Phase 1 Study of OSI-930 in Cancer Patients

NCT00513851 | Completed Phase 1

• 1 other identifier: OSI-930-102
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 3

Brief Summary

Open label, phase 1, dose escalation

Conditions

Advanced Solid Tumors

Keywords

Advanced Cancer; Non-small cell lung cancer; Small cell lung cancer; Uterine cancer; Ovarian cancer; Renal cancer; Head and neck cancer; Cervical cancer; Metastatic cancer; Colorectal cancer; Gastrointestinal stromal tumors

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 OSI-930

  2.5 years

Secondary Outcomes (1)

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

  2.5 years

Study Arms (2)

1

EXPERIMENTAL

Once Daily Dosing

Drug: OSI-930

2

EXPERIMENTAL

Twice Daily Dosing

Drug: OSI-930

Interventions

OSI-930 DRUG

Oral OSI-930 administered once daily at increasing doses until disease progression or unacceptable toxicity

1

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.
• Age \>/= 18 years, ECOG 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 it did not exceed 25% of bone marrow reserve and patients have recovered from the toxic effects. A minimum of 21 days must have elapsed unless the radiotherapy was palliative and nonmyelosuppressive.
• ANC \>/= 1.5 x 10\^9/L, PLT \>/= 100 x 10\^9/L; bilirubin \</= 1.5 x upper limit of normal (ULN), AST and ALT \</= 2.5 x ULN; creatinine \</= 1.5 ULN Accessible for repeat dosing and follow-up. Patients must practice effective contraceptive measures throughout the study. Provide written informed consent.

You may not qualify if:

• Symptomatic brain metastases which are not stable, require steroids, are potentially life-threatening or that have required radiation within the last 28 days.
• History of allergic reaction attributed to a similar compound as study drug. Significant cardiac disease unless well controlled, poorly controlled hypertension.
• Active or uncontrolled infections of serious illnesses or medical conditions that could interfere with participation.
• History of any psychiatric condition that might impair the patient's ability to provide informed consent or participate.
• Concurrent anticancer therapy. Use of CYP3A4 inducers/inhibitors during the 14 days prior to first dose. Pregnant or breast-feeding females.

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• OSI Pharmaceuticals: collaborator

Study Sites (3)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Cancer Research UK Professor of Medical Oncology

Sutton, Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Uterine Neoplasms; Ovarian Neoplasms; Kidney Neoplasms; Head and Neck Neoplasms; Uterine Cervical Neoplasms; Neoplasm Metastasis; Colorectal Neoplasms; Gastrointestinal Stromal Tumors

Interventions

OSI 930

Condition Hierarchy (Ancestors)

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

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: April 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 27, 2011

Record last verified: 2011-09

Locations

US (2); GB (1)