Safety, Efficacy and Pharmacokinetic Study of PRLX 93936 in Patients With Multiple Myeloma

NCT ID: NCT01695590

Last Updated: 2013-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-09-30

Brief Summary

To determine the maximum tolerated dose of, and response to, PRLX 93936 as treatment for patients with relapsed or relapsed/refractory multiple myeloma.

Detailed Description

• To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period, as treatment for patients with relapsed or relapsed/refractory multiple myeloma.
• To establish the dose of PRLX 93936 recommended for future studies.
• To characterize potential toxicities of PRLX 93936.
• To assess the pharmacokinetic profile of PRLX 93936.
• To evaluate response to treatment, time to response (TTR) and duration of response.
• To evaluate time to progression (TTP).

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PRLX 93936

PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period = 1 cycle

Group Type: EXPERIMENTAL

PRLX 93936

Intervention Type: DRUG

PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period = 1 cycle, multiple cycles may be administered

Interventions

PRLX 93936

PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period = 1 cycle, multiple cycles may be administered

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient must have a diagnosis of multiple myeloma and have relapsed or relapsed/refractory disease.
• Patient must have received ≥ 2 prior anti-myeloma regimens including a proteasome inhibitor and/or immunomodulatory agent.
• Patient currently requires systemic therapy.
• Patient has measurable disease.
• Age ≥ 18 years
• Karnofsky performance status ≥ 60%
• ECOG performance 0, 1 or 2
• Life expectancy of at least three months
• Able to take acetaminophen
• Not pregnant
• Patient must have recovered from toxicities incurred as a result of any previous anti-myeloma therapy or recovered to baseline.
• Patients who received an autologous stem cell transplant must be ≥ 3 months post-transplant and all associated toxicities must have resolved to ≤ CTCAE Grade 1.
• QT intervals of QTc ≤ 500 msec

Exclusion Criteria

• POEMS syndrome
• Plasma cell leukemia
• Primary amyloidosis
• Patient has smoldering multiple myeloma or monoclonal gammopathy of unknown significance (MGUS).
• Evidence of spinal cord compression or CNS complication unless controlled by appropriate therapy.
• Patient received chemotherapy or other anti-cancer therapy that may be active against multiple myeloma within 3 weeks prior to the first dose of PRLX 93936.
• Patient received nitrosureas within 6 weeks prior to the first dose.
• Patient received corticosteroids within 2 weeks prior to the first dose.
• Patient received plasmapheresis within 4 weeks prior to the first dose.
• Patient had major surgery within 4 weeks prior to the first dose.
• Patient had an allogeneic stem cell transplant within 6 months before first dose of PRLX 93936 or has evidence of graft versus host disease.
• Patient is taking any therapy concomitantly that may be active against multiple myeloma.
• Patient is currently receiving medication(s) that are principally metabolized via the cytochrome P450 3A4 enzyme pathway.
• Use of any investigational agents within 28 days or 5 half-lives (whichever is shorter) of study treatment.
• Patient has peripheral neuropathy of Grade 3 or greater intensity, or painful Grade 2, as defined by the NCI CTC.
• Patient had a myocardial infarction within 6 months of enrollment or has NYHA Class III or IV heart failure uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
• Abnormal LVEF (< LLN for the institution for a patient of that age) on echocardiogram
• Patient has poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to protocol.
• Patient had a malignancy other than multiple myeloma within 3 years before enrollment, with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in situ prostate cancer.
• Patient's clinical laboratory values meet any of the following criteria within the 7 days prior to Study Day 1:

• Bilirubin > 1.5 times ULN
• AST (SGOT), ALT (SGPT) and Alkaline phosphatase > 2.5 times ULN
• Uncontrolled hypercalcemia (defined as serum calcium > 14 mg/dL)
• Serum creatinine > 2.0 mg/dL or creatinine clearance of < 30 mL/min
• ANC < 1000 cells/mm3 or < 750 cells/mm3 due to >50% marrow involvement
• Platelet count < 50,000 cells/mm3
• Hemoglobin < 8.0 g/dL
• Patient is known to be human immunodeficiency virus (HIV)-positive.
• Patient is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection.
• Patient has an active systemic infection requiring treatment or within 14 days before first dose of PRLX 93936.
• Pregnant or nursing women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prolexys Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Richardson, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Tufts Medical Center

Boston, Massachusetts, United States

Site Status: WITHDRAWN

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Duke University Medical Center

Durham, North Carolina, United States

Site Status: RECRUITING

University of Cincinnati

Cincinnati, Ohio, United States

Site Status: RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Amy Destefanis

Role: primary

amyl_destefanis@dfci.harvard.edu

617-632-6752

Barbara Riff

Role: primary

barbara_riff@med.unc.edu

919-843-7046

Katherine McKernan

Role: backup

katherine_mckernan@med.unc.edu

919-966-4432

Kimberly Oates

Role: primary

kimberly.bartlett@duke.edu

919-668-6524

Sue O'Gara

Role: primary

sue.ogara@uc.edu

513-604-3982

Cindy Farley

Role: primary

cindy.farley@scresearch.net

615-329-7237

Other Identifiers

PRLX93936-0002

Identifier Type: -

Identifier Source: org_study_id