Phase I (PH I) Mad Refractory Solid Tumor Study
A Phase I Dose-Escalation Study of BMS-354825 in Patients With Refractory Solid Tumors
1 other identifier
interventional
60
2 countries
3
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, effect of food, and continue exploratory research of BMS-354825 in patients with solid tumors not responding to standard treatment, or for which no effective standard treatment exists.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2004
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 17, 2004
CompletedFirst Posted
Study publicly available on registry
December 20, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedApril 19, 2011
April 1, 2011
3 years
December 17, 2004
April 18, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Phase I-Dose Escalation to Determine MTD, Safety
Secondary Outcomes (1)
Pharmocokinetics
Study Arms (1)
A1
EXPERIMENTALInterventions
Tablets, Oral, Dose Finding Study - Range was 35 mg BID, 5 days on/2 days off - 120 mg BID Continuous Daily Dosing, Once daily, Patients remained on study until treatment discontinuation due to unacceptable toxicity, disease progression or death.
Eligibility Criteria
You may qualify if:
- Signed written informed consent
- Available for protocol-required follow-up
- ECOG performance status score 0 - 1 (See Appendix 1)
- Histologic or cytologic diagnosis of a primary solid (i.e., non-hematologic) malignancy
- Evidence (radiographic or tissue confirmation) that the disease is metastatic
- Metastatic disease which has progressed on or following currently available standard therapies or for which no standard therapy exists. (Prior adjuvant or neoadjuvant therapy is permitted. Prior investigational agents are permitted);
- Measurable or non-measurable disease as defined in Section 3.3.2.1
- Adequate bone marrow function defined as:
- absolute neutrophil count (neutrophil and bands) \>=2,000 cells/mm3
- platelet count \>=125,000 cells/mm3
- hemoglobin \>=9.0 g/dl
- Adequate hepatic function defined as:
- total bilirubin \<=1.5 times the institutional upper limit of normal,
- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<=2.0 times the institutional upper limit of normal
- Adequate renal function defined as:
- +8 more criteria
You may not qualify if:
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period including the period from one month prior to starting study medication and for a period of at least 3 months after the study.
- WOCBP using a prohibited contraceptive method.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or prior to study drug administration.
- Men who are unwilling or unable to use an acceptable method of birth control for the entire study period and for at least 3 months after completion of study medication if their sexual partners are WOCBP.
- Received extensive prior radiation therapy to the bone marrow. Generally, patients should have radiation to \<=25% of bone marrow-containing skeleton (see Appendix 2).
- Known brain metastasis. Patients with symptoms of brain metastasis are not eligible unless brain metastasis are ruled out by CT or MRI.
- A serious uncontrolled medical disorder or active infection which would impair the ability of the patient to receive protocol therapy.
- Uncontrolled or significant cardiovascular disease, including:
- A myocardial infarction within 12 months
- Uncontrolled angina within 6 months
- Congestive heart failure within 6 months
- Diagnosed or suspected congenital long QT syndrome
- Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsade de pointes). Any patient with a history of any arrhythmia should be discussed with the BMS Medical Monitor prior to entry into the study.
- Prolonged QTc interval on pre-entry electrocardiogram (\> 450 msec)
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Local Institution
Boston, Massachusetts, United States
Local Institution
Detroit, Michigan, United States
Local Institution
Glasgow, Strathclyde, United Kingdom
Related Publications (1)
Demetri GD, Lo Russo P, MacPherson IR, Wang D, Morgan JA, Brunton VG, Paliwal P, Agrawal S, Voi M, Evans TR. Phase I dose-escalation and pharmacokinetic study of dasatinib in patients with advanced solid tumors. Clin Cancer Res. 2009 Oct 1;15(19):6232-40. doi: 10.1158/1078-0432.CCR-09-0224. Epub 2009 Sep 29.
PMID: 19789325BACKGROUND
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 17, 2004
First Posted
December 20, 2004
Study Start
July 1, 2004
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
April 19, 2011
Record last verified: 2011-04