice daily starting on Day 1 and erlotinib is administered daily starting on Day 2, will occur after observation of clinically significant related toxicity >/= grade 2 in any patient on S2 or after > 2 dose levels in S2 have been examined without evidence of DLT. Once the phase 2 dose has been established for S3, 1 expansion cohort will be opened. The Expansion Cohort will enroll approximately 30 evaluable patients with stage IIIB/IV Non-small Cell Lung Carcinoma (NSCLC). Patients in the NSCLC Expansion Cohort will be required to have either archival tissue or fresh tumor tissue available at the start of study.

  • Advanced Solid Tumors
  • DRUG: OSI-906
  • DRUG: erlotinib
  • OSI-906-103
  • 2008-001743-20 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2008-08-19  

N/A  

2024-11-18  

2008-08-19  

N/A  

2024-11-20  

2008-08-21  

N/A  

2024-11  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Schedule 1

OSI-906 is administered on Days 1-3 every 7 days. Erlotinib will be administered daily starting on Day 2 of the initial treatment period and on Day 1-21 for all remaining treatment periods.

DRUG: OSI-906

  • administered orally

DRUG: erlotinib

  • administered orally
EXPERIMENTAL: Schedule 2

OSI-906 is administered daily starting on Day 1 and erlotinib is administered daily starting on Day 2 of the initial treatment period and on Day 1-21 for all remaining treatment periods.

DRUG: OSI-906

  • administered orally

DRUG: erlotinib

  • administered orally
EXPERIMENTAL: Schedule 3

OSI-906 is administered continuously twice daily starting on Day 1 and erlotinib is administered daily starting on Day 2. The NSCLC expansion cohort will follow Schedule 3 with the exception that erlotinib is administered daily starting on Day 8.

DRUG: OSI-906

  • administered orally

DRUG: erlotinib

  • administered orally
Primary Outcome MeasuresMeasure DescriptionTime Frame
Determine the maximum tolerated dose (MTD) and recommended phase 2 dose of OSI-906 and erlotinib21 days
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Safety profile, Pharmacokinetic profile, pharmacodynamic activity, Preliminary antitumor activity3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion 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
  • 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
  • Blood ketones
  • Neutrophil count >/= 1.5 x 10^9/L
  • Platelets >/= 100 x 10^9/L
  • Bilirubin
  • AST and/or ALT
  • Serum creatinine
  • 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

    • Exclusion 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • STUDY_DIRECTOR: Sr. Medical Director, Astellas Pharma Global Development

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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