Clinical trial NCT00909402: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stomach Neoplasms
Esophageal Neoplasms
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Exelixis
First posted: 2009-05-28
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
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
timeFrame: 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 outcomes:
measure: 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
timeFrame: At a minimum on days 1, 8, 15 and 35 of cycle 1, days 1 & 14 for cycle 2 and every 21 days thereafter
measure: 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
timeFrame: During cycle 1
measure: 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
timeFrame: During cycle 2
measure: 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
timeFrame: During cycle 3
measure: The pharmacokinetic parameters that will be assessed include: Cmax (Maximum observed plasma concentration)
timeFrame: During cycles 1, 2 & 3
measure: The pharmacokinetic parameters that will be assessed include: Tmax (Time of maximum observed plasma concentration)
timeFrame: During cycles 1, 2 & 3
measure: The pharmacokinetic parameters that will be assessed include: AUC(TAU) (Area under the concentration-time curve in one dosing interval)
timeFrame: During cycles 1, 2 & 3
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City Of Hope National Medical Center
state: California
city: Los Angeles
country: United States
facility: Usc/Norris Comprehensive Cancer Center
state: California
city: Houston
country: United States
facility: The University Of Texas Md Anderson Cancer Center
state: Texas
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Villejuif
country: France
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: