HER2 or EGFR Expressing Advanced Solid MalignanciesPhase 1NCT00207012
MAD Refractory: Solid Tumor QD w/o Break
A Phase 1 study testing BMS-599626 in people with HER2 or EGFR Expressing Advanced Solid Malignancies, run by Bristol-Myers Squibb at 2 sites in 2 countries.
Trial summary
This is a continuous dosing Phase I Study of BMS-599626 in patients with HER2-expressing advanced solid malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2 or EGFR Expressing Advanced Solid Malignancies
- What is being tested?
- BMS-599626
- How many people
- 45 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2004to Feb 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Available for periodic follow-up
- Life expectancy of at least 3 months
- ECOG performance status score 0-1
- Histologic or cytologic diagnosis of a primary malignancy of breast, ovarian, bladder, gastric, non small cell lung or colon origin
- Tumor paraffin tissue block or 20-30 unstained slides from tumor issue block must be provided for biomarker and predictive marker analyses
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- Immuno-histochemistry (IHC) analysis of tumor biopsy demonstrating 1+, 2+ or 3+ HER3 expression or EGFR expression. For patients with breast cancer tumors must be HER2 FISH positive (fluorescence in situ hybridization). This analysis may be performed by hospital laboratory
- Evidence (radiographic or tissue confirmation) that the disease is metastatic (locally advanced disease is allowable only if no surgical or local therapeutic option exists)
- 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
- Adequate bone marrow function defined as:
- absolute neutrophil count (neutrophil and bands)
- >=1,500 cells/mm3
- platelet count >=1000,000 cells/mm3
- hemoglobin >= 9.0 g/dl
- Adequate hepatic function defined as:
- total bilirubin <= 1.5 times the institutional upper limits of normal
- alanine aminotransferase (ALT) and aspartate aminotransferase (AST)<=2.5 times the institutional upper limit of normal
- Adequate renal function defined as:
- serum creatine <=1.5 times the institutional upper normal limit
- PT-INR/PTT ,=1.5 x upper limit of normal. Prophylactic coumadin is allowed
- Serum potassium, calcium and magnesium levels within institutional normal limits
- Prior anticancer chemo-, radio-, hormonal or immunotherapy are allowed. Patients must have recovered from toxicity due to prior therapy (i.e., toxicity has resolved to baseline or is deemed irreversible). At least 4 weeks must hav elapsed since the last chemotherapy (6 weeks for nitrosoureas, mitomycin-C, and liposomal doxorubicin), immunotherapy or radiotherapy and beginning of protocol therapy. At least 2 weeks must have elapsed since last anticancer hormonal therapy or "targeted" kinase inhibitor (e.g. Herceptin)
- Men and women, ages 18 and above
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 3 months after the study in such a manner that the risk of pregnancy is minimized
- WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g. vasectomy) should be considered to be of child bearing potential.
- WOCP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication.
Who cannot join
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for 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 if their sexual partners are WOCBP for the entire study period and for at least 3 months after completion of the study
- Patients with known brain metastasis. Patients with controlled brain metastasis (no progression for 60 days following defined treatment and no neurologic signs or symptoms) will be allowed. Patients with signs or symptoms or suggestive of brain metastasis are not eligible unless brain metastasis are ruled out by CT or MRI
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- 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 4 months or left ventricular ejection fraction (LVEF) below lower limit of normal or below 45%
- 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)
- Any history of second or third degree heart block (may be eligible if currently have a pacemaker)
- Heart rate <50/minute on pre-entry electrocardiogram
- Uncontrolled hypertension
- Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
- Known allergy to BMS-599626 or related compound
- Investigational agents during or within 4 weeks prior to the start of protocol therapy
- Recent anticancer therapy
- Drugs (or medical condition) that are generally accepted to have a risk of causing Torsade de Pointes. Patients who have discontinued any of these medications must have a wash-out period of at least 5 days or at least 5 half-lives of the drug (whichever is greater) prior to the first dose of BMS-599626
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Continuous Dosing Phase I Study of BMS-599626 in Patients With HER2-Expressing Advanced Solid Malignancies
This is a continuous dosing Phase I Study of BMS-599626 in patients with HER2-expressing advanced solid malignancies.
- Being tested
- BMS-599626
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-599626Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated, biologically active doses and recommended phase 2 dose(s) of BMS-599-626 when administered as a daily uninterrupted oral dose
Secondary outcomes (1)
Efficacy (Best Clinical Response)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 or EGFR Expressing Advanced Solid MalignanciesStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207012
- Sponsor's protocol ID
- CA181-003
- Status last verified
- Jan 2009
- First submitted
- 12 Sep 2005
- Last updated
- 2 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Dosing Phase I Study of BMS-599626 in Patients With HER2-Expressing Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT00207012
- Acronym / sponsor ID
- CA181-003
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Feb 2006 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a continuous dosing Phase I Study of BMS-599626 in patients with HER2-expressing advanced solid malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Signed written informed consent
- Available for periodic follow-up
- Life expectancy of at least 3 months
- ECOG performance status score 0-1
- Histologic or cytologic diagnosis of a primary malignancy of breast, ovarian, bladder, gastric, non small cell lung or colon origin
Key exclusion criteria (23 listed)
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for 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 if their sexual partners are WOCBP for the entire study period and for at least 3 months after completion of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-599626 | Drug | – |
Primary outcome
Determine the maximum tolerated, biologically active doses and recommended phase 2 dose(s) of BMS-599-626 when administered as a daily uninterrupted oral dose
1 secondary outcome
Efficacy (Best Clinical Response)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-599626 in people with HER2 or EGFR Expressing Advanced Solid Malignancies, run by Bristol-Myers Squibb at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the maximum tolerated, biologically active doses and recommended phase 2 dose(s) of BMS-599-626 when administered as a daily uninterrupted oral dose. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2010.