Know Cancer

or
forgot password

Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects Who Are Experiencing Clinical Benefit on Current START or CA180-039 Protocols: Long Term Safety and Efficacy Analysis


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Leukemia

Thank you

Trial Information

Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects Who Are Experiencing Clinical Benefit on Current START or CA180-039 Protocols: Long Term Safety and Efficacy Analysis


Inclusion Criteria:



- Signed Written Informed Consent

- Target Population (consistent with prior CA180039 and START protocols)

- Treatment on protocols CA180-005, CA180-006, CA180-013, CA180-015 or CA180-017,
or CA180-039

- Receiving clinical benefit with dasatinib or imatinib (study CA180017) in the
opinion of the Investigator

- Age and Sex

- Men and women, ages 18 and older may participate

- 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 (4 weeks) before and at least 3 months (12 weeks) after the last dose of
investigational product in such a manner that risk of pregnancy is minimized

Exclusion Criteria:

- Sex and Reproductive Status

- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for
the entire study period and for at least one month (4 weeks) before and for at least
3 months (12 weeks) after the last dose of study medication

- Women who are pregnant or breastfeeding

- Women with a positive pregnancy test on enrollment or prior to investigational
product administration

- Sexually active fertile men whose sexual partner(s) are WOCBP, who are unwilling or
unable to use an effective method to avoid pregnancy for the entire study period and
for at least 3 months (12 weeks) after completion of study medication

- Medical History and Concurrent Diseases

- A serious uncontrolled medical disorder or active infection that would impair
the ability of the subject to receive protocol therapy

- Dementia or altered mental status that would prohibit the understanding or
rendering of informed consent

- Prohibited Treatments and/or Therapies

- Subjects currently taking drugs that are generally accepted to have a risk of
causing Torsades de Pointes including, but not limited to:

- quinidine, procainamide, disopyramide

- amiodarone, sotalol, ibutilide, dofetilide

- erythromycins, clarithromycin

- chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide,
ziprasidone

- cisapride, bepridil, droperidol, methadone, arsenic, chloroquine,
domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin,
lidoflazine

- Subjects taking medications known to be potent CYP3A4 inhibitors (i.e.,
ketoconazole, ritonavir) or inducers (i.e., rifampin, efavirenz)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine long term safety and tolerability with Dasatinib

Outcome Time Frame:

Efficacy/ Safety and tolerability data assessed every 6 months

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA180-188

NCT ID:

NCT00982488

Start Date:

October 2007

Completion Date:

September 2014

Related Keywords:

  • Leukemia
  • Leukemia
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome

Name

Location

UCLA School of MedicineLos Angeles, California  900121973
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Oregon Health & Science UniversityPortland, Oregon  97201
University of Michigan Medical CenterAnn Arbor, Michigan  48104-0914
Wayne State UniversityDetroit, Michigan  48202
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
University of ChicagoChicago, Illinois  60637
Central Indiana Cancer CentersIndianapolis, Indiana  46227
The Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
The University Of Texas - M.D. Anderson Cancer CenterHouston, Texas  77030