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

Multiple Myeloma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821249
• Other study ID #: ARRAY-520-212
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2009
• Est. completion date: March 16, 2016

Study information

• Verified date: October 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 16, 2016
• Est. primary completion date: March 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia, Plasma Cell
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Plasma Cell Leukemia

Intervention

Drug:
• ARRY-520, KSP(Eg5) inhibitor; intravenous
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.
• Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
Part 1: standard of care; Part 2: standard of care; Part 3: standard of care.
• Dexamethasone, steroid; oral
Part 3: standard of care.

Locations

Country	Name	City	State
United States	Emory University, Winship Cancer Institute	Atlanta	Georgia
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	MD Anderson Cancer Center	Houston	Texas
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish the maximum tolerated dose (MTD) of study drug, with and without G-CSF.		Part 1
Primary	Assess the efficacy of the study drug, with and without dexamethasone, in terms of response rate.		Part 2 and Part 3
Primary	Characterize the safety profile of the study drug in combination with dexamethasone in terms of adverse events, clinical laboratory tests and electrocardiograms.		Part 3
Secondary	Characterize the pharmacokinetics of the study drug.		Part 1
Secondary	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.		Part 1
Secondary	Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.		Part 2
Secondary	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.		Part 2 and Part 3
Secondary	Explore potential biomarkers for pharmacodynamics (PD) and for patient selection.		Part 1, Part 2 and Part 3