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

Stomach Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909402
• Other study ID #: CA194-004
• Secondary ID: 2010-018743-33
• Status: Completed
• Phase: Phase 1
• First received: May 22, 2009
• Last updated: June 20, 2013
• Start date: November 2009
• Est. completion date: November 2012

Study information

• Verified date: June 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaKorea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Neoplasms
• Stomach Neoplasms

Intervention

Drug:
• BMS-833923
Capsule, Oral, Starting dose 30 mg, Once daily, continuous until discontinuation from study
• Cisplatin
Vial, intravenous (IV), 80 mg/m² IV, Once every 21 days, 1 day per cycle until discontinuation from study
• Capecitabine
Tablets, Oral, 1000 mg/m², twice a day (BID), 14 days per cycle, until discontinuation from study

Locations

Country	Name	City	State
Canada	Local Institution	Toronto	Ontario
France	Local Institution	Villejuif
Netherlands	Local Institution	Amsterdam
United States	City Of Hope National Medical Center	Duarte	California
United States	The University Of Texas Md Anderson Cancer Center	Houston	Texas
United States	Usc/Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Exelixis

Countries where clinical trial is conducted

United States,  Canada,  France,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At a minimum on days 1, 8, 15 and 35 of cycle 1, days 1 & 14 for cycle 2 and every 21 days thereafter	Yes
Secondary	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		At a minimum on days 1, 8, 15 and 35 of cycle 1, days 1 & 14 for cycle 2 and every 21 days thereafter	Yes
Secondary	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	During cycle 1	No
Secondary	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)	During cycle 2	No
Secondary	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)	During cycle 3	No
Secondary	The pharmacokinetic parameters that will be assessed include: Cmax (Maximum observed plasma concentration)		During cycles 1, 2 & 3	No
Secondary	The pharmacokinetic parameters that will be assessed include: Tmax (Time of maximum observed plasma concentration)		During cycles 1, 2 & 3	No
Secondary	The pharmacokinetic parameters that will be assessed include: AUC(TAU) (Area under the concentration-time curve in one dosing interval)		During cycles 1, 2 & 3	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form