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NCT00531284 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2017-08-15

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT)

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outcome · POSTED

Phase 2: Percentage of Participants With an Overall Response After 4 Treatment Cycles

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outcome · POSTED

Percentage of Participants With an Overall Response Throughout the Study

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outcome · POSTED

Duration of Response

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outcome · POSTED

Progression-Free Survival

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outcome · POSTED

Time to Progression

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outcome · POSTED

Maximum Observed Plasma Concentration of Carfilzomib

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outcome · POSTED

Time to Maximum Observed Plasma Concentration (Tmax) of Carfilzomib

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outcome · POSTED

Area Under the Plasma Concentration-time Curve From Time Zero to the Last Concentration Measured (AUC0-last) for Carfilzomib

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outcome · POSTED

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Carfilzomib

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outcome · POSTED

Elimination Half-life (t½) of Carfilzomib

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outcome · POSTED

Clearance (CL) of Carfilzomib

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outcome · POSTED

Volume of Distribution at Steady State (Vss) of Carfilzomib

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outcome · POSTED

Mean Residence Time (MRT) Extrapolated to Infinity for Carfilzomib

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: 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 * At least one site of radiographically measurable disease of ≥ 2 cm in the largest dimension by traditional CT scanning technique or ≥ 1 cm in the largest dimension by spiral CT scanning (per 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 Demographic * Males and females ≥ 18 years of age * Life expectancy of more than 3 months * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 Laboratory * Adequate hepatic function, with bilirubin 1.5 times the upper limit of normal (ULN), and alanine aminotransferase (ALT) 3 times ULN * Absolute neutrophil count (ANC) \> 1000/mm³, hemoglobin ≥ 8 gm/dL for solid tumors or 7.0 gm/dL for MM, and platelet count ≥ 100,000/mm³ for solid tumors or ≥ 30,000/mm³ for MM. * Subjects should not have received platelet transfusions for at least 1 week prior to screening * Screening ANC should be independent of granulocyte- and granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support for at least 1 week and of pegylated G-CSF for ≥ 2 weeks * Subjects may receive red blood cell (RBC) transfusions or receive supportive care with erythropoietin or darbepoetin in accordance with institutional guidelines * Calculated or measured creatinine clearance (CrCl) of ≥ 20 mL/minute calculated using the formula of Cockcroft and Gault. Subjects with calculated CrCl \< 20 mL/min may be allowed, only with prior approval by the Medical Monitor. Ethical/Other * Written informed consent in accordance with federal, local, and institutional guidelines * Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 3 days of the first dose and agree to use dual methods of contraception during the study and for 3 months following the last dose of study drug. Post-menopausal females (\> 45 years old and without menses for \> 1 year) and surgically sterilized females are exempt from these requirements. Male subjects must use an effective barrier method of contraception during the study and for 3 months following the last dose if sexually active with a female of childbearing potential. Exclusion Criteria: 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    intervention Names
    1. Drug: Carfilzomib
    label
    Phase 1B Solid Tumors: Carfilzomib 20 mg/m² Bolus
    type
    EXPERIMENTAL
  2. description
    Participants received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    intervention Names
    1. Drug: Carfilzomib
    label
    Phase 1B Solid Tumors: Carfilzomib 20/27 mg/m² Bolus
    type
    EXPERIMENTAL
  3. description
    Participants received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    intervention Names
    1. Drug: Carfilzomib
    label
    Phase 1B Solid Tumors: Carfilzomib 20/36 mg/m² Bolus
    type
    EXPERIMENTAL
  4. description
    Participants received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    intervention Names
    1. Drug: Carfilzomib
    label
    Phase 2 Solid Tumors: Carfilzomib 20/36 mg/m² Bolus
    type
    EXPERIMENTAL
  5. description
    Participants received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    intervention Names
    1. Drug: Carfilzomib
    label
    Phase 1B Solid Tumors: Carfilzomib 36 mg/m²
    type
    EXPERIMENTAL
  6. description
    Participants received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    intervention Names
    1. Drug: Carfilzomib
    label
    Phase 1B Solid Tumors: Carfilzomib 45 mg/m²
    type
    EXPERIMENTAL
  7. description
    Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    intervention Names
    1. Drug: Carfilzomib
    label
    Phase 1B Solid Tumors: Carfilzomib 20/45 mg/m²
    type
    EXPERIMENTAL
  8. description
    Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    intervention Names
    1. Drug: Carfilzomib
    label
    Phase 1B Solid Tumors: Carfilzomib 20/56 mg/m²
    type
    EXPERIMENTAL
  9. description
    Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    intervention Names
    1. Drug: Carfilzomib
    label
    Phase 1B Solid Tumors: Carfilzomib 20/70 mg/m²
    type
    EXPERIMENTAL
  10. description
    Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    intervention Names
    1. Drug: Carfilzomib
    label
    Phase 1b Multiple Myeloma: Carfilzomib 20/36 mg/m²
    type
    EXPERIMENTAL
  11. description
    Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    intervention Names
    1. Drug: Carfilzomib
    label
    Phase 1b Multiple Myeloma: Carfilzomib 20/45 mg/m²
    type
    EXPERIMENTAL
  12. description
    Participants received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    intervention Names
    1. Drug: Carfilzomib
    label
    Phase 1b Multiple Myeloma: Carfilzomib 20/56 mg/m²
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Phase 1B Solid Tumors: Carfilzomib 20 mg/m² Bolus
    2. Phase 1B Solid Tumors: Carfilzomib 20/27 mg/m² Bolus
    3. Phase 1B Solid Tumors: Carfilzomib 20/36 mg/m² Bolus
    4. Phase 1B Solid Tumors: Carfilzomib 20/45 mg/m²
    5. Phase 1B Solid Tumors: Carfilzomib 20/56 mg/m²
    6. Phase 1B Solid Tumors: Carfilzomib 20/70 mg/m²
    7. Phase 1B Solid Tumors: Carfilzomib 36 mg/m²
    8. Phase 1B Solid Tumors: Carfilzomib 45 mg/m²
    9. Phase 1b Lymphoma: Carfilzomib 20/56 mg/m²
    10. Phase 1b Lymphoma: Carfilzomib 20/70 mg/m²
    11. Phase 1b MM: Carfilzomib 20/45 mg/m² + Dexamethasone
    12. Phase 1b MM: Carfilzomib 20/56 mg/m² + Dexamethasone
    description
    Administered by intravenous (IV) bolus (2-10 minute) infusion or 30 minute infusion
    name
    Carfilzomib
    other Names
    1. Kyprolis
    type
    DRUG
  2. arm Group Labels
    1. Phase 1b MM: Carfilzomib 20/45 mg/m² + Dexamethasone
    2. Phase 1b MM: Carfilzomib 20/56 mg/m² + Dexamethasone
    description
    Administered orally or by IV infusion prior to carfilzomib
    name
    Dexamethasone
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
184
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Participants were evaluated for dose-limiting toxicities according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0. A DLT was defined as treatment-related ≥ Grade 2 neuropathy with pain, ≥ Grade 3 non-hematologic toxicity, Grade 4 neutropenia or thrombocytopenia lasting 7 or more days, or thrombocytopenia with bleeding. The maximum tolerated dose (MTD) for each of the 3 populations (solid tumor, multiple myeloma, and lymphoma) was defined as the dose level at which \< 33% of participants experienced a dose-limiting toxicity during the first 28-day cycle.
    measure
    Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT)
    time Frame
    28 days
  2. description
    Overall response is defined as participants with a best overall response of complete response (CR), partial response (PR) or stable disease (SD) after 4 cycles, assessed by the Investigator using tumor measurement and according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target and non-target lesions and no new lesions; PR: Disappearance of all target lesions, persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits and no lesions, or, at least a 30% decrease in the size of target lesions and no progression of existing non-target lesions or any new lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest size since the treatment started, and no progression of existing non-target lesions or any new lesions.
    measure
    Phase 2: Percentage of Participants With an Overall Response After 4 Treatment Cycles
    time Frame
    4 months
secondary Outcomes
  1. description
    Solid tumor participants were evaluated for disease response according to RECIST, Version 1.1. Multiple myeloma participants were evaluated using the International Myeloma Working Group (IMWG) Uniform Response Criteria with the addition of minimal response (MR) based on the European Group for Blood and Marrow Transplant Group (EBMT). Non-Hodgkin lymphoma (NHL) participants were evaluated using the International Workshop NHL criteria. Waldenström macroglobulinemia (WM) participants were evaluated using Criteria from the Sixth International Workshop for WM. Overall response is defined in Outcome Measure 2 for participants with solid tumors. For NHL, overall response is defined as a best overall response of CR or PR. For multiple myeloma and WM, overall response is defined as participants with a best overall response of stringent complete response (sCR), CR, very good partial response (VGPR) or PR.
    measure
    Percentage of Participants With an Overall Response Throughout the Study
    time Frame
    Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
  2. description
    Duration of response is defined as the time from first evidence of a partial response or better (the first observation of PR before confirmation) to disease progression, with deaths owing to causes other than progression censored.
    measure
    Duration of Response
    time Frame
    Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
  3. description
    Progression-free survival (PFS) is the time from start of treatment to disease progression or death (due to any cause), whichever occurred first.
    measure
    Progression-Free Survival
    time Frame
    Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
  4. description
    Time to Progression (TTP) is defined as number of months between start of treatment and first evidence/documentation of disease progression.
    measure
    Time to Progression
    time Frame
    Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
  5. description
    Plasma concentrations of carfilzomib were determined by a validated liquid chromatography tandem mass spectrometry method. Concentration values that were below the lower limit of quantification of 0.1 ng/mL were set to zero. Treatment groups receiving the same dose (e.g. 20 mg/m²) were combined for Day 1 analyses.
    measure
    Maximum Observed Plasma Concentration of Carfilzomib
    time Frame
    Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
  6. measure
    Time to Maximum Observed Plasma Concentration (Tmax) of Carfilzomib
    time Frame
    Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
  7. measure
    Area Under the Plasma Concentration-time Curve From Time Zero to the Last Concentration Measured (AUC0-last) for Carfilzomib
    time Frame
    Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
  8. measure
    Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Carfilzomib
    time Frame
    Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
  9. measure
    Elimination Half-life (t½) of Carfilzomib
    time Frame
    Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
  10. measure
    Clearance (CL) of Carfilzomib
    time Frame
    Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
  11. measure
    Volume of Distribution at Steady State (Vss) of Carfilzomib
    time Frame
    Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
  12. measure
    Mean Residence Time (MRT) Extrapolated to Infinity for Carfilzomib
    time Frame
    Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.
Full study description
brief Summary
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.
Source references
references
  1. citation
    Papadopoulos KP, Siegel DS, Vesole DH, Lee P, Rosen ST, Zojwalla N, Holahan JR, Lee S, Wang Z, Badros A. Phase I study of 30-minute infusion of carfilzomib as single agent or in combination with low-dose dexamethasone in patients with relapsed and/or refractory multiple myeloma. J Clin Oncol. 2015 Mar 1;33(7):732-9. doi: 10.1200/JCO.2013.52.3522. Epub 2014 Sep 15.
    pmid
    25225420
    type
    DERIVED
  2. citation
    Ohshima-Hosoyama S, Davare MA, Hosoyama T, Nelon LD, Keller C. Bortezomib stabilizes NOXA and triggers ROS-associated apoptosis in medulloblastoma. J Neurooncol. 2011 Dec;105(3):475-83. doi: 10.1007/s11060-011-0619-0. Epub 2011 Jun 3.
    pmid
    21633906
    type
    DERIVED
Source notices and limitations
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      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=400&sort=id%3Aasc
      spl effective time
      20250618
      spl set id
      ea66eb30-e665-4693-99a1-a9d3b4bbe2d6

    Preserved source evidence · Not medical advice