Study of Continuous OSI-906 Dosing

NCT00514007 | Completed Phase 1

• 2 other identifiers: OSI-906-1012006-005937-39
• Study Type: interventional
• Target: 95
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Advanced Solid Tumors

Keywords

Advanced Cancer; Colorectal cancer; Ovarian cancer; Renal cancer; Metastatic cancer; Breast cancer; Non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Determine the maximum tolerated dose (MTD) for both the once daily (QD) and twice daily (BID) dosing schedules and establish a recommended phase 2 dose of oral OSI-906

  21 days

Secondary Outcomes (1)

• Safety profile; Pharmacokinetic (PK) profile; Pharmacodynamic relationships and preliminary antitumor activity

  2.5 years

Study Arms (2)

OSI-906 QD

EXPERIMENTAL

Once per day

Drug: OSI-906

OSI-906 BID

EXPERIMENTAL

Twice per day

Drug: OSI-906

Interventions

OSI-906 DRUG

OSI-906 administered orally

OSI-906 BID; OSI-906 QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (2)

Vanderbilt Universtiy Medical Center

Nashville, Tennessee, 37232-6307, United States

Location

The Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Conditions

Colorectal Neoplasms; Ovarian Neoplasms; Kidney Neoplasms; Neoplasm Metastasis; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

3-(8-amino-1-(2-phenylquinolin-7-yl)imidazo(1,5-a)pyrazin-3-yl)-1-methylcyclobutanol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Urologic Neoplasms; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2007
• First Posted: August 9, 2007
• Study Start: June 18, 2007
• Primary Completion: March 19, 2012
• Study Completion: March 19, 2012
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

Locations

US (1); GB (1)