Dasatinib Combo With SMO Inhibitor (BMS-833923)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01218477
First received: October 8, 2010
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

The purpose of the study is to determine the safety, and tolerability of the combination of BMS-833923 plus dasatinib in subjects with chronic phase CML.


Condition Intervention Phase
Leukemia
Drug: Dasatinib
Drug: BMS-833923
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dasatinib (BMS-354825) Combined With SMO Inhibitor (BMS-833923; XL139) in CML With Resistance or Suboptimal Response to a Prior TKI

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The primary endpoint is identification of a recommended Phase 2 dose (RP2D) for BMS-833923 plus dasatinib in subjects with chronic phase CML [ Time Frame: Approximately 120 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The major efficacy endpoint for subjects with CML-CP is rate of CCyR and for subjects with CML-Adv is rate of confirmed MHR [ Time Frame: Approximately 4 years ] [ Designated as safety issue: No ]
  • Other key efficacy endpoints include rates of CHR, MCyR, MMR and CMR, duration of CCyR/MCyR or CHR/MHR and time to progression [ Time Frame: Approximately 4 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics of dasatinib and BMS-833923 will be derived from plasma concentration versus time data. Individual subject PK parameter values will be derived by non-compartmental methods using a validated program [ Time Frame: Approximately 4 years ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: January 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dasatinib + BMS-833923 Drug: Dasatinib
Tablets, Oral, 100 mg - 140 mg once daily, depending on phase, approximately 3 years, depending on response
Other Name: Sprycel
Drug: BMS-833923
Capsules, Oral, 100 mg - 300 mg, depending on cohort) once daily, approximately 3 years, depending on response

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Key Inclusion Criteria:

  • Subjects ≥ 18 years of age
  • Chronic myeloid leukemia (CML) in chronic or advanced phase (including Ph+ALL) with progression/failure during or suboptimal response to imatinib, nilotinib or dasatinib (see protocol for details)
  • Performance Status 0-1 with resolution of toxicity from prior therapy

Key Exclusion Criteria:

  • Known Abl-kinase T315I or T315A mutation
  • Laboratory abnormalities:
  • Uncorrected serum calcium or phosphate below institutional LLN
  • Amylase or lipase Grade ≥1
  • Blood count values Grade ≥3
  • Serious or uncontrolled medical disorder (including infection or cardiovascular disease) or dementia or other serious psychiatric condition
  • Women who are pregnant or breastfeeding or WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy during the entire study period
  • Must be ≥6 months after stem cell transplantation
  • Sexually active fertile men (with partners that are WOCBP) not using effective birth control for duration of study and for at least 3 months following combination treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01218477

Locations
United States, California
University Of California Medical Center
San Francisco, California, United States, 94143
United States, Maryland
Sidney Kimmel Cancer Center At Johns Hopkins
Baltimore, Maryland, United States, 21287
United States, Texas
Ut M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Canada, Ontario
Local Institution
Hamilton, Ontario, Canada, L8N 3Z5
Local Institution
Toronto, Ontario, Canada, M5G 2M9
Finland
Local Institution
Helsinki, Finland, 00290
France
Local Institution
Bordeaux, France, 33076
Local Institution
Poitiers Cedex, France, 86021
Germany
Local Institution
Frankfurt/main, Germany, 60590
Italy
Local Institution
Bologna, Italy, 40138
Local Institution
Orbassano(To), Italy, 10043
United Kingdom
Local Institution
Glasgow, United Kingdom, G12 0YN
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01218477     History of Changes
Other Study ID Numbers: CA180-323, 2010-019480-11
Study First Received: October 8, 2010
Last Updated: June 13, 2013
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Ministry of Health
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Canada: Health Canada

Keywords provided by Bristol-Myers Squibb:
Leukemia
(CML- Chronic Phase and Advanced)

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms
Dasatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014