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CancerPhase 1NCT01292655

Study to Evaluate the Safety and Tolerability of IV Doses of BMS-906024 in Subjects With Advanced or Metastatic Solid Tumors

A Phase 1 study testing BMS-906024 in people with Cancer, run by Bristol-Myers Squibb at 8 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to identify a safe and tolerable dose of BMS-906024 in subjects with advanced or metastatic solid tumors who no longer respond to or have relapsed from standard therapies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
BMS-906024
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
8 sitesin 3 countries
Study dates
3 Mar 2011to 22 Jun 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with advanced or metastatic solid tumors (non-hematologic refractory to or relapsed from standard therapies or for which there is no known effective treatment during dose escalation
  • Subjects with squamous non-small cell lung cancer and triple-negative breast cancer or other solid tumor types for which Notch activation has been demonstrated (such as pancreatic, ovarian and melanoma) during dose expansion
  • Biopsy accessible tumor (may be waived under certain circumstances)
  • Life expectancy of at least 3 months
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Adequate organ and bone marrow function

Who cannot join

  • Infection
  • Elevated triglycerides
  • Gastrointestinal (GI) disease with increased risk of diarrhea [e.g. inflammatory bowel disease (IBD)]
  • Taking medications known to increase risk of Torsades De Pointes

Trial locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

United States6 sites

  • Winship Cancer Institute.

    Atlanta, Georgia, 30322

  • Wayne State University

    Detroit, Michigan, 48201

  • The Methodist Hospital Research Institute

    Houston, Texas, 77030

  • University Of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Anthony El-Khoueiry, Md

    Los Angeles, California, 90033

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

Other trials in United States

Australia1 site

  • Local Institution

    Parkville, Victoria, 3050

Other trials in Australia

Canada1 site

  • Local Institution

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-906024 in Subjects With Advanced Solid Tumors

The purpose of this study is to identify a safe and tolerable dose of BMS-906024 in subjects with advanced or metastatic solid tumors who no longer respond to or have relapsed from standard therapies.

Conditions
Cancer
Being tested
BMS-906024
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-906024Drug

    Also called BMS-906024 (Notch inhibitor)

Study groups in NCT01292655
Study groupRoleWhat they receive
Arm A1 (Escalation): BMS-906024ExperimentalBMS-906024 solution intravenously as specified
Receives: Drug: BMS-906024
Arm A2 (Expansion): BMS-906024ExperimentalBMS-906024 solution intravenously as specified
Receives: Drug: BMS-906024
Arm B1 (Escalation): BMS-906024ExperimentalBMS-906024 solution intravenously as specified
Receives: Drug: BMS-906024
Arm B2 (Expansion): BMS-906024ExperimentalBMS-906024 solution intravenously as specified
Receives: Drug: BMS-906024

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects with adverse events as a measure of safety and tolerability

    Measured: Weekly assessments until study discontinuation due to disease progression or unacceptable adverse event as well as an assessment 30 day after treatment discontinuation with an average time on study expected to be <1 year

Secondary outcomes (8)

  1. Tumor assessments using response evaluation criteria in solid tumors (RECIST) v1.1

    Measured: Tumor assessments at least every 8 weeks during treatment period

  2. PD changes from baseline in the expression of Notch pathway-related genes in surrogate tissues (peripheral blood cells) and tumor biopsies

    Measured: PD changes from baseline during the first 4-5 weeks of dosing

  3. PK parameters for BMS-906024 and its metabolite BMS-911557, maximum observed concentration (Cmax)

    Measured: PK at multiple time points during the first 8 weeks of dosing

  4. PK parameters for BMS-906024 and its metabolite BMS-911557, minimum observed concentration (Cmin)

    Measured: PK at multiple time points during the first 8 weeks of dosing

  5. PK parameters for BMS-906024 and its metabolite BMS-911557, time to reach maximum observed concentration (Tmax)

    Measured: PK at multiple time points during the first 8 weeks of dosing

  6. PK parameters for BMS-906024 and its metabolite BMS-911557, terminal phase elimination half-life (T-Half)

    Measured: PK at multiple time points during the first 8 weeks of dosing

  7. PK parameters for BMS-906024 and its metabolite BMS-911557, accumulation index (AI)

    Measured: PK at multiple time points during the first 8 weeks of dosing

  8. PK parameters for BMS-906024 and its metabolite BMS-911557, area under the concentration-time curve (AUC)

    Measured: PK at multiple time points during the first 8 weeks of dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2011 (estimated)
  2. Study start3 Mar 2011
  3. Primary completion22 Jun 2017
  4. Study completion22 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01292655
Sponsor's protocol ID
CA216-001
Status last verified
Jan 2020
First submitted
26 Jan 2011
Last updated
27 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Chan D, Kaplan J, Gordon G, Desai J. Activity of the Gamma Secretase Inhibitor AL101 in Desmoid Tumors: A Case Report of 2 Adult Cases. Curr Oncol. 2021 Sep 21;28(5):3659-3667. doi: 10.3390/curroncol28050312.

    PubMed 34590610

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BMS-906024 in people with Cancer, run by Bristol-Myers Squibb at 8 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with adverse events as a measure of safety and tolerability (time frame: Weekly assessments until study discontinuation due to disease progression or unacceptable adverse event as well as an assessment 30 day after treatment discontinuation with an average time on study expected to be <1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01292655, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.

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