AzTrials
AzTrials

NeoplasmsPhase 1NCT00099606

Phase I (PH I) Mad Refractory Solid Tumor Study

A Phase 1 study testing Dasatinib in people with Neoplasms, run by Bristol-Myers Squibb at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
Dasatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesin 2 countries
Study dates
Jul 2004to Jul 2007
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 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);
Show all 23Show fewer
  • 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:
  • serum creatinine <=1.5 times the institutional upper normal limit
  • Serum potassium and magnesium levels within institutional normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the lower limit of normal. Patients with low potassium and magnesium levels may be repleted to allow for protocol entry.
  • CD4+ T-cell counts of >=the institutional lower limit of normal.
  • Prior 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 have elapsed since the last chemotherapy (6 weeks for nitrosoureas, mitomycin-C, and liposomal doxorubicin), immunotherapy or radiotherapy and the beginning of protocol therapy. At least 2 weeks must have elapsed since last hormonal therapy or exposure to any other "targeted" kinase inhibitor (e.g., imatinib mesylate).
  • Bleeding time <=upper limit of institutional normal or platelet aggregometry result within the institutional normal limits
  • Men and women, ages 18 and older. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month prior and 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 [defined as amenorrhea >=12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level >35 mIU/mL]. 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.
  • WOCBP 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 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).
Show all 34Show fewer
  • 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)
  • 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;
  • History of significant bleeding disorder including:
  • Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
  • Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
  • Documented major bleeding episode from the GI tract within 6 months unless no longer at significant risk due to surgical intervention
  • Vasculitis.
  • Received investigational agents within 4 weeks prior to the start of protocol therapy.
  • Patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes including:
  • Class IA antiarrhythmic agents (quinidine, procainamide, disopyramide, mexiletine)
  • Class III antiarrhythmic agents ( amiodarone, sotalol, ibutilide, dofetilide)
  • Macrolide antibiotics (erythromycins, clarithromycin)
  • Antipsychotics (chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide)
  • Tricyclic antidepressants
  • Miscellaneous (cisapride, bepridil, inapsine, methadone, arsenic). 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-354825.
  • Patients taking medications that inhibit platelet function (e.g., aspirin, dipyridamole, epoprostenol, eptifibatide, clopidogrel, cilostazol, abciximab, ticlopidine, and any non-steroidal anti-inflammatory drug) or anticoagulants (warfarin, heparin/low molecular weight heparin [e.g., danaparoid, dalteparin, tinzaparin, enoxaparin]). Patients who have discontinued aspirin must have a wash-out period of at least 7 days for low-dose aspirin (<=325 mg/day) or 14 days for higher-dose aspirin (> 325 mg/day) prior to the first dose of BMS-354825. Patients who have discontinued other antiplatelet or anticoagulant 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-354825.
  • 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

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • Local Institution

    Boston, Massachusetts

  • Local Institution

    Detroit, Michigan

Other trials in United States

United Kingdom1 site

  • Local Institution

    Glasgow, Strathclyde

Other trials in United Kingdom

About this study

Official title: A Phase I Dose-Escalation Study of BMS-354825 in Patients With Refractory Solid Tumors

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.

Conditions
Neoplasms
Being tested
Dasatinib
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DasatinibDrug

    Also called Sprycel

    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.

Study groups in NCT00099606
Study groupRoleWhat they receive
A1ExperimentalNot described
Receives: Drug: Dasatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I-Dose Escalation to Determine MTD, Safety

Secondary outcomes (1)

  1. Pharmocokinetics

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2004 (estimated)
  2. Study startJul 2004
  3. Primary completionJul 2007
  4. Study completionJul 2007

Resources

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
Single group
Masking
None (open label)
Enrolment
60 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00099606
Sponsor's protocol ID
CA180-003
Status last verified
Apr 2011
First submitted
17 Dec 2004
Last updated
19 Apr 2011
Results posted
No

Publications

  • 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.

    PubMed 19789325

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dasatinib in people with Neoplasms, run by Bristol-Myers Squibb at 3 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 23 inclusion and 34 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 19 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, United Kingdom. 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?

Phase I-Dose Escalation to Determine MTD, Safety. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00099606, which also lists 1 linked publication.

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 19 Apr 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in