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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00101595
Other study ID # CA180-015
Secondary ID
Status Completed
Phase Phase 2
First received January 12, 2005
Last updated April 7, 2011
Start date January 2005
Est. completion date December 2007

Study information

Verified date April 2011
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this clinical research study is to learn if BMS-354825 will have activity as defined by hematologic responses in subjects with lymphoid blast phase chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia with primary or acquired resistance to imatinib mesylate.


Other known NCT identifiers
  • NCT00110097

Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subjects with Philadelphia chromosome positive (Ph+) (BCR/ABL+) lymphoid blast phase chronic myeloid leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.

- Subjects who are considered to have lymphoid blast phase CML if they meet at least one of the following criteria: *30% lymphoid blasts in peripheral blood or bone marrow. *Extramedullary infiltrates of leukemic cells (other than in spleen or liver) with peripheral blood lymphoid blast morphology.

- ECOG performance status score 0-2.

- Adequate hepatic function defined as: *Total bilirubin less than or equal to 2.0 times the institutional upper limit of normal; *alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 times the institutional upper limit of normal.

- Adequate renal function defined as: *serum creatinine less than or equal to 1.5 times the institutional upper normal limit.

- Men and women, 18 years of age or 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 before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IC/L or equivalent units of HCG) within 72 hours prior to the start of study medication.

Exclusion Criteria:

- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period of at least 1 month before and for at least 3 months after completion of the study medication.

- WOCBP using a prohibited contraceptive method (not applicable).

- Women who are pregnant or breastfeeding.

- Women with a positive pregnancy test on enrollment or prior to study drug administration.

- Men whose sexual partners are WOCBP, who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period and for at least 3 months after completion of study medication.

- Subjects who are eligible and willing to undergo transplantation during the screening period.

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

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

- History of significant bleeding disorder unrelated to CML.

- Concurrent incurable malignancy other than CML.

- Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy.

- Subjects who received any of the following:

- imatinib mesylate within 7 days;

- interferon or cytarabine within 14 days;

- a targeted small molecule anti-cancer agent within 14 days;

- any other investigational or antineoplastic agent other than hydroxyurea or anagrelide within 28 days before starting treatment with BMS-354825.

- Subjects currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes.

- Subjects taking medications that irreversibly inhibit platelet function.

- Prior therapy with 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.

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Dasatinib
Tablets, Oral, 70 mg, twice daily, Until disease progression or untolerable toxicity, switch to the roll-over study or study closure

Locations

Country Name City State
Argentina Local Institution Buenos Aires
Argentina Local Institution Cordoba
Australia Local Institution St. Leonards New South Wales
Austria Local Institution Wien
Belgium Local Institution B-Leuven
Belgium Local Institution Edegem
Belgium Local Institution Yvoir
Brazil Local Institution Campinas
Brazil Local Institution Sao Paulo
Canada Local Institution Montreal Quebec
Canada Local Institution Toronto Ontario
Denmark Local Institution Aarhus
Finland Local Institution Helsinki
France Local Institution Lille
France Local Institution Lyon Cedex 03
France Local Institution Nantes
France Local Institution Paris
France Local Institution Pessac
France Local Institution Poitiers Cedex
France Local Institution Strasbourg Cedex
Germany Local Institution Frankfurt/Main
Germany Local Institution Hamburg
Germany Local Institution Mainz
Germany Local Institution Mannheim
Israel Local Institution Ramat-Gan
Italy Local Institution Bologna
Italy Local Institution Orbassano
Italy Local Institution Roma
Korea, Republic of Local Institution Kyunggi-Do
Korea, Republic of Local Institution Seoul
Netherlands Local Institution Nijmegen
Netherlands Local Institution Rotterdam
Norway Local Institution Trondheim
Peru Local Institution Lima
Sweden Local Institution Gothenburg
Sweden Local Institution Lund
Sweden Local Institution Stockholm
Sweden Local Institution Umea
Sweden Local Institution Uppsala
Switzerland Local Institution Basel
United Kingdom Local Institution Glasgow Central
United Kingdom Local Institution London Greater London
United States Local Institution Anaheim California
United States Local Institution Atlanta Georgia
United States Local Institution Birmingham Alabama
United States Local Institution Boston Massachusetts
United States Local Institution Chicago Illinois
United States Local Institution Hackensack New Jersey
United States Local Institution Houston Texas
United States Local Institution Jacksonville Florida
United States Local Institution Kansas City Kansas
United States Local Institution Los Angeles California
United States Local Institution Nashville Tennessee
United States Local Institution New York New York
United States Local Institution Pittsburgh Pennsylvania
United States Local Institution Portland Oregon
United States Local Institution St. Louis Missouri
United States Local Institution Stanford California
United States Local Institution Tampa Florida
United States Local Institution Vallejo California

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Denmark,  Finland,  France,  Germany,  Israel,  Italy,  Korea, Republic of,  Netherlands,  Norway,  Peru,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (3)

Cortes J, Rousselot P, Kim DW, Ritchie E, Hamerschlak N, Coutre S, Hochhaus A, Guilhot F, Saglio G, Apperley J, Ottmann O, Shah N, Erben P, Branford S, Agarwal P, Gollerkeri A, Baccarani M. Dasatinib induces complete hematologic and cytogenetic responses in patients with imatinib-resistant or -intolerant chronic myeloid leukemia in blast crisis. Blood. 2007 Apr 15;109(8):3207-13. Epub 2006 Dec 21. — View Citation

Ottmann O, Dombret H, Martinelli G, Simonsson B, Guilhot F, Larson RA, Rege-Cambrin G, Radich J, Hochhaus A, Apanovitch AM, Gollerkeri A, Coutre S. Dasatinib induces rapid hematologic and cytogenetic responses in adult patients with Philadelphia chromosome positive acute lymphoblastic leukemia with resistance or intolerance to imatinib: interim results of a phase 2 study. Blood. 2007 Oct 1;110(7):2309-15. Epub 2007 May 11. — View Citation

Porkka K, Koskenvesa P, Lundán T, Rimpiläinen J, Mustjoki S, Smykla R, Wild R, Luo R, Arnan M, Brethon B, Eccersley L, Hjorth-Hansen H, Höglund M, Klamova H, Knutsen H, Parikh S, Raffoux E, Gruber F, Brito-Babapulle F, Dombret H, Duarte RF, Elonen E, Paquette R, Zwaan CM, Lee FY. Dasatinib crosses the blood-brain barrier and is an efficient therapy for central nervous system Philadelphia chromosome-positive leukemia. Blood. 2008 Aug 15;112(4):1005-12. doi: 10.1182/blood-2008-02-140665. Epub 2008 May 13. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Major and overall hematologic response rates throughout the study No
Secondary Durability of hematologic response and time to hematologic response (major and overall) throughout the study No
Secondary Assess cytogenetic and molecular responses throughout the study No
Secondary Measure minor hematologic response rate in the imatinib resistant group throughout the study No
Secondary Explore the role of BCR-ABL mRNA expression and point mutations in the BCR-ABL gene throughout the study No
Secondary Measure the heath-related QOL using FACT-G throughout the study No
Secondary To assess safety and tolerability of dasatinib throughout the study Yes
Secondary Population PK first month No
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