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

Primary Purpose

Stomach Neoplasms, Esophageal Neoplasms

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BMS-833923
Cisplatin
Capecitabine
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • City Of Hope National Medical Center
  • Usc/Norris Comprehensive Cancer Center
  • The University Of Texas Md Anderson Cancer Center
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Subjects

Arm Description

Outcomes

Primary Outcome Measures

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
MTD - maximum tolerated dose

Secondary Outcome Measures

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
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
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
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
Glioma-associated oncogene (GLI)
The pharmacokinetic parameters that will be assessed include: Cmax (Maximum observed plasma concentration)
The pharmacokinetic parameters that will be assessed include: Tmax (Time of maximum observed plasma concentration)
The pharmacokinetic parameters that will be assessed include: AUC(TAU) (Area under the concentration-time curve in one dosing interval)

Full Information

First Posted
May 22, 2009
Last Updated
June 20, 2013
Sponsor
Bristol-Myers Squibb
Collaborators
Exelixis
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1. Study Identification

Unique Protocol Identification Number
NCT00909402
Brief Title
A Study of BMS-833923 With Cisplatin and Capecitabine in Inoperable, Metastatic Gastric, Gastroesophageal, or Esophageal Adenocarcinomas
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Exelixis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms, Esophageal Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All Subjects
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BMS-833923
Intervention Description
Capsule, Oral, Starting dose 30 mg, Once daily, continuous until discontinuation from study
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol-AQ
Intervention Description
Vial, intravenous (IV), 80 mg/m² IV, Once every 21 days, 1 day per cycle until discontinuation from study
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
Tablets, Oral, 1000 mg/m², twice a day (BID), 14 days per cycle, until discontinuation from study
Primary Outcome Measure Information:
Title
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
Description
MTD - maximum tolerated dose
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
Secondary Outcome Measure Information:
Title
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
Title
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
Description
Glioma-associated oncogene (GLI) mRNA - messenger Ribonucleic acid
Time Frame
During cycle 1
Title
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
Description
Glioma-associated oncogene (GLI)
Time Frame
During cycle 2
Title
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
Description
Glioma-associated oncogene (GLI)
Time Frame
During cycle 3
Title
The pharmacokinetic parameters that will be assessed include: Cmax (Maximum observed plasma concentration)
Time Frame
During cycles 1, 2 & 3
Title
The pharmacokinetic parameters that will be assessed include: Tmax (Time of maximum observed plasma concentration)
Time Frame
During cycles 1, 2 & 3
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
City Of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3012
Country
United States
Facility Name
Usc/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
The University Of Texas Md Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Local Institution
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Local Institution
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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