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The purpose of this study is to determine the toxicity and anti-tumor activity of nab-paclitaxel 100mg/m^2 administered weekly in a 4-week cycle as first line therapy to patients with metastatic breast cancer who received taxanes as part of their adjuvant therapy and patients who did not receive taxanes as part of their adjuvant therapy.
This is an open-label, phase II study to determine the toxicity and antitumor activity of ABI-007 100 mg/m2 administered weekly for 3 weeks followed by a rest week (4-week cycle) as first line therapy to patients with metastatic breast cancer in the following 2 cohorts: Patients who have received a taxane as part of their adjuvant therapy, and patients who did not receive a taxane as part of their adjuvant therapy. Patients will be assessed for antitumor response every 8 weeks.
The last subject received study treatment 11DEC2012. The study was terminated on 31 May 2013 via a notification letter to all investigators on 14 May 2013.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABI-007 | Experimental | 100 mg/m^2 ABI-007 was administered by intravenous (IV) infusion over 30 minutes weekly for 3 weeks followed by 1 week rest. Therapy continued until disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABI-007 | Drug | 100 mg/m^2 ABI-007 weekly for 3 weeks followed by 1 week rest |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Based on Investigator and Independent Reviewers | Overall response rate (ORR) is complete response (CR) + partial response (PR). Complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation. Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits | Every 8 weeks from study start until disease progression; Up to 61 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Disease Control | Disease control was defined as stable disease (SD) for ≥ 16 weeks or complete response (CR) or partial response (PR). Response was evaluated by the Investigator and by an independent reviewer using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.0. See Outcome #1 for definitions of CR and PR. RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sasha Smiljanik, MD | Lions Gate Hospital | Principal Investigator |
| Kara Laing, MD | Dr. H. Bliss Murphy Cancer Center | Principal Investigator |
| Wendy Lam, MD | BC Cancer Agency-Burnaby | Principal Investigator |
| Maureen Trudeau, MD | Toronto Sunnybrook Cancer Centre | Principal Investigator |
| Vanessa Bernstein, MD | B.C.C.A. Vancouver Island Center | Principal Investigator |
| Jawaid Younus, MD | London Regional Cancer Centre | Principal Investigator |
| Lawrence Panasci, MD | McGill University | Principal Investigator |
| Guy Cantin, MD | CHA: Saint Sacrement Hospital | Principal Investigator |
| Nicolas Raymond, MD | Hospital de la Cite-de-la Sante-de-Laval | Principal Investigator |
| Robert El-Maraghi, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Cancer Agency-Burnaby | Burnaby | British Columbia | Canada | |||
| Lions Gate Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Brezden B, et al. An open-label, phase II study of weekly nab-paclitaxel as first-line therapy for patients (pts) with metastatic breast cancer (MBC): Safety update. Presented at 2010 ASCO Annual Meeting, June 4-8, 2010, Chicago, IL. Abstract No 1127 C. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Abraxane (Prior Taxane Therapy) | Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest. Therapy continued until disease progression or unacceptable toxicity. |
| FG001 | Abraxane (No Prior Taxane Therapy) | Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest. Therapy continued until disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated Population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Abraxane (Prior Taxane Therapy) | Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest |
| BG001 | Abraxane (No Prior Taxane Therapy) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Based on Investigator and Independent Reviewers | Overall response rate (ORR) is complete response (CR) + partial response (PR). Complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation. Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits | Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Every 8 weeks from study start until disease progression; Up to 61 months |
Any Adverse Event (AE) that started after initial study drug administration through the end of the study or 30 days after the last treatment, whichever was later, were followed until the AE had resolved or stabilized. Upt to 61 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Abraxane (Prior Taxane Therapy) | Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne McClain | Celgene Corporation | 888-260-1599 | clinicaltrialdisclosure@celgene.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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| Every 8 weeks from study start until disease progression; Up to 61 months |
| Progression-free Survival (PFS) | PFS was defined as the time from the first dose of study drug to the start of progression or patient death (any cause), whichever occurred first. Participants who did not have progression or did not die were censored at the last known time the participant was progression free. Participants who initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. | Study start until disease progression, death, or up to data cut off of 31 May 2013; up to 61 months |
| Duration of Response Based on Independent Reviewer Assessment | Duration of response was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Participants who did not have progression or had not died were censored at the last known time the participant was progression free. Participants who had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. CR and PR were defined in outcome #1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST). | Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months |
| Duration of Response Based on Investigator Assessment | Duration of response was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Participants who did not have progression or had not died were censored at the last known time the participant was progression free. Participants who had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Complete response (CR) and partial response (PR) were defined in outcome #1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST). | Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months |
| Patient Survival | Participant survival was the time from the first dose of study drug to participant death from any cause. Participants who did not die were censored at the last known time the participant was alive. | Study start until death, or until data cut-off 31 May 2013; up to 61 months |
| Number of Participants Experiencing Dose Reductions, Interruptions, or Dose Delays of Study Drug | The number of participants with dose reductions, dose interruptions and dose delays that occurred during the treatment period. Dose reductions, interruptions and delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. | Day 1 of study drug to Day 940; data cut off 31 May 2013 |
| Number of Participants With Treatment-Emergent Adverse Events | Count of study participants who had at least one treatment-emergent adverse event (TEAE) defined as any adverse event that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug. The National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) was used to grade AE severity: severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE. Severity grade 5 = death. | Day 1 to Day 940 |
| The Royal Victoria Hospital |
| Principal Investigator |
| Christine Brezden-Masley, MD | Unity Health Toronto | Principal Investigator |
| Andre Robidoux, MD | Centre Hospitalier de l'Universite de Montreal-Hotel-Dieu | Principal Investigator |
| Martin Blackstein, MD | MOUNT SINAI HOSPITAL | Principal Investigator |
| Caroline Hamm, MD | Windsor Regional Cancer Center | Principal Investigator |
| North Vancouver |
| British Columbia |
| Canada |
| B.C.C.A Vancouver Island Center | Victoria | British Columbia | Canada |
| Dr. H. Bliss Murphy Cancer Center | St. John's | Newfoundland and Labrador | Canada |
| The Royal Victoria Hospital | Barrie | Ontario | Canada |
| London Regional Cancer Centre | London | Ontario | Canada |
| Mount Sinai Hospital | Toronto | Ontario | Canada |
| St. Michael's Hospital | Toronto | Ontario | Canada |
| Toronto Synnybrook Cancer Centre | Toronto | Ontario | Canada |
| Windsor Regional Hospital | Windsor | Ontario | Canada |
| Hospital de la Cite-de-la Sante-de-Laval | Laval | Quebec | Canada |
| Centre Hospitalier de l'Universite de Montreal-Hotel-Dieu | Montreal | Quebec | Canada |
| McGill University | Montreal | Quebec | Canada |
| CHA: Saint Sacrement Hospital | Québec | Canada |
| Protocol Deviation |
|
| Participant Discretion |
|
| Other |
|
Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Menopausal Status | Number | participants |
|
| Stage at Primary Diagnosis | Invasive breast cancer stages: Stage I-cancer cells are breaking through to or invading normal surrounding breast tissue. Stage IIa-breast tumor about 2cm and involvement of ancillary lymph nodes. Stage IIb-a larger tumor than earlier phases. Stage IIIa-axillary lymph nodes clumping together. Stage IIIb-spread further to the skin, breast bone or chest wall. Stage IIIc-expanded involvement of lymph nodes. Stage IV-cancer that has spread beyond the breast and nearby lymph nodes to other organs of the body. | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Eastern Cooperative Oncology Group (ECOG) Performance Status is used to assess the progress of disease in a patient, how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. | Number | participants |
|
| Physician Assessment of Peripheral Neuropathy] [2] | The physician assessed sensory neuropathy using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) of "Neurology -- Neuropathy - Sensory". The scale is 0 = normal, 1 = asymptomatic; loss of deep tendon reflexes or paresthesia (including tingling) but not interfering with function, 2 = sensory alteration or paresthesia (including tingling), interfering with activities of daily living (ADL); 3 = Sensory alteration or parasthesia interfering with ADLs; 4 = disabling | Number | participants |
|
|
|
|
| Secondary | Percentage of Participants With Disease Control | Disease control was defined as stable disease (SD) for ≥ 16 weeks or complete response (CR) or partial response (PR). Response was evaluated by the Investigator and by an independent reviewer using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.0. See Outcome #1 for definitions of CR and PR. RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions. | Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Every 8 weeks from study start until disease progression; Up to 61 months |
|
|
|
| Secondary | Progression-free Survival (PFS) | PFS was defined as the time from the first dose of study drug to the start of progression or patient death (any cause), whichever occurred first. Participants who did not have progression or did not die were censored at the last known time the participant was progression free. Participants who initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. | Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug. | Posted | Median | 95% Confidence Interval | months | Study start until disease progression, death, or up to data cut off of 31 May 2013; up to 61 months |
|
|
|
| Secondary | Duration of Response Based on Independent Reviewer Assessment | Duration of response was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Participants who did not have progression or had not died were censored at the last known time the participant was progression free. Participants who had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. CR and PR were defined in outcome #1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST). | Treated Population: The Treated population with a confirmed complete response or partial response. | Posted | Median | 95% Confidence Interval | months | Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months |
|
|
|
| Secondary | Duration of Response Based on Investigator Assessment | Duration of response was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Participants who did not have progression or had not died were censored at the last known time the participant was progression free. Participants who had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Complete response (CR) and partial response (PR) were defined in outcome #1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST). | Treated Population: The Treated population consisted of all enrolled participants that received at least one dose of study drug. | Posted | Median | 95% Confidence Interval | months | Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months |
|
|
|
| Secondary | Patient Survival | Participant survival was the time from the first dose of study drug to participant death from any cause. Participants who did not die were censored at the last known time the participant was alive. | Treated Population: The Treated population consisted of all enrolled participants that received at least one dose of study drug. | Posted | Median | 95% Confidence Interval | months | Study start until death, or until data cut-off 31 May 2013; up to 61 months |
|
|
|
| Secondary | Number of Participants Experiencing Dose Reductions, Interruptions, or Dose Delays of Study Drug | The number of participants with dose reductions, dose interruptions and dose delays that occurred during the treatment period. Dose reductions, interruptions and delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. | Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug. | Posted | Number | participants | Day 1 of study drug to Day 940; data cut off 31 May 2013 |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events | Count of study participants who had at least one treatment-emergent adverse event (TEAE) defined as any adverse event that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug. The National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) was used to grade AE severity: severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE. Severity grade 5 = death. | Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug. | Posted | Number | participants | Day 1 to Day 940 |
|
|
|
| 5 |
| 47 |
| 46 |
| 47 |
| EG001 | Abraxane (No Prior Taxane Therapy) | Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest | 14 | 76 | 75 | 76 |
| Bacteraemia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Histoplasmosis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Performance status decreased | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Depression | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Insomnia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Mood altered | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
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| Breast pain | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
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| Lymphoedema | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
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Institution may publish the results of its findings if a multicenter publication is not forthcoming within 18 months after study completion. Institution shall provide Celgene with a copy of the papers prior to their submission; Celgene shall complete its review within 60 days after receipt. Upon Celgene's request, proposed publication or presentation will be delayed up to 60 additional days to enable Celgene to secure adequate intellectual property protection of patentable material.
| D017437 |
| Skin and Connective Tissue Diseases |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| Patients with at Least One Dose Delay/Not Given |
|
| ≥ 1 Serious Adverse Event |
|
| Treatment related Serious Adverse Event |
|
| ≥1 One Grade 3/4 Adverse Event |
|
| ≥1 One Grade 3 or Higher Adverse Event |
|
| ≥1 AE leading to treatment discontinuation |
|
| ≥1 AE leading to death |
|
| ≥1 AE leading to dose reduction of study drug |
|
| ≥1 AE leading to dose interruption of study drug |
|
| ≥1 AE leading to dose delay of study drug |
|