Phase 1b/2 Study of Carfilzomib in Relapsed Solid Tumors, Multiple Myeloma, or Lymphoma

Completed · Phase 1/Phase 2

Conditions studied: Ovarian Cancer, Renal Cancer, Non-small Cell Lung Cancer, Small Cell Lung Cancer, Solid Tumors, Multiple Myeloma, Lymphoma

In brief

The primary objectives of this Phase 1b/2 study were as follows: * Phase 1b (Bolus and Infusion): To evaluate the safety and tolerability of carfilzomib in patients with relapsed solid tumors and in patients with relapsed and/or refractory multiple myeloma and in patients with refractory lymphoma. * Phase 2 (Bolus): To evaluate the overall response rate (ORR) after 4 cycles of carfilzomib in patients with relapsed solid tumors.

Key facts

Study ID

NCT00531284

Run by

Amgen

People needed

184

Starts

2007-09-01

Expected to finish

2017-05-22

Last updated by the study team

2017-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Disease related
• Phase 1 Subjects (Bolus and Infusion):
• Solid Tumor:
• Histologically confirmed advanced solid tumor
• 1 to 3 prior treatment regimens
• At least one site of radiographically measurable disease of ≥ 2 cm in the largest dimension by traditional computed tomography (CT) scanning technique or ≥ 1 cm in the largest dimension by spiral CT scanning (per Response Evaluation Criteria in Solid Tumors [RECIST] criteria); or if, in the Principal Investigator's opinion, evaluable disease can be reliably and consistently followed, the subject may be eligible upon approval by the Medical Monitor
• Multiple Myeloma (MM):
• Relapsed and/or refractory multiple myeloma following 2 or more prior treatment regimens.
• Measurable disease as indicated by one or more of the following:
• Serum M-protein ≥ 1 g/dL
• Urine M-protein ≥ 200 mg/24 hr
• Serum Free Light Chain: Involved free light chain (FLC) level ≥ 10 mg/dL provided serum FLC ratio is abnormal
• Lymphoma:
• Histologically or cytologically confirmed lymphoma.
• Patients must have had an initial diagnosis of indolent non-Hodgkin lymphoma (NHL) (including follicular, small lymphocytic, lymphoplasmacytoid, and marginal zone lymphoma), indolent disease that transformed to a more aggressive subtype, as previously described or patients may have mantle cell lymphoma.
• Patients are required to have received prior rituximab (alone or combined with other treatment) and are considered refractory to (defined as no response, or progression within 6 months of completing therapy) or intolerant of continued rituximab.
• Patients may have received up to a maximum of four prior unique chemotherapy regimens, including if not contra-indicated autologous stem-cell transplantation (ASCT).
• For patients to enroll in the expanded dose group for lymphoma, patients must have measurable disease
• Phase 2 Bolus Subjects:
• Histologically confirmed advanced solid tumor diagnosis and:
• Non-small cell lung cancer (NSCLC): Failed at least 1 prior platinum-based chemotherapy regimen but not more than 3 prior therapies for metastatic disease
• Small cell lung cancer (SCLC): Failed 1 to 3 prior chemotherapy regimens
• Ovarian: Failed at least 1 prior platinum-based chemotherapy regimen but not more than 4 therapies for metastatic disease
• Renal: Failed at least 2 prior chemotherapy regimens for metastatic disease
• Other solid tumor types: Failed at least 1 prior chemotherapy regimen for metastatic or relapsed disease and for which standard of care therapy is no longer effective or does not exist

You may not qualify if…

• Disease Related
• Chemotherapy with approved or investigational anticancer therapeutics, including steroid therapy, within 3 weeks prior to first dose or 6 weeks for antibody therapy
• Radiation therapy or immunotherapy within 3 weeks prior to first dose (except for antibody therapy, where 6 weeks is required); localized radiation therapy within 1 week prior to first dose
• Subjects with prior brain metastases are permitted, but must have completed treatment and have no evidence of active central nervous system (CNS) disease for at least 4 weeks prior to first dose
• For lymphoma patients; patients with prior stem cell transplant therapy (autologous SCT within the prior 8 weeks; allogeneic SCT within the prior 16 weeks). Patients with prior allogeneic SCT should not have evidence of moderate-to-severe graft-versus-host disease (GVHD)
• Evidence of CNS lymphoma
• Participation in an investigational therapeutic study within 3 weeks prior to first dose
• Prior treatment with carfilzomib
• Concurrent Conditions
• Major surgery within 3 weeks prior to first dose
• Congestive heart failure (New York Heart Association class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 3 months prior to first dose
• Acute active infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to first dose
• Known or suspected human immunodeficiency virus (HIV) infection or subjects who are HIV seropositive
• Active hepatitis A, B, or C infection
• Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose
• Subjects with pleural effusions requiring routine thoracentesis or ascites requiring routine paracentesis
• Subjects at risk* in whom the required program of oral and intravenous fluid hydration is contraindicated, e.g., due to pre-existing pulmonary, cardiac, or renal impairment
• High risk for Tumor Lysis Syndrome.
• Ethical / Other
• Female subjects who are pregnant or lactating
• Any clinically significant psychiatric or medical condition that in the opinion of the Investigator could interfere with protocol adherence or a subject's ability to give informed consent

Where it is running

• Pinnacle Oncology — Scottsdale, Arizona, United States
• Tower Cancer Research Foundation — Beverly Hills, California, United States
• Northwestern University — Chicago, Illinois, United States
• University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• The Sarah Cannon Research Institute — Nashville, Tennessee, United States
• South Texas Accelerated Research Therapeutics (START) — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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