A Phase 1 Study of BMS-833923 (XL139) in Subjects With Advanced or Metastatic Cancer

Bristol-Myers Squibb53 enrolled

Overview

The purpose of this study is to determine the safety of BMS-833923 (XL139) in patients with advanced or metastatic cancers and determine the recommended phase 2 dose range and schedule

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

BMS-833923 (XL139)DRUG

Capsules, Oral, 30 mg starting; dose escalation, Once daily, 37 days; additional days if receiving benefit

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Mayo Clinic Rochester

Rochester, Minnesota, United States

Southwest Texas Addiction Research And Tech (Start) Center

San Antonio, Texas, United States

Local Institution

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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

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

Time frame: On average a minimum of 60 days up to 3 years

Secondary Outcomes

Pharmacokinetic parameters of BMS-833923 (XL139) following a single-dose and during daily dosing: Maximum observed plasma concentration (Cmax)

Time frame: Study day 1-7, 36

Pharmacokinetic parameters of BMS-833923 (XL139) following a single-dose and during daily dosing: Time of maximum observed plasma concentration (Tmax)

Time frame: Study day 1-7, 36

Pharmacokinetic parameters of BMS-833923 (XL139) following a single-dose: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-t)] of BMS-833923 (XL139)

Time frame: Study day 1-7

Pharmacokinetic parameters of BMS-833923 (XL139) following a single-dose: Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-833923 (XL139)

Time frame: Study day 1-7

Pharmacokinetic parameters of BMS-833923 (XL139) following a single-dose: Plasma half-life (T-HALF) of BMS-833923 (XL139)

Time frame: Study day 1-7

Pharmacokinetic parameters of BMS-833923 (XL139) during daily dosing: Minimum observed plasma concentration (Cmin) of BMS-833923 (XL139)

Data from ClinicalTrials.gov

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