Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Carcinoma

Carcinoma, Hepatocellular

Liver Cirrhosis

Fibrosis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Blood test :carcinoma in cirrhotic patients

Blood test

Natalie Funakoshi

This study will evaluate the usefulness of plasma proteasome levels as a tumor marker of hepatocellular carcinoma (HCC) by studying their variation following curative treatment of HCC. The hypothesis of the study is that plasma proteasome levels will decrease following curative treatment, and that proteasome levels could be used as a marker to detect early recurrence.

HCC occurs in the vast majority of cases in the context of cirrhosis. Cirrhosis is considered a pre-cancerous state, which justifies systematic screening for HCC. Screening currently relies on measurement of alpha-foetoprotein (AFP) levels and ultrasound scans every 4 to 6 months. However, AFP has poor sensitivity as a marker for HCC. We have recently shown that plasma proteasome levels have a higher sensitivity than HCC for detecting HCC in cirrhotic patients, particularly when the tumors are small and can still benefit from curative treatment. The hypothesis of the study is that plasma proteasome levels will decrease following curative treatment, and that proteasome levels could be used as a marker to detect early recurrence. The goal of this study is to determine whether plasma proteasome levels in cirrhotic patients with HCC decrease following curative treatment (radiofrequency, surgical resection, liver transplantation). Plasma proteasome levels will be measured before treatment and 3 months after treatment, then subsequently at 3 month intervals over one year following treatment. The variation of proteasome levels will be compared to AFP levels. The sensitivity of proteasome as a marker to detect tumor recurrence will be evaluated, and compared to AFP.

Evaluation of Proteasome as a Marker of Hepatocellular Carcinoma in Cirrhotic Patients Following Curative Treatment

Evolution of Plasma Proteasome Levels Following Curative Treatment of Hepatocellular Carcinoma in Cirrhotic Patients

Variation of plasma proteasome levels before curative treatment of HCC and 3 months afterwards

Variation of plasma proteasome levels 6, 9 and 12 months following curative treatment for HCC, comparison with AFP levels and results from imaging studies

University Hospital, Montpellier

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Lymphoma

Hematologic Neoplasms

Hodgkin Disease

Waldenstrom Macroglobulinemia

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphosarcoma

Hodgkin Lymphoma

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Dexamethasone acetate

Proteasome Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 115.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.

Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).

Carfilzomib

The purpose of this study is to test the safety and tolerability of carfilzomib at different dose levels on hematological cancers such as multiple myeloma, non-Hodgkin's lymphoma, Hodgkin's disease, or Waldenstrom's macroglobulinemia. Carfilzomib is a proteasome inhibitor, an enzyme responsible for degrading a wide variety of cellular proteins.

Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies

A Phase I Study of the Safety and Pharmacokinetics of Escalating Intravenous Doses of the Proteasome Inhibitor PR-171 in Patients With Hematological Malignancies

A DLT was defined as any of the following occurring in the first 28 days of study participation:

Nonhematologic:

* \> Grade 2 neuropathy with pain
* ≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, or diarrhea)
* ≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy

Hematologic:

* Grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 0.5 × 10ˆ9/L) lasting ≥ 14 days without hematopoietic growth factor support
* Febrile neutropenia (ANC \< 1.0 × 10ˆ9/L with a fever ≥ 38.3°C)
* Grade 4 thrombocytopenia (platelets \< 25.0 × 10ˆ9/L) or thrombocytopenia associated with bleeding.

Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0.

Disease response criteria for NHL were according to the International Working Group Criteria for Non-Hodgkin's Lymphoma. Disease response criteria for Multiple Myeloma were according to the European Group for Blood and Marrow Transplantation (EBMT). Disease response criteria for WM were according to the consensus panel recommendations from the Second International Workshop on Waldenström's Macroglobulinemia. The disease response criteria for Hodgkin's Lymphoma are defined as follows:

* Complete response: total resolution of measurable disease parameters.
* Partial response: a ≥ 50% resolution without the appearance of new disease.
* Stable disease: between \< 50% resolution and ≤ 25% increases in measurable disease parameters without appearance of new disease.
* Progressive disease: an increase of \> 25% in measurable disease parameters.

Best clinical response is the best response observed from the start of study treatment until disease progression or death.

Duration of objective response is defined as the time from the date of first documented assessment of clinical response (confirmed or unconfirmed complete response, partial response, or minimal response) to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment.

Median duration of response was calculated using the Kaplan-Meier method.

Time to progressive disease is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease, plus one day. Participants without tumor progression were censored at the date of their last clinical response assessment.

Median time to progression was calculated using the Kaplan-Meier method.

Progression-free survival is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment. Median progression-free survival was calculated using the Kaplan-Meier method.

Amgen

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

CFZ 1.2 mg/m²

CFZ 2.4 mg/m²

CFZ 4.0 mg/m²

CFZ 6.0 mg/m²

CFZ 8.4 mg/m²

CFZ 11.0 mg/m²

Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

CFZ 15.0 mg/m²

CFZ 20.0 mg/m²

CFZ 27.0 mg/m²

CFZ 20/27 mg/m²

CFZ 20/27 mg/m² + DEX

Total

Dose Escalation (Part 1)

Dose Expansion (Part 2)

Age, Continuous

Sex: Female, Male

African American

Caucasian

Hispanic

Native American

Race/Ethnicity, Customized

Non-Hodgkin's Lymphoma

Waldenstrom's Macroglobulinemia

Hodgkin's Disease

Disease Diagnosis

Study Director

Safety-evaluable: All participants who were enrolled and received at least 1 dose of carfilzomib

Number of Participants With Dose-limiting Toxicities (DLTs)

Participants in the Dose Expansion phase received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.

CFZ 20/27 mg/m² (±DEX)

Participants with available pharmacokinetic (PK) data. Cmax was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.

Maximum Observed Plasma Concentration of Carfilzomib (Cmax)

Complete Response

Partial Response

Minimal Response

Stable Disease/No Change

Progressive Disease

Unknown

Biologic response-evaluable: All participants who received at least 1 cycle of carfilzomib and had both baseline and at least 1 post-baseline disease assessment.

Best Clinical Response to Treatment

Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15, and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.

Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15, and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).

Biologic response-evaluable participants with an objective response

Duration of Response

Time to Progression

Progression-free Survival

Participants with available pharmacokinetic (PK) data. Tmax was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.

Time to Maximum Observed Plasma Concentration of Carfilzomib (Tmax)

Participants with available pharmacokinetic (PK) data. AUClast was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.

Area Under the Concentration-time Curve to Last Measureable Timepoint (AUClast) for Carfilzomib

Participants with available pharmacokinetic (PK) data. AUCinf was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.

Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf) for Carfilzomib

Overall Study

Mouth and Tooth Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Mouth Neoplasms

Laryngeal Neoplasms

Pharyngeal Neoplasms

Mouth Diseases

Stomatognathic Diseases

Otorhinolaryngologic Neoplasms

Laryngeal Diseases

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases

Neoplasms, Squamous Cell

Pharyngeal Diseases

Oral Cancer

Laryngeal Cancer

Lip and Oral Cavity Cancer

Cetuximab

Cisplatin

Bortezomib

Mitogens

Antineoplastic Agents, Immunological

Bortezomib (Velcade, PS-341)

Radiation Therapy

Carter Van Waes, M.D.

Background:

Bortezomib acts on molecules in head and neck cancer cells that are important for the cells growth and survival. The drug may help make the cancer more sensitive to radiation and other chemotherapy drugs.

Cetuximab is a monoclonal antibody that has increased the effectiveness of radiation treatment in patients with head and neck cancer in clinical trials.

Cisplatin has shrunk head and neck cancers and improved treatment response and survival when combined with radiation treatment.

Objectives:

To determine the highest safe dose of bortezomib when combined with cetuximab without or with cisplatin and with radiation in patients with advanced head and neck cancer.

To examine the benefits and side effects of these drug combinations with radiation in patients with advanced head and neck cancer.

Eligibility:

Patients 18 years of age and older with advanced Stage IV head and neck cancer who have not previously had neck radiation.

Design:

Patients will be assigned sequentially to one of two treatment groups: Group A receives bortezomib and cetuximab beginning the week before, and for the duration of, radiation therapy; Group B receives bortezomib, cetuximab and cisplatin beginning the week before, and for the duration of, radiation therapy.

* Cetuximab is given as a 2-hour infusion through a vein (intravenously, IV) for the first dose and then over 1 hour for subsequent weekly doses.
* Bortezomib is given as an injection into a vein over about 5 seconds, twice a week for 2 weeks, followed by a 1-week rest for a total of three 3-week treatment cycles during radiation.
* Cisplatin is given in once a week as a 1-hour IV infusion
* Radiation therapy is given 5 days a week for 7 to 8 weeks.

Post-treatment follow-up:

* Until 2 weeks after treatment ends, patients are followed once a week including a physical examination, review of treatment side effects, and blood tests.
* For 2 months after treatment ends, patients may need to return to the hospital for medical evaluation and supportive care, depending on their condition.
* 8-weeks after treatment ends, patients return for evaluation with a history and physical examination; blood tests; ear, nose and throat evaluation and endoscopy; CT or MRI scan, or both, of the neck and chest; and, if indicated, a PET scan....

Background:

* Advanced squamous cell carcinoma involving the head and neck (SCCHN) has a mortality exceeding 50 percent and significant impact on function and quality of life.
* Treatment of locally advanced SCCHN with anti-Epidermal Growth Factor Receptor (EGFR) antibody cetuximab (Erbitux or C225) or DNA damaging agent cisplatin concurrent with radiation therapy (RT) have shown improvements in response, survival, and organ preservation, of approximately10-20 percent over RT alone. The combination of cetuximab, cisplatin and RT is currently under investigation as the next standard for concurrent chemo-RT for patients with SCCHN.
* Cetuximab inhibits EGFR, which is overexpressed by approximately 90 percent of SCCHN and is associated with decreased patient survival. EGFR contributes to activation of the Mitogen Activated Protein Kinase (MAPK) and Signal Transduction and Activating Transcription Factor (STAT3) pathways, which promote induction of genes involved in cell proliferation and survival.
* Recently, the Nuclear Factor-kappaB (NF-kB) pathway has been shown to be an independent pathway important for altered expression of prosurvival genes, the malignant phenotype, and prognosis.
* Proteasome inhibitor bortezomib (Velcade, PS-341) can inhibit NF-kB and target genes, as well as increase expression of tumor suppressor genes such as p53 in SCCHN. Bortezomib in combination with RT, cetuximab or cisplatin induces greater cytotoxic effects in cancer cells than these treatments individually in preclinical studies.
* In this phase I trial we will determine the feasibility of administering bortezomib concurrently with cetuximab and RT, and cetuximab, cisplatin and RT. We hypothesize that bortezomib can be given with these combinations with an acceptable toxicity profile and a maximum tolerated dose (MTD) that demonstrates clinical activity and effects on NF-kB, MAPK and STAT3 pathway signaling and apoptosis in SCCHN.

Specific Objectives:

Primary Objectives

-To evaluate the feasibility and toxicities of combining the proteasome inhibitor bortezomib with cetuximab, or cetuximab and cisplatin concurrent with radiation for therapy of patients with advanced squamous cell carcinoma of the head and neck (SCCHN), and to identify the MTD for bortezomib for further clinical phase 2 development.

Secondary Objectives

-To evaluate the objective response rate, progression-free survival and overall survival with the above regimen.

To determine the effects of bortezomib with cetuximab, or bortezomib, cetuximab with cisplatin to inhibit activation of the NF-kB, EGFR, MAPK, and STAT3 signal pathways, expression of pro-survival and pro-angiogenesis genes regulated by these pathways, and effects on proliferation, apoptosis and angiogenesis.

Eligibility:

-Patients with advanced Stage IV SCCHN, without history prior neck radiation, for whom concurrent chemo-RT is an option.

Design:

* All patients will receive standard RT to a total dose of 70 Gy, in 2 Gy/day fractions, 5 days/week, concurrent with either bortezomib and cetuximab, or bortezomib, cetuximab and cisplatin.
* Bortezomib will be given following a dose escalation schema (3 dose levels of 0.7, 1 and 1.3 mg/m2/dose) IV twice weekly for the first two weeks of three 21-day cycles which each include a 1 week break, starting the week prior to RT initiation and for a total of 7-8 weeks.
* In group A, patients with receive bortezomib, cetuximab and RT, and in group B, bortezomib, cetuximab, cisplatin and RT.
* Previously established MTDs will be used for weekly administration of cetuximab (400mg/m2 initially and then 250 mg/m(2) IV weekly), and cisplatin (30mg/m(2) IV weekly).
* Cetuximab or cetuximab and cisplatin will be given with the first dose of bortezomib the week prior to RT and continue weekly during RT (7-8 weekly doses). Drug therapy will not be given after RT completion.
* Groups A will accrue before group B, to identify the MTD for the combination of bortezomib, cetuximab and RT, and then bortezomib, cetuximab, cisplatin and RT, for expansion and phase 2 development.
* Serum and blood will be collected for study of potential proteomic and genetic markers of drug sensitivity and effects, and tumor response and recurrence, within 2 weeks pretreatment and days 5, 12 of bortezomib cycle 1, and day 12 of cycles 2 and 3. Serum will be collected thereafter every 3 months up to 24 months.
* Optional tumor and/or skin biopsies will be performed within 2 weeks before start of treatment and on day 5 of the first week during treatment with drugs alone, and on day 12 after start of RT for correlative studies of the combined effects of bortezomib with cetuximab, or bortezomib cetuximab and cisplatin on signal pathway activation, apoptosis and other markers, without and with RT. (Details of correlative studies). Patients will be evaluated by CT and FDG-PET pre-treatment and for response 8 weeks post-RT using WHO RECIST criteria.
* The study design and sample size is Phase 1, 3-6 patients per dose level to establish the MTD. An additional 6-10 patients (in each group) will be treated at the MTD in order further assess toxicity, response and molecular correlatives. The anticipated sample size is between 6 and 46.

Radiation Therapy and Bortezomib and Cetuximab With or Without Cisplatin to Treat Head and Neck Cancer

Phase I Study of Bortezomib and Cetuximab Without or With Cisplatin in Combination With Radiation Therapy for Advanced Head and Neck Cancer

National Cancer Institute (NCI)

Participants received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.

Carfilzomib dose levels ranged from 11 to 27 mg/m² for 2- to 10-minute infusions and 36 to 56 mg/m² for 30-minute infusions. Carfilzomib doses were administered on days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. Dose level reduction to a minimum dose of 11 mg/m² for toxicity was permitted.

This is a multi-center, open-label, Phase 2 study of carfilzomib to monitor the safety and efficacy of long-term or continuing carfilzomib therapy for patients who previously completed a primary carfilzomib treatment study.

A Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols

An Open-Label, Single-Arm, Phase 2 Study of Extended Carfilzomib Therapy in Subjects Previously Enrolled in Carfilzomib Treatment Protocols

Participants with peripheral neuropathy or peripheral neuropathy-related adverse events, including hypoaesthesia, paraesthesia, dysaesthesia, and neuropathic pain.

Adverse events (AEs) were assigned a severity grade using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading scale version 3.0.

Per protocol, adverse events were collected if they led to dose modification or dose discontinuation, were grade ≥ 3 or serious, or were events of peripheral neuropathy (any grade).

A serious AE is one that met one or more of the following criteria:

* Death
* Life threatening
* Required inpatient hospitalization or prolongation of an existing hospitalization
* Resulted in persistent or significant disability/incapacity
* A congenital anomaly/birth defect in the offspring of an exposed subject
* Important medical events that, based upon appropriate medical judgment, jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes above.

Since participants were only followed up to 30 days after administration of last dose of study drug per protocol, Kaplan-Meier estimates of overall survival were not calculated. The number of participants who died within 30 days after administration of last dose of study drug is reported.

Progression-free survival (PFS) was defined as the time between the start of treatment and first evidence of documented disease progression or death (due to any cause), whichever occurred first.

Disease progression was determined by the local investigator for regimens with the same baseline using the International Uniform Response Criteria (IMWG-URC) for participants with multiple myeloma and Response Evaluation Criteria in Solid Tumors (RECIST) criteria for solid tumor participants.

PFS was re-calculated whenever the baseline was reset due to addition of new anti-cancer therapy or increase of carfilzomib dose/frequency.

Time to progression (TTP) was defined as the time between start of treatment to the first documentation of disease progression. TTP was re-calculated whenever the baseline was reset due to addition of new anti-cancer therapy or increase of carfilzomib dose/frequency.

The protocol indicated that AEs leading to dose modification, dose discontinuation, CTCAE grade 3+, serious AEs and all-grade peripheral neuropathy AEs were collected in the study.

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.

Solid Tumors

Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.

Age, Customized

A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care, unable to carry out any work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.

Eastern Cooperative Oncology Group (ECOG) Performance Status

All participants who received at least 1 dose of carfilzomib after enrollment in PX-171-010.

Number of Participants With Peripheral Neuropathy

Any adverse event

Adverse event ≥ grade 3

Serious adverse events

Fatal adverse events

AE leading to discontinuation of carfilzomib

Number of Participants With Adverse Events

Overall Survival

Enrolled participants excluding those with no postbaseline endpoint data subsequent to at least 1 dose of the study drug on the PX-171-010 protocol and participants who lacked baseline data for those analyses that required baseline data. Only participants with regimens that continued from the initial study without baseline being reset are included.

Enrolled participants excluding those with no postbaseline endpoint data subsequent to at least 1 dose of the study drug on the PX-171-010 protocol and participants who lacked baseline data for those analyses that required baseline data Only participants with regimens that continued from the initial study without baseline being reset are included.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Proteasome as a Marker of Hepatocellular Carcinoma in Cirrhotic Patients Following Curative Treatment	NCT01492127	Hepatocellular ... Cirrhosis	Blood test	18 Years -	University Hospital, Montpellier
Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies	NCT00150462	Waldenstrom's M... Non-Hodgkin's L... Hodgkin's Disea... Multiple Myelom...	Carfilzomib Dexamethasone	18 Years -	Amgen
Radiation Therapy and Bortezomib and Cetuximab With or Without Cisplatin to Treat Head and Neck Cancer	NCT01445405	Carcinoma, Squa... Head and Neck C... Oral Cancer Laryngeal Cance... Pharyngeal Canc...	Bortezomib (Vel... Cetuximab Cisplatin Radiation Thera...	18 Years - 90 Years	National Institutes of Health Clinical Center (CC)
A Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols	NCT00884312	Multiple Myelom... Solid Tumors	Carfilzomib	18 Years -	Amgen
Study of the Safety and Pharmacokinetics of Carfilzomib in Patients With Relapsed and Refractory Multiple Myeloma and Varying Degrees of Renal Function	NCT00721734	Multiple Myelom... Renal Insuffici...	Carfilzomib	18 Years -	Amgen

Spots Global Cancer Trial Database for proteasome

Every month we try and update this database with for proteasome cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for proteasome

Every month we try and update this database with for proteasome cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for proteasome cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.