Phase I Study of OSI-930 and Erlotinib in Cancer Tumors

NCT00603356 | Completed Phase 1

• 1 other identifier: OSI-930-103
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

Brief Summary

This is a Phase I, dose escalation, safety study of OSI-930 and Erlotinib in cancer tumors.

Conditions

Advanced Solid Tumors

Keywords

GIST; Ovarian Cancer; Mesothelioma; Renal; Colorectal Cancer; Sarcoma; NSCLC; Cancer

Outcome Measures

Primary Outcomes (1)

• Determine the maximum tolerated dose (MTD), evaluate the pharmacokinetic profiles

  18 months

Secondary Outcomes (1)

• Safety, evaluate pharmacodynamic relationships

  18 months

Study Arms (1)

1

EXPERIMENTAL

Dose Escalation

Drug: OSI-930 and erlotinib

Interventions

OSI-930 and erlotinib DRUG

OSI-930 administered daily in combination with Erlotinib 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:

• Histology 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 greater than or equal to 18 years
• ECOG PS 0-2
• ANC greater than or equal to 1.5 x 10\^9/L
• Bilirubin less than or equal to 1.5 x upper limit of normal (ULN), AST and ALT less than or equal to 2.5 x ULN
• Creatinine less than or equal to 1.5 ULN
• Predicted life expectancy greater than or equal to 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)
• Prior surgery is permitted, provided that wound healing has occurred prior to registration
• Patients must use proactive effective contraceptive measures throughout the study
• Provide written informed consent

You may not qualify if:

• Significant cardiac disease unless well controlled
• Current or former smokers, unless patients stopped smoking greater than 3 months prior to registration
• Active or uncontrolled infections of serious illnesses or medical conditions that could interfere with participation
• History of unacceptable toxicity with previous EGFR inhibitor therapy
• History of any psychiatric condition that might impair the patient's ability to provide informed consent or participate
• Use of CYP3A4 inducers/inhibitors during the 14 days prior to first dose
• Pregnant or breast-feeding females
• 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
• GI abnormalities including inability to take oral medications, required for IV alimentation
• Clinically significant ophthalmologic abnormalities

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• OSI Pharmaceuticals: collaborator

Study Sites (2)

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

The Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Mesothelioma; Colorectal Neoplasms; Sarcoma; Neoplasms

Interventions

OSI 930; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; 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; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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: December 26, 2007
• First Posted: January 29, 2008
• Study Start: November 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: July 1, 2010
• Last Updated: September 27, 2011

Record last verified: 2011-09

Locations

US (1); GB (1)