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A Study of BMS-833923 With Cisplatin and Capecitabine in Inoperable, Metastatic Gastric, Gastroesophageal, or Esophageal Adenocarcinomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00909402
Recruitment Status : Completed
First Posted : May 28, 2009
Last Update Posted : June 21, 2013
Sponsor:
Collaborator:
Exelixis
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE May 22, 2009
First Posted Date  ICMJE May 28, 2009
Last Update Posted Date June 21, 2013
Study Start Date  ICMJE November 2009
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2011)
Use National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) to establish the MTD, Dose Limiting Toxicity (DLT(s)) and safety profile of BMS-833923 administered in combination with Cisplatin and Capecitabine [ Time Frame: At a minimum on days 1, 8, 15 and 35 of cycle 1, days 1 & 14 for cycle 2 and every 21 days thereafter ]
MTD - maximum tolerated dose
Original Primary Outcome Measures  ICMJE
 (submitted: May 27, 2009)
Use NCI CTCAE to establish the MTD, DLT(s) and safety profile of BMS-833923 administered in combination with cisplatin and capecitabine [ Time Frame: At a minimum on days 1, 8, 15 and 35 of cycle 1, days 1 & 14 for cycle 2 and every 21 days thereafter ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2011)
  • To evaluate the safety of single-agent BMS-833923, by assessing the evaluation of number, character and duration of adverse event (AE)/serious adverse event (SAE)s [ Time Frame: At a minimum on days 1, 8, 15 and 35 of cycle 1, days 1 & 14 for cycle 2 and every 21 days thereafter ]
  • Pharmacodynamic effects of BMS-833923 will be measured in tumor biopsy samples taken prior to and during single-agent and combination treatment by evaluation of protein or mRNA of biomarkers of Hedgehog (HH) pathway activation, such as GLI-1 [ Time Frame: During cycle 1 ]
    Glioma-associated oncogene (GLI) mRNA - messenger Ribonucleic acid
  • Pharmacodynamic effects of BMS-833923 will be measured in tumor biopsy samples taken prior to and during single-agent and combination treatment by evaluation of protein or mRNA of biomarkers of Hedgehog (HH) pathway activation, such as GLI-1 [ Time Frame: During cycle 2 ]
    Glioma-associated oncogene (GLI)
  • Pharmacodynamic effects of BMS-833923 will be measured in tumor biopsy samples taken prior to and during single-agent and combination treatment by evaluation of protein or mRNA of biomarkers of Hedgehog (HH) pathway activation, such as GLI-1 [ Time Frame: During cycle 3 ]
    Glioma-associated oncogene (GLI)
  • The pharmacokinetic parameters that will be assessed include: Cmax (Maximum observed plasma concentration) [ Time Frame: During cycles 1, 2 & 3 ]
  • The pharmacokinetic parameters that will be assessed include: Tmax (Time of maximum observed plasma concentration) [ Time Frame: During cycles 1, 2 & 3 ]
  • The pharmacokinetic parameters that will be assessed include: AUC(TAU) (Area under the concentration-time curve in one dosing interval) [ Time Frame: During cycles 1, 2 & 3 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2009)
  • To evaluate the safety and tolerability of single-agent BMS-833923 [ Time Frame: At a minimum on days 1, 8, 15 and 35 of cycle 1, days 1 & 14 for cycle 2 and every 21 days thereafter ]
  • To evaluate Pharmacokinetics and Pharmacodynamics BMS-833923 [ Time Frame: During cycles 1, 2 & 3 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of BMS-833923 With Cisplatin and Capecitabine in Inoperable, Metastatic Gastric, Gastroesophageal, or Esophageal Adenocarcinomas
Official Title  ICMJE Phase 1b Multiple Ascending Dose Study of BMS-833923 (XL139) Administered in Combination With Cisplatin and Capecitabine as First-Line Therapy in Patients With Inoperable, Metastatic Gastric, Gastroesophageal, or Esophageal Adenocarcinomas
Brief Summary The purpose of this study is to determine the maximum tolerated dose (MTD) of BMS-833923 administered in combination with Cisplatin and Capecitabine as first-line therapy in subjects with inoperable metastatic gastric, gastroesophageal or esophageal adenocarcinomas.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stomach Neoplasms
  • Esophageal Neoplasms
Intervention  ICMJE
  • Drug: BMS-833923
    Capsule, Oral, Starting dose 30 mg, Once daily, continuous until discontinuation from study
  • Drug: Cisplatin
    Vial, intravenous (IV), 80 mg/m² IV, Once every 21 days, 1 day per cycle until discontinuation from study
    Other Name: Platinol-AQ
  • Drug: Capecitabine
    Tablets, Oral, 1000 mg/m², twice a day (BID), 14 days per cycle, until discontinuation from study
    Other Name: Xeloda
Study Arms  ICMJE Experimental: All Subjects
Interventions:
  • Drug: BMS-833923
  • Drug: Cisplatin
  • Drug: Capecitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2013)
39
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2009)
30
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Inclusion Criteria:

  • Esophageal, gastric, or gastroesophageal adenocarcinoma that has spread and cannot be treated with surgery. The diagnosis must be confirmed by a trained pathologist.
  • Prior radiation therapy is allowed in certain circumstances - discuss with your doctor.
  • Individuals who have had surgery may be eligible after recovering from the procedure.
  • Individuals who have received chemotherapy for the treatment of their disease within the past 6 months are not eligible. Chemotherapy given more than 6 months ago is permitted.
  • Individuals with spread of their cancer to the brain are permitted in certain circumstances - talk with your doctor.

Exclusion Criteria:

  • Significant heart disease.
  • Women pregnant or breastfeeding.
  • Women able to bear children who are unwilling or unable to use an acceptable method to avoid pregnancy.
  • Uncontrolled medical condition or active infection
  • Inability to swallow pills.
  • Inability to undergo a blood draw, in which a needle is used to obtain blood from a vein in your arm.
  • Individuals receiving another drug not approved by the Food and Drug Administration (FDA) or similar agency in another country.
  • Prisoners or individuals currently receiving treatment for a mental or physical illness as an inpatient in a hospital.
  • Individuals who have experienced pancreatitis, an inflammation of the pancreas, in the past, or who have had a computed axial tomography (CT) scan showing pancreatitis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Netherlands,   United States
Removed Location Countries Korea, Republic of
 
Administrative Information
NCT Number  ICMJE NCT00909402
Other Study ID Numbers  ICMJE CA194-004
2010-018743-33 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Exelixis
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP