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WithdrawnNCT00792558Updated Sep 1, 2015

Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced Cancers

A Phase 1 interventional study of BMS-817378 in Advanced Solid Tumors, sponsored by Bristol-Myers Squibb. Withdrawn at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-01.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to find the maximum tolerated dose of BMS-817378 in subjects with advanced cancers

02

Conditions studied

  • Advanced Solid Tumors
03

In context

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Confirmed diagnosis of advanced non-hematologic malignancy. Dose expansion cohort restricted to subjects with advanced or metastatic gastroesophageal cancer, squamous cell cancers of the head and neck, and castration resistant prostate cancer
  • ECOG status 0-1

Exclusion criteria

Exclusion Criteria:

  • WOCBP unwilling/unable to use acceptable contraception methods, and women pregnant or breast feeding
  • Symptomatic brain metastasis
  • Uncontrolled or significant cardiovascular disease
  • History of thromboembolic events or bleeding diathesis in past 6 months
  • Conditions requiring prophylactic anticoagulation or chronic anti-platelet therapy
  • Serious non-healing wounds, ulcers or bone fractures in past 3 months
  • Hemorrhage or bleeding event >= CTCAE grade 3 in past 4 weeks
  • Proteinuria >= 2+ on dipstick or >= 1gm/24 hours
  • Concurrent chemotherapy, hormonal therapy, immunotherapy, radiation therapy or therapy with any other investigational product
  • Concurrent herbal, alternative, food supplements, or strong CYP 3A4 inhibitors or inducers
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Single Arm

    Drug: BMS-817378

Interventions

  • DrugBMS-817378

    Capsule, Oral, Dose escalation to a MTD from a starting dose of 25 mg, once daily, until disease progression/subject discontinuation

06

What researchers measure

Primary outcomes

  1. To establish the MTD of BMS-817378 when administered orally on a daily schedule in subjects with advanced cancers

    Time frame: Within the first 21 days after first dose of BMS-817378

Secondary outcomes

  1. Assess safety and tolerability of multiple doses of BMS-817378 administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors

    Time frame: All time points while subject is on study

  2. Assess the safety and tolerability of co-administration of a CYP substrate cocktail and BMS-817378 given at or below the MTD (dose expansion cohort)

    Time frame: Day 22 +/-2

  3. Characterize the pharmacokinetics of BMS-817378 and its active moiety, BMS-794833

    Time frame: Days 1 and 15

  4. Assess the effects of BMS-817378 and BMS-794833 on blood pressure, heart rate, ECG intervals, and left ventricular ejection fraction

    Time frame: All time points while subject is on study

  5. Describe preliminary evidence for anti-tumor activity of BMS-817378

    Time frame: Every 6 weeks

07

Study locations

3 sites
  • Local Institution
    Adelaide, South Australia 5000, Australia
  • Local Institution
    Nedlands, Western Australia 6009, Australia
  • Local Institution
    Singapore, 169610, Singapore
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00792558
Lead sponsor
Bristol-Myers Squibb
First posted
Nov 18, 2008
Start date
Jan 2009
Primary completion
Nov 2010 (estimated)
Completion
Nov 2010 (estimated)
Last update
Sep 1, 2015

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

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