NCT00909402

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2009

Typical duration for phase_1

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

June 21, 2013

Status Verified

June 1, 2013

Enrollment Period

3 years

First QC Date

May 22, 2009

Last Update Submit

June 20, 2013

Conditions

Stomach NeoplasmsEsophageal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • 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

  • 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

    During cycle 1

  • 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

    During cycle 2

  • 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

    During cycle 3

  • The pharmacokinetic parameters that will be assessed include: Cmax (Maximum observed plasma concentration)

    During cycles 1, 2 & 3

  • +2 more secondary outcomes

Study Arms (1)

All Subjects

EXPERIMENTAL
Drug: BMS-833923Drug: CisplatinDrug: Capecitabine

Interventions

BMS-833923DRUG

Capsule, Oral, Starting dose 30 mg, Once daily, continuous until discontinuation from study

All Subjects
CisplatinDRUG

Vial, intravenous (IV), 80 mg/m² IV, Once every 21 days, 1 day per cycle until discontinuation from study

Also known as: Platinol-AQ
All Subjects
CapecitabineDRUG

Tablets, Oral, 1000 mg/m², twice a day (BID), 14 days per cycle, until discontinuation from study

Also known as: Xeloda
All Subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

City Of Hope National Medical Center

Duarte, California, 91010-3012, United States

Location

Usc/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

The University Of Texas Md Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Local Institution

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution

Villejuif, 94805, France

Location

Local Institution

Amsterdam, 1105 AZ, Netherlands

Location

Related Links

MeSH Terms

Conditions

Stomach NeoplasmsEsophageal Neoplasms

Interventions

BMS-833923CisplatinCapecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2009

First Posted

May 28, 2009

Study Start

November 1, 2009

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

June 21, 2013

Record last verified: 2013-06

Locations

US(3)CA(1)FR(1)NL(1)