Study of Intermittent OSI-906 Dosing

NCT00514306 | Completed Phase 1

• 2 other identifiers: OSI-906-1022006-005938-20
• Study Type: interventional
• Target: 79
• Locations: 2 countries
• Sites: 2

Brief Summary

Multicenter, open-label, phase 1, cohort dose escalation study to determine the maximum tolerated dose (MTD) of 3 intermittent OSI-906 dosing schedules.

Conditions

Advanced Solid Tumors

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Determine the maximum tolerated dose (MTD) for each of 3 intermittent schedules and establish a recommended phase 2 dose of OSI-906

  14 days

Secondary Outcomes (1)

• Safety profile, Pharmacokinetic profile, Pharmacodynamic relationships Preliminary antitumor activity

  3 years

Study Arms (3)

Schedule 1

EXPERIMENTAL

OSI-906 days 1-3 every 14 days

Drug: OSI-906

Schedule 2

EXPERIMENTAL

OSI-906 days 1-5 every 14 days

Drug: OSI-906

Schedule 3

EXPERIMENTAL

OSI-906 days 1-7 every 14 days

Drug: OSI-906

Interventions

OSI-906 DRUG

Oral OSI-906 administered on an intermittent schedule at increasing doses until disease progression or unacceptable toxicity

Schedule 1; Schedule 2; Schedule 3

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 with Eastern Cooperative Oncology Group (ECOG) performance status \</= 2
• Predicted life expectancy ≥ 12 weeks
• Patients may have had prior therapy, providing the following conditions are met:
• 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. Prior tyrosine kinase inhibitor therapy is permitted. Patients must have recovered from any treatment-related toxicities (except for alopecia, fatigue, and grade 1 neurotoxicity) prior to registration
• Hormonal therapy: Patients may have had prior anticancer hormonal therapy provided it is discontinued prior to registration into this 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
• 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 radiotherapy was palliative and nonmyelosuppressive
• Surgery: Previous surgery is permitted provided that wound healing has occurred prior to registration
• Fasting glucose ≤ 125 mg/dL (7 mmol/L) at baseline
• 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
• Adequate hematopoietic, hepatic, and renal function defined as follows:
• Neutrophil count ≥ 1.5 x 10\^9/L and platelet count ≥ 100 x 10\^9/L
• Bilirubin ≤ 1.5 x ULN or ≤ 3 x ULN if patient has Gilbert's disease
• AST and/or ALT ≤ 2.5 x ULN or ≤ 5 x UNL if patient has documented liver metastases
• Serum creatinine ≤ 1.5 x ULN

You may not qualify if:

• 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)
• Any type of active seizure disorder
• Concurrent anticancer therapy (with the exception of hormonal therapy as described above)
• 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 dosing and while on study, with the exception of hormone replacement therapy or inhalers
• History of any kind of stroke
• Previously diagnosed brain metastases (includes active brain metastases)
• Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient's ongoing participation in the study
• 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
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (2)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Drug Development Unit, Royal Marsden Hospital

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Conditions

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

Interventions

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Medical Monitor

  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: July 5, 2007
• Primary Completion: September 20, 2010
• Study Completion: September 20, 2010
• 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

GB (1); US (1)