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A Phase 1 Multiple Ascending Dose Study of BMS-833923 in Subjects With Advanced or Metastatic Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Hedgehog Pathway, Smoothened, Basal Cell Carcinoma (BCC), Basal Cell Nevoid Syndrome (BCNS)

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Trial Information

A Phase 1 Multiple Ascending Dose Study of BMS-833923 in Subjects With Advanced or Metastatic Solid Tumors


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:



- Advanced or metastatic cancer (excluding cancer in the blood) or uncontrolled basal
cell nevoid syndrome or sporadic basal cell carcinoma

- Primary or metastatic tumor site accessible for biopsy

- Ability to swallow capsules

- Subjects with histologically confirmed, advanced stage IIIB or stage IV non-small
cell lung cancer (NSCLC) with a primary histology of squamous carcinoma who have
received prior systemic therapy for advanced NSCLC will be enrolled in Part 3

Exclusion Criteria:

- Uncontrolled brain metastasis

- Significant cardiovascular disease

- Inadequate blood counts

- Inadequate liver, kidney or lung function

- Gastrointestinal disease within last 3 months

- Infection with Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C or
exposure to attenuated active immunizations

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy 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 maximum tolerated dose, a recommended Phase 2 dose range and schedule, and safety profile of BMS-833923

Outcome Description:

Use NCI CTCAE to monitor safety assessments including physical findings, laboratory tests, and radiographic assessments to establish the maximum tolerated dose and recommended Phase 2 dose range and schedule of BMS-833923

Outcome Time Frame:

On average a minimum of 60 days up to 3 years

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:

CA194-002

NCT ID:

NCT00670189

Start Date:

July 2008

Completion Date:

July 2013

Related Keywords:

  • Hedgehog Pathway
  • Smoothened
  • Basal Cell Carcinoma (BCC)
  • Basal Cell Nevoid Syndrome (BCNS)
  • Carcinoma
  • Carcinoma, Basal Cell

Name

Location

Mayo Clinic RochesterRochester, Minnesota  55905
Southwest Texas Addiction Research And Tech (Start) CenterSan Antonio, Texas  78229