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A Study of ARRY-520 in Patients With Relapsed or Refractory Multiple Myeloma

Primary Purpose

Multiple Myeloma, Plasma Cell Leukemia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ARRY-520, KSP(Eg5) inhibitor; intravenous

Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous

Dexamethasone, steroid; oral

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring plasma cell dyscrasia, plasmacytoma, kinesin spindle protein, anti-mitotic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria (Part 3):

Patients should have received at least two prior treatment regimens.
Confirmed refractory MM (measurable disease) or PCL. Patients must be refractory to treatment with both lenalidomide/dexamethasone and bortezomib/dexamethasone (or to treatment with bortezomib/lenalidomide/dexamethasone), defined as documented progressive disease on therapy or within 60 days of completing treatment with these regimens.
Previously received adequate alkylator therapy.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Adequate hematology laboratory values without transfusion support within 2 weeks of screening.
Adequate liver and renal function.
Additional criteria exist.

Key Exclusion Criteria (Part 3):

Primary amyloidosis.
Concomitant malignancies or previous malignancies with less than a 3-year disease free interval at the time of enrollment (patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or Stage A low grade prostate cancer may enroll irrespective of the time of diagnosis).
Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to first dose of study drug.
Cytotoxic therapy or monoclonal antibodies within 21 days prior to first dose of study drug.
Radiotherapy within 21 days prior to first dose of study drug (if the radiation portal covered ≤ 5% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy).
Corticosteroid doses > 10 mg/day of prednisone or equivalent within 2 weeks prior to first dose of study drug.
Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or active hepatitis C.
Additional criteria exist.

Sites / Locations

Emory University, Winship Cancer Institute
Karmanos Cancer Institute
Fox Chase Cancer Center
MD Anderson Cancer Center
Fred Hutchinson Cancer Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

ARRY-520

ARRY-520 + G-CSF support

ARRY-520 + dexamethasone + G-CSF support

Arm Description

Outcomes

Primary Outcome Measures

Establish the maximum tolerated dose (MTD) of study drug, with and without G-CSF.

Assess the efficacy of the study drug, with and without dexamethasone, in terms of response rate.

Characterize the safety profile of the study drug in combination with dexamethasone in terms of adverse events, clinical laboratory tests and electrocardiograms.

Secondary Outcome Measures

Characterize the pharmacokinetics of the study drug.

Assess the efficacy of the study drug in terms of response rate, duration of response, progression-free survival, treatment-free survival and time to next treatment.

Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.

Assess the efficacy of the study drug, with and without dexamethasone, in terms of duration of response, progression-free survival, treatment-free survival, time to next treatment and overall survival.

Explore potential biomarkers for pharmacodynamics (PD) and for patient selection.

Full Information

NCT ID

NCT00821249

First Posted

January 9, 2009

Last Updated

October 8, 2020

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00821249

Brief Title

A Study of ARRY-520 in Patients With Relapsed or Refractory Multiple Myeloma

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

January 2009 (Actual)

Primary Completion Date

March 16, 2016 (Actual)

Study Completion Date

March 16, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a 2-phase study during which patients with relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL), who have already received at least two previous treatments, will receive investigational study drug ARRY-520. The study has 3 parts. In the first part of the study, Phase 1, patients will receive increasing doses of study drug, with or without granulocyte-colony stimulating factor (G-CSF) support, in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 30 patients from the US will be enrolled in Part 1 (Active, not recruiting). In the second part of the study, Phase 2, patients will receive the best dose of study drug determined from the first part of the study and will be followed to evaluate what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 30 patients from the US will be enrolled in Part 2 (Active, not recruiting). In the third part of the study, Phase 2 with Dexamethasone, patients will receive the best dose of the study drug determined from the first part of the study, in combination with dexamethasone, and will be followed to evaluate what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 50 patients from the US will be enrolled in Part 3 (Active, not recruiting).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma, Plasma Cell Leukemia

Keywords

plasma cell dyscrasia, plasmacytoma, kinesin spindle protein, anti-mitotic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ARRY-520

Arm Type

Experimental

Arm Title

ARRY-520 + G-CSF support

Arm Type

Experimental

Arm Title

ARRY-520 + dexamethasone + G-CSF support

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

ARRY-520, KSP(Eg5) inhibitor; intravenous

Intervention Description

Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.

Intervention Type

Drug

Intervention Name(s)

Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous

Intervention Description

Part 1: standard of care; Part 2: standard of care; Part 3: standard of care.

Intervention Type

Drug

Intervention Name(s)

Dexamethasone, steroid; oral

Intervention Description

Part 3: standard of care.

Primary Outcome Measure Information:

Title

Establish the maximum tolerated dose (MTD) of study drug, with and without G-CSF.

Time Frame

Part 1

Title

Assess the efficacy of the study drug, with and without dexamethasone, in terms of response rate.

Time Frame

Part 2 and Part 3

Title

Characterize the safety profile of the study drug in combination with dexamethasone in terms of adverse events, clinical laboratory tests and electrocardiograms.

Time Frame

Part 3

Secondary Outcome Measure Information:

Title

Characterize the pharmacokinetics of the study drug.

Time Frame

Part 1

Title

Assess the efficacy of the study drug in terms of response rate, duration of response, progression-free survival, treatment-free survival and time to next treatment.

Time Frame

Part 1

Title

Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.

Time Frame

Part 2

Title

Time Frame

Part 2 and Part 3

Title

Explore potential biomarkers for pharmacodynamics (PD) and for patient selection.

Time Frame

Part 1, Part 2 and Part 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria (Part 3): Patients should have received at least two prior treatment regimens. Confirmed refractory MM (measurable disease) or PCL. Patients must be refractory to treatment with both lenalidomide/dexamethasone and bortezomib/dexamethasone (or to treatment with bortezomib/lenalidomide/dexamethasone), defined as documented progressive disease on therapy or within 60 days of completing treatment with these regimens. Previously received adequate alkylator therapy. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. Adequate hematology laboratory values without transfusion support within 2 weeks of screening. Adequate liver and renal function. Additional criteria exist. Key Exclusion Criteria (Part 3): Primary amyloidosis. Concomitant malignancies or previous malignancies with less than a 3-year disease free interval at the time of enrollment (patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or Stage A low grade prostate cancer may enroll irrespective of the time of diagnosis). Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to first dose of study drug. Cytotoxic therapy or monoclonal antibodies within 21 days prior to first dose of study drug. Radiotherapy within 21 days prior to first dose of study drug (if the radiation portal covered ≤ 5% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy). Corticosteroid doses > 10 mg/day of prednisone or equivalent within 2 weeks prior to first dose of study drug. Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or active hepatitis C. Additional criteria exist.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Emory University, Winship Cancer Institute

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Karmanos Cancer Institute

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Fox Chase Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Fred Hutchinson Cancer Research Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Citations:

PubMed Identifier

28817190

Citation

Shah JJ, Kaufman JL, Zonder JA, Cohen AD, Bensinger WI, Hilder BW, Rush SA, Walker DH, Tunquist BJ, Litwiler KS, Ptaszynski M, Orlowski RZ, Lonial S. A Phase 1 and 2 study of Filanesib alone and in combination with low-dose dexamethasone in relapsed/refractory multiple myeloma. Cancer. 2017 Dec 1;123(23):4617-4630. doi: 10.1002/cncr.30892. Epub 2017 Aug 17.

Results Reference

derived

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A Study of ARRY-520 in Patients With Relapsed or Refractory Multiple Myeloma

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