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

NCT00821249

Last updated date
Study Location
Emory University, Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Multiple Myeloma, Plasma Cell Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

(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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

(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.

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Multiple Myeloma, Plasma Cell LeukemiaA Study of ARRY-520 in Patients With Relapsed or Refractory Multiple Myeloma
NCT00821249
  1. Atlanta, Georgia
  2. Detroit, Michigan
  3. Philadelphia, Pennsylvania
  4. Houston, Texas
  5. Seattle, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of ARRY-520 in Patients With Relapsed or Refractory Multiple Myeloma
Official Title  ICMJE Not Provided
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple Myeloma
  • Plasma Cell Leukemia
Intervention  ICMJE
  • Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous
    Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.
  • Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
    Part 1: standard of care; Part 2: standard of care; Part 3: standard of care.
  • Drug: Dexamethasone, steroid; oral
    Part 3: standard of care.
Study Arms  ICMJE
  • Experimental: ARRY-520
    Intervention: Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous
  • Experimental: ARRY-520 + G-CSF support
    Interventions:
    • Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous
    • Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
  • Experimental: ARRY-520 + dexamethasone + G-CSF support
    Interventions:
    • Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous
    • Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
    • Drug: Dexamethasone, steroid; oral
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2016)
55
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2009)
60
Actual Study Completion Date  ICMJE March 16, 2016
Actual Primary Completion Date March 16, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00821249
Other Study ID Numbers  ICMJE ARRAY-520-212
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP