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AzTrials

CancerPhase 1NCT01653470

Study to Evaluate Safety & Tolerability of BMS-906024 in Combination With Chemotherapy & to Define DLTs & MTD of BMS-906024 in Combination With One of the Following Chemotherapy Regimens; Weekly Paclitaxel, 5FU+Irinotecan or Carboplatin+Paclitaxel in Subjects With Advanced / Metastatic Solid Tumors

A Phase 1 study testing Paclitaxel, 5-Fluorouracil (5FU) and Carboplatin in people with Cancer, run by Bristol-Myers Squibb at 5 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 combination with each of the following three chemotherapy regimens: Paclitaxel, 5FU plus Irinotecan (FOLFIRI), or Carboplatin plus Paclitaxel in subjects with advanced or metastatic solid tumors Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Paclitaxel, 5-Fluorouracil (5FU) and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
141 participants
Where
5 sitesin 3 countries
Study dates
12 Oct 2012to 8 May 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 for whom a chemotherapy regimen is considered appropriate
  • Subjects with non-small cell lung cancer and triple-negative breast cancer are preferred
  • Biopsy accessible tumor (may use archived tumor samples under certain circumstances)
  • Life expectancy of at least 3 months
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Measurable disease

Who cannot join

  • Uncontrolled brain metastases
  • Infection
  • Gastrointestinal (GI) disease with increased risk of diarrhea (e.g. inflammatory bowel disease)
  • Uncontrolled or significant cardiovascular disease
  • Subjects taking medications known to increase risk of Torsades de Pointes

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

Canada3 sites

  • Local Institution

    Edmonton, Alberta, T6G 1Z2

  • Local Institution

    Ottawa, Quebec, K1H 8L6

  • Local Institution

    Toronto, Ontario, M5G 2M9

Other trials in Canada

United States1 site

  • Usc/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

Other trials in United States

Belgium1 site

  • Local Institution

    Brussels, 1000

Other trials in Belgium

About this study

Official title: A Phase Ib Ascending Multi-arm, Dose Escalation Study of BMS-906024 Combined With Several Chemotherapy Regimens in Subjects With Advanced or Metastatic Tumors

The purpose of this study is to identify a safe and tolerable dose of BMS-906024 in combination with each of the following three chemotherapy regimens: Paclitaxel, 5FU plus Irinotecan (FOLFIRI), or Carboplatin plus Paclitaxel in subjects with advanced or metastatic solid tumors

Read the detailed description

DLTs = dose-limiting toxicities

MTD = Maximum tolerated dose

Conditions
Cancer
Being tested
Paclitaxel, 5-Fluorouracil (5FU), Carboplatin, Leucovorin, Irinotecan
Medical subject headings
Neoplasms

What participants receive

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

  • PaclitaxelDrug

    Also called Taxol

  • 5-Fluorouracil (5FU)Drug

    Also called Adrucil, Carac, Efudix, Efudex

  • CarboplatinDrug

    Also called Paraplatin

  • LeucovorinDrug

  • IrinotecanDrug

    Also called Camptosar

  • PaclitaxelDrug

    Also called Taxol

  • BMS-906024Drug

    Also called Notch inhibitor

Study groups in NCT01653470
Study groupRoleWhat they receive
Arm A: Paclitaxel + BMS-906024ExperimentalPaclitaxel 80 mg/m2 solution and BMS-906024 4 mg or 6 mg solution intravenously once weekly continuously until disease progression or unacceptable toxicity
Receives: Drug: Paclitaxel; Drug: BMS-906024
Arm B: FOLFIRI (5FU, Leucovorin, Irinotecan) + BMS-906024Experimental5FU Bolus 400 mg/m2, 5FU Infusion 2400 mg/m2, Irinotecan 180 mg/m2 solution, Leucovorin 400 mg/m2 solution intravenously once every 2 weeks and BMS- 906024 4 mg or 6 mg solution intravenously once weekly continuously until disease progression or unacceptable toxicity
Receives: Drug: 5-Fluorouracil (5FU); Drug: Leucovorin; Drug: Irinotecan; Drug: BMS-906024
Arm C: Carboplatin/Paclitaxel + BMS-906024ExperimentalCarboplatin AUC 6 / Paclitaxel 200 mg/m2 solution once every 3 weeks and BMS-906024 4 mg or 6 mg solution once weekly intravenously continuously until disease progression or unacceptable toxicity
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: BMS-906024
Arm D: Paclitaxel + BMS-906024ExperimentalPaclitaxel 80 mg/m2 solution once weekly and BMS-906024 4 mg or 6 mg solution once every 2 weeks intravenously continuously until disease progression or unacceptable toxicity
Receives: Drug: Paclitaxel; Drug: BMS-906024
Arm F: Carboplatin/Paclitaxcel and BMS-906024ExperimentalCarboplatin AUC 6 / Paclitaxel 200 mg/m2 solution once every 3 weeks and BMS-906024 4 mg or 6 mg solution once every 3 weeks intravenously continuously until disease progression or unacceptable toxicity
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: BMS-906024

What is being measured

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

  1. Safety assessment based on reports of adverse events and clinical laboratory tests as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)

    Measured: Up to 30 days after the last dose of study medication

Secondary outcomes (8)

  1. Maximum observed plasma concentration (Cmax) of BMS-906024 and BMS-911557 (the active metabolite of BMS-906024), Paclitaxel, Irinotecan, SN-38 (the active metabolite of Irinotecan) and Carboplatin

    Duration of first 3 cycles for Arm A: 10 weeks; Arm B: 6 weeks; Arm C: 9 weeks

    Measured: 16 time points up to first 3 cycles

  2. Trough observed plasma concentration (Cmin) of BMS-906024 and BMS-911557 (the active metabolite of BMS-906024), Paclitaxel, Irinotecan, SN-38 (the active metabolite of Irinotecan) and Carboplatin

    Duration of first 3 cycles for Arm A: 10 weeks; Arm B: 6 weeks; Arm C: 9 weeks

    Measured: 16 time points up to first 3 cycles

  3. Time of maximum observed plasma concentration (Tmax) of BMS-906024 and BMS-911557 (the active metabolite of BMS-906024), Paclitaxel, Irinotecan, SN-38 (the active metabolite of Irinotecan) and Carboplatin

    Duration of first 3 cycles for Arm A: 10 weeks; Arm B: 6 weeks; Arm C: 9 weeks

    Measured: 16 time points up to first 3 cycles

  4. Area under the concentration-time curve during a dosing interval of tau [AUC(TAU)] of BMS-906024 and BMS-911557 (the active metabolite of BMS-906024)

    Duration of first 3 cycles for Arm A: 10 weeks; Arm B: 6 weeks; Arm C: 9 weeks

    Measured: 16 time points up to first 3 cycles

  5. Area under the concentration-time curve from time 0 to the time of the last sample collected in the dosing interval [AUC(0-T)] of Paclitaxel, Irinotecan, SN-38 (the active metabolite of Irinotecan) and Carboplatin

    Duration of first 3 cycles for Arm A: 10 weeks; Arm B: 6 weeks; Arm C: 9 weeks

    Measured: 16 time points up to first 3 cycles

  6. Steady-state infusion concentration (Css) of 5-Fluorouracil (5-FU)

    Duration of first 3 cycles for Arm A: 10 weeks; Arm B: 6 weeks; Arm C: 9 weeks

    Measured: 16 time points up to first 3 cycles

  7. Tumor response [as defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria], best overall response (BOR), duration of response, and progression free survival (PFS) will be assessed

    Measured: Every 6 weeks until confirmed disease progression, death or discontinuation for other reasons (whichever comes first) [Approximately 24 months]

  8. Gene mutation status of Notch activation markers as well as other genes of interest in relevant indications, in tumor, and gene expression levels of Notch activation markers, such as but not limited to Hes1, Deltex1, in tumor

    Measured: Baseline (study days -28 to -1)

Timeline

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

  1. First posted31 Jul 2012 (estimated)
  2. Study start12 Oct 2012
  3. Primary completion3 May 2017
  4. Study completion8 May 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
Parallel groups
Masking
None (open label)
Enrolment
141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01653470
Sponsor's protocol ID
CA216-003
Other IDs
2012-003232-23
Status last verified
Jan 2020
First submitted
18 Jul 2012
Last updated
28 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Paclitaxel, 5-Fluorouracil (5FU) and Carboplatin in people with Cancer, run by Bristol-Myers Squibb at 5 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 5 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 28 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 5 sites in Canada, United States, Belgium. 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?

Safety assessment based on reports of adverse events and clinical laboratory tests as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (time frame: Up to 30 days after the last dose of study medication). 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 NCT01653470.

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 28 Jan 2020.

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