A Study of BMS-833923 With Cisplatin and Capecitabine in Inoperable, Metastatic Gastric, Gastroesophageal, or Esophageal Adenocarcinomas
This study is ongoing, but not recruiting participants.
Sponsor:
Bristol-Myers Squibb
Collaborator:
Exelixis
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00909402
First received: May 22, 2009
Last updated: July 2, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stomach Neoplasms Esophageal Neoplasms |
Drug: BMS-833923 Drug: Cisplatin Drug: Capecitabine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
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 [ 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 ] [ Designated as safety issue: Yes ]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 [ 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
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 [ Time Frame: During cycle 2 ] [ Designated as safety issue: No ]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 [ Time Frame: During cycle 3 ] [ Designated as safety issue: No ]Glioma-associated oncogene (GLI)
- The pharmacokinetic parameters that will be assessed include: Cmax (Maximum observed plasma concentration) [ Time Frame: During cycles 1, 2 & 3 ] [ Designated as safety issue: No ]
- The pharmacokinetic parameters that will be assessed include: Tmax (Time of maximum observed plasma concentration) [ Time Frame: During cycles 1, 2 & 3 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 36 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 Name: Platinol-AQ
Drug: Capecitabine
Tablets, Oral, 1000 mg/m², twice a day (BID), 14 days per cycle, until discontinuation from study
Other Name: Xeloda
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909402
Locations
| United States, California | |
| City Of Hope National Medical Center | |
| Duarte, California, United States, 91010 | |
| Usc/Norris Comprehensive Cancer Center | |
| Los Angeles, California, United States, 90033 | |
| United States, Texas | |
| The University Of Texas Md Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Canada, Ontario | |
| Local Institution | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| France | |
| Local Institution | |
| Villejuif, France, 94805 | |
| Netherlands | |
| Local Institution | |
| Amsterdam, Netherlands, 1105 AZ | |
Sponsors and Collaborators
Bristol-Myers Squibb
Exelixis
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00909402 History of Changes |
| Other Study ID Numbers: | CA194-004, 2010-018743-33 |
| Study First Received: | May 22, 2009 |
| Last Updated: | July 2, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Neoplasms Esophageal Diseases Esophageal Neoplasms Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Cystic, Mucinous, and Serous Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Head and Neck Neoplasms Stomach Diseases Capecitabine Cisplatin Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 23, 2013