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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Stomach Neoplasms, Esophageal Neoplasms

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Description:

MTD - maximum tolerated dose

Outcome 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

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA194-004

NCT ID:

NCT00909402

Start Date:

November 2009

Completion Date:

November 2012

Related Keywords:

  • Stomach Neoplasms
  • Esophageal Neoplasms
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

Name

Location

USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
City of Hope National Medical CenterLos Angeles, California  91010
The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009