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Completed

NCT Number: NCT01413906

Phase 1 Multiple Ascending Dose Study of BMS-833923 (XL139) in Subjects With Solid Tumors

The purpose of this study is to evaluate the tolerability and safety profile of BMS-833923 (XL139) when orally administered on a once daily schedule.

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Key information

Conditions

Cancer Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Kashiwa-shi, Chiba, 2778577, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with advanced or metastatic solid tumors refractory to, or relapsed from, standard therapies or for which there is no known effective treatment
  • Men and woman, 20 years of age and above

Exclusion criteria

  • Subjects with symptomatic brain metastasis or active brain metastasis requiring treatments
  • Inability to swallow oral medication
  • Uncontrolled or significant cardiovascular disease
  • Inadequate bone marrow function
  • Inadequate hepatic function
  • Inadequate renal function
  • Pancreatitis

Treatment and study plan

BMS-833923 (XL139)

Drug

Capsule, Oral, 150 mg, 300 mg, or 450 mg,Once daily, Until progression of disease, unacceptable toxicity, withdrawal of subject's consent or meeting other discontinuation criteria

Other names: (XL139)

Primary outcomes

  1. Incidence of Dose Limiting Toxicity (DLT) and observed adverse events

    Time frame: Within the first 28 days of treatment

  2. Incidence of Dose Limiting Toxicity (DLT) and observed adverse events

    Time frame: Up to 90 days additional treatment period plus 60 days of follow-up

Secondary outcomes

  1. The number of subjects experienced DLT

    Time frame: Within the first 28 days

  2. Maximum observed concentration (Cmax) of BMS-833923 (XL139)

    Time frame: Day1 and Day 29

  3. Trough observed concentration (Cmin) of BMS-833923 (XL139)

    Time frame: Day1 and Day 29

  4. Time of maximum observed concentration (Tmax) of BMS-833923 (XL139)

    Time frame: Day1 and Day 29

  5. Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-833923 (XL139)

    Time frame: Day1 and Day 29

  6. Effective half-life (T-half,eff) of BMS-833923 (XL139)

    Time frame: Day1 and Day 29

  7. Accumulation index (AI) of BMS-833923 (XL139)

    Time frame: Day1 and Day 29

  8. Best overall response assessed according to Response evaluation criteria in solid tumors (RECIST) v1.1 criteria

    Time frame: Up to120 days of treatment period

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 10, 2011
Registry last updated
Jun 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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