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

This study has been completed.
Sponsor:
Collaborator:
OSI Pharmaceuticals
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00603356
First received: December 26, 2007
Last updated: September 26, 2011
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Advanced Solid Tumors
Drug: OSI-930 and erlotinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation Study of Daily Oral OSI-930 and Erlotinib (Tarceva) in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Determine the maximum tolerated dose (MTD), evaluate the pharmacokinetic profiles [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety, evaluate pharmacodynamic relationships [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: November 2007
Study Completion Date: July 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dose Escalation
Drug: OSI-930 and erlotinib
OSI-930 administered daily in combination with Erlotinib at increasing doses until disease progression or unacceptable toxicity

Detailed Description:

Multicenter, open-label, phase 1, dose escalation study to determine the maximum tolerated dose of OSI-930 and Erlotinib.

Patients may continue to receive OSI-930 and Erlotinib until one of the following occurs: disease progression, adverse event requiring withdrawal, failure to recover from toxicity despite a 14-day dosing interruption, medical or ethical reasons, patient request, or patient death.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Accessible for repeat dosing and follow-up
  • Adequate hematopoietic, hepatic, and renal function

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603356

Locations
United States, Florida
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Sponsors and Collaborators
Astellas Pharma Inc
OSI Pharmaceuticals
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00603356     History of Changes
Other Study ID Numbers: OSI-930-103
Study First Received: December 26, 2007
Last Updated: September 26, 2011
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
GIST
Ovarian Cancer
Mesothelioma
Renal
Colorectal Cancer
Sarcoma
NSCLC
Cancer

Additional relevant MeSH terms:
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014