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

June 20, 2013 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution
  • France
      • Villejuif, France, 94805
        • Local Institution
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Local Institution
  • United States
    • California
      • Duarte, California, United States, 91010-3012
        • City of Hope National Medical Center
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center
    • Texas
      • Houston, Texas, United States, 77030-4009
        • The University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All Subjects
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 Names:
  • Platinol-AQ
Drug: Capecitabine
Tablets, Oral, 1000 mg/m², twice a day (BID), 14 days per cycle, until discontinuation from study
Other Names:
  • Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At a minimum on days 1, 8, 15 and 35 of cycle 1, days 1 & 14 for cycle 2 and every 21 days thereafter

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
During cycle 1
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)
During cycle 2
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)
During cycle 3
The pharmacokinetic parameters that will be assessed include: Cmax (Maximum observed plasma concentration)
Time Frame: During cycles 1, 2 & 3
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
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
During cycles 1, 2 & 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Exelixis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

May 22, 2009

First Submitted That Met QC Criteria

May 27, 2009

First Posted (Estimate)

May 28, 2009

Study Record Updates

Last Update Posted (Estimate)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 20, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA194-004
  • 2010-018743-33 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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