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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-02101 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| LUN0067 | Other Identifier | OnCore | |
| IRB-30982 | Other Identifier | Stanford University IRB |
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| Name | Class |
|---|---|
| Nektar Therapeutics | INDUSTRY |
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This phase 2 trial evaluates how well pegylated irinotecan (NKTR-102) works in treating patients with non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), or breast cancer (mBC) that has spread to the brain and does not respond to treatment. Pegylated irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Objective:
For cohort A and Cohort C, to determine the central nervous system (CNS) disease control rate (number of patients with stable disease or partial response or complete response / total number of treated patients) at 12 weeks following treatment with etirinotecan pegol in patients with advanced non-small cell lung cancer (NSCLC) or with metastatic brain cancer (mBC) with refractory brain metastases
Secondary Objectives:
Cohorts A and C:
Cohort B:
• To observe CNS and systemic disease control in small cell lung cancer (SCLC)
Cohorts A, B and C:
• To determine the safety profile of etirinotecan pegol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A - Pegylated Irinotecan to treat NSCLC | Experimental | Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. |
|
| Cohort B - Pegylated Irinotecan to treat SCLC | Experimental | Patients with small cell lung carinoma (SCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. |
|
| Cohort C - Pegylated Irinotecan to treat mBC | Experimental | Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated Irinotecan | Drug | Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Central Nervous System (CNS) Disease Control Rate (Cohort A and C) | Central nervous system (CNS) disease control (DC) is defined as a complete response (CR); partial response (PR); or stable disease (SD). The outcome is reported as the number and percentage of participants who achieve DC, a number without dispersion. Response criteria are as follows. Note that any lesion less than 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.
| At 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Disease Control Rate (Cohort A and C) | Overall disease control (DC) rate is defined as the sum in a cohort of the numbers of participants achieving complete response (CR); partial response (PR); or stable disease (SD), divided by the number of patients in that cohort. For this outcome, "overall" means all body systems, not just the central nervous system (CNS). The outcome is reported as DC rate, a number without dispersion. Response criteria are as follows. Note that any lesion <10 mm in longest diameter (LD) is considered unchanged unless there is a ≥3 mm change in the sum of the LDs.
|
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Inclusion Criteria:
Advanced or refractory cancer, consisting of
Metastatic breast cancer (mBC) for which single-agent cytotoxic chemotherapy is indicated. OR
Histologically-proven metastatic lung cancer:
Prior chemotherapy (at least one of the following):
Prior chemotherapy, including other investigational therapy, has been completed prior to initiation of study treatment, according to the following:
The following measurement criteria are required, as visualized by contrast-enhanced MRI with slice thickness of ≤ 1.5 mm, unless absence of contrast or thicker slices is specifically authorized by Protocol Director. Measurements do not include tumor edema.
Adequate organ function as evidenced by:
Exclusion Criteria:
Previous treatment with a camptothecin derivative (eg, irinotecan, topotecan, and investigational agents including but not limited to exatecan, rubitecan, gimatecan, karenitecin, SN38 investigational agents, EZN 2208, SN 2310, and AR 67) is not allowed
Patients may not have a known history of leptomeningeal disease, as diagnosed by positive CSF cytology, unless prospective permission for enrollment is granted from the sponsor and the PI
Patients may not have had major surgery or radiotherapy (therapeutic and/or palliative) within 14 days prior to initiation of study treatment, including CNS-directed radiation therapy. Minor procedures, such as tumor biopsy, thoracentesis, or intravenous catheter placement are allowed with no waiting period
Patients may not have the following co morbid disease or concurrent illness:
Patients may not have a known allergy or hypersensitivity to any of the components of the investigational therapy, including polyethylene glycol (PEG) or topoisomerase inhibitors
Patients may not be receiving the following medications at the time of first dose of investigational drug:
Pregnant or nursing patients will be excluded from the study
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| Name | Affiliation | Role |
|---|---|---|
| Joel Neal | Stanford University Hospitals and Clinics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A - Pegylated Irinotecan to Treat NSCLC | Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan NKTR 102 IV over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2016 |
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|
| At 12 weeks |
| Overall Response Rate (Cohort A and C) | Overall response by subject (OR) is defined as the lower assessment between the central nervous system response and the systemic response. Response is defined as either complete response (CR) or partial response (PR). The outcome is reported as the number and percentage of participants who achieve OR, a number without dispersion. Response criteria are as follows. Note that any lesion < 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.
| At 12 weeks |
| Systemic (Non-CNS) Disease Control Rate (Cohort A and C) | Systemic (ie, non-central nervous system) disease control (DC) rate by cohort is defined as the number of patients with complete response (CR) + partial response (PR) + stable disease (SD), divided by the total number of patients. The outcome will be reported as DC rate, a number without dispersion. Response criteria are as follows. Note that any lesion < 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.
| At 12 weeks |
| Systemic (Non-CNS) Response Rate (Cohort A and C) | Systemic (ie, non-central nervous system) response rate by cohort is defined as the number of participants achieving a complete response (CR) or partial response (PR), divided by the number of participants. The outcome will be reported as a number without dispersion. Response criteria are as follows. Note that any lesion < 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.
| At 12 weeks |
| Progression-free Survival (PFS) (Cohort A and C) | Progression-free survival (PFS) is defined as the time from the date of start of treatment until disease progression or death. The outcome is reported by cohort as PFS in months, with full range. | Date of first dose of pegylated irinotecan NKTR 102 to date of disease progression, assessed up to 2 years |
| Overall Survival (Cohort A and C) | Overall survival (OS) is defined as the period remaining alive after the start of treatment. The outcome is reported as the median with full range. | 4 years |
| Central Nervous System (CNS) Disease Control (Cohort B) | Central nervous system (CNS) disease control (DC) is defined as a complete response (CR); partial response (PR); or stable disease (SD). The outcome is reported as the number and percentage of participants who achieve DC, a number without dispersion. Response criteria are as follows. Note that any lesion less than 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.
| At 12 weeks |
| Systemic Disease Control (Cohort B) | Systemic (ie, non-central nervous system) disease control (DC) rate by cohort is defined as the number of patients with complete response (CR) + partial response (PR) + stable disease (SD), divided by the total number of patients. The outcome will be reported as DC rate, a number without dispersion. Response criteria are as follows. Note that any lesion < 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.
| At 12 weeks |
| Related Adverse Events (Toxicity) | Toxicity, defined as related adverse events, is reported as the total number of events experienced by the participants in each cohort, a number without dispersion. Related is defined as meaning possibly, probably, or definitely related to the study drug. | Up to 2 years |
| FG001 |
| Cohort B - Pegylated Irinotecan to Treat SCLC |
Patients with small cell lung carinoma (SCLC) will receive pegylated irinotecan NKTR 102 IV over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle) |
| FG002 | Cohort C - Pegylated Irinotecan to Treat mBC | Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan NKTR 102 IV over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle) |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A - Pegylated Irinotecan to Treat NSCLC | Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle) |
| BG001 | Cohort B - Pegylated Irinotecan to Treat SCLC | Patients with small cell lung carinoma (SCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle) |
| BG002 | Cohort C - Pegylated Irinotecan to Treat mBC | Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Central Nervous System (CNS) Disease Control Rate (Cohort A and C) | Central nervous system (CNS) disease control (DC) is defined as a complete response (CR); partial response (PR); or stable disease (SD). The outcome is reported as the number and percentage of participants who achieve DC, a number without dispersion. Response criteria are as follows. Note that any lesion less than 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.
| Cohort B (metastatic small cell lung cancer, SCLC) is excluded per protocol from this outcome. | Posted | Count of Participants | Participants | At 12 weeks |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Disease Control Rate (Cohort A and C) | Overall disease control (DC) rate is defined as the sum in a cohort of the numbers of participants achieving complete response (CR); partial response (PR); or stable disease (SD), divided by the number of patients in that cohort. For this outcome, "overall" means all body systems, not just the central nervous system (CNS). The outcome is reported as DC rate, a number without dispersion. Response criteria are as follows. Note that any lesion <10 mm in longest diameter (LD) is considered unchanged unless there is a ≥3 mm change in the sum of the LDs.
| Cohort B (metastatic small cell lung cancer, SCLC) is excluded per protocol from this outcome. | Posted | Number | participants | At 12 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (Cohort A and C) | Overall response by subject (OR) is defined as the lower assessment between the central nervous system response and the systemic response. Response is defined as either complete response (CR) or partial response (PR). The outcome is reported as the number and percentage of participants who achieve OR, a number without dispersion. Response criteria are as follows. Note that any lesion < 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.
| Cohort B (metastatic small cell lung cancer, SCLC) is excluded per protocol from this outcome. | Posted | Count of Participants | Participants | At 12 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Systemic (Non-CNS) Disease Control Rate (Cohort A and C) | Systemic (ie, non-central nervous system) disease control (DC) rate by cohort is defined as the number of patients with complete response (CR) + partial response (PR) + stable disease (SD), divided by the total number of patients. The outcome will be reported as DC rate, a number without dispersion. Response criteria are as follows. Note that any lesion < 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.
| Cohort B (metastatic small cell lung cancer, SCLC) is excluded per protocol from this outcome. | Posted | Count of Participants | Participants | At 12 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Systemic (Non-CNS) Response Rate (Cohort A and C) | Systemic (ie, non-central nervous system) response rate by cohort is defined as the number of participants achieving a complete response (CR) or partial response (PR), divided by the number of participants. The outcome will be reported as a number without dispersion. Response criteria are as follows. Note that any lesion < 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.
| Cohort B (metastatic small cell lung cancer, SCLC) is excluded per protocol from this outcome. | Posted | Count of Participants | Participants | At 12 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) (Cohort A and C) | Progression-free survival (PFS) is defined as the time from the date of start of treatment until disease progression or death. The outcome is reported by cohort as PFS in months, with full range. | Cohort B (metastatic small cell lung cancer, SCLC) is excluded per protocol from this outcome. | Posted | Median | Full Range | months | Date of first dose of pegylated irinotecan NKTR 102 to date of disease progression, assessed up to 2 years |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (Cohort A and C) | Overall survival (OS) is defined as the period remaining alive after the start of treatment. The outcome is reported as the median with full range. | Cohort B (metastatic small cell lung cancer, SCLC) is excluded per protocol from this outcome. | Posted | Median | Full Range | months | 4 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Central Nervous System (CNS) Disease Control (Cohort B) | Central nervous system (CNS) disease control (DC) is defined as a complete response (CR); partial response (PR); or stable disease (SD). The outcome is reported as the number and percentage of participants who achieve DC, a number without dispersion. Response criteria are as follows. Note that any lesion less than 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.
| This outcome was restricted by protocol to Cohort B. | Posted | Count of Participants | Participants | At 12 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Systemic Disease Control (Cohort B) | Systemic (ie, non-central nervous system) disease control (DC) rate by cohort is defined as the number of patients with complete response (CR) + partial response (PR) + stable disease (SD), divided by the total number of patients. The outcome will be reported as DC rate, a number without dispersion. Response criteria are as follows. Note that any lesion < 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.
| This outcome was restricted by protocol to Cohort B. | Posted | Count of Participants | Participants | At 12 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Related Adverse Events (Toxicity) | Toxicity, defined as related adverse events, is reported as the total number of events experienced by the participants in each cohort, a number without dispersion. Related is defined as meaning possibly, probably, or definitely related to the study drug. | All participants are included. | Posted | Number | adverse events | Up to 2 years |
|
2 years
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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 | Cohort A - Pegylated Irinotecan to Treat NSCLC | Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle) | 11 | 12 | 12 | 12 | 12 | 12 |
| EG001 | Cohort B - Pegylated Irinotecan to Treat SCLC | Patients with small cell lung carinoma (SCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle) | 3 | 3 | 3 | 3 | 3 | 3 |
| EG002 | Cohort C - Pegylated Irinotecan to Treat mBC | Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle) | 11 | 12 | 6 | 12 | 12 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pericardial tamponade | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Disease progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
| |
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
| |
| Edema cerebral | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Intracranial hemorrhage | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | CTCAE v4 | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | CTCAE v4 | Systematic Assessment |
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| Agitation | Psychiatric disorders | CTCAE v4 | Systematic Assessment |
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| Allergic Reaction | Immune system disorders | CTCAE v4 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE v4 | Systematic Assessment |
| |
| Anal Hemorrhage | Gastrointestinal disorders | CTCAE v4 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE v4 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE v4 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | CTCAE v4 | Systematic Assessment |
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| Atrial Fibrillations | Cardiac disorders | CTCAE v4 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE v4 | Systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | CTCAE v4 | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE v4 | Systematic Assessment |
| |
| Body Ache | Musculoskeletal and connective tissue disorders | CTCAE v4 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | CTCAE v4 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | CTCAE v4 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | CTCAE v4 | Systematic Assessment |
| |
| Cardiogenic Shock | Cardiac disorders | CTCAE v4 | Systematic Assessment |
| |
| Chest Wall Pain | Musculoskeletal and connective tissue disorders | CTCAE v4 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE v4 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE v4 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE v4 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v4 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | CTCAE v4 | Systematic Assessment |
| |
| Dermatitis Radiation | Injury, poisoning and procedural complications | CTCAE v4 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE v4 | Systematic Assessment |
| |
| Double vision | Eye disorders | CTCAE v4 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE v4 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE v4 | Systematic Assessment |
| |
| Dysphasia | Nervous system disorders | CTCAE v4 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v4 | Systematic Assessment |
| |
| Edema Face | General disorders | CTCAE v4 | Systematic Assessment |
| |
| Edema Limbs | General disorders | CTCAE v4 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE v4 | Systematic Assessment |
| |
| Eye Pain | Eye disorders | CTCAE v4 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE v4 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE v4 | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE v4 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE v4 | Systematic Assessment |
| |
| Gait disturbance | General disorders | CTCAE v4 | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE v4 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE v4 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE v4 | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE v4 | Systematic Assessment |
| |
| Infusion Related reaction | General disorders | CTCAE v4 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | CTCAE v4 | Systematic Assessment |
| |
| Malaise | General disorders | CTCAE v4 | Systematic Assessment |
| |
| Memory Impairment | Nervous system disorders | CTCAE v4 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE v4 | Systematic Assessment |
| |
| Non Cardiac Pain | General disorders | CTCAE v4 | Systematic Assessment |
| |
| Oral Thrush | Infections and infestations | CTCAE v4 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE v4 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | CTCAE v4 | Systematic Assessment |
| |
| Photophobia | Eye disorders | CTCAE v4 | Systematic Assessment |
| |
| Pupil Constriction | Eye disorders | CTCAE v4 | Systematic Assessment |
| |
| Rectal Pain | Gastrointestinal disorders | CTCAE v4 | Systematic Assessment |
| |
| Right Eye Redness | Eye disorders | CTCAE v4 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE v4 | Systematic Assessment |
| |
| Spinal Fracture | Injury, poisoning and procedural complications | CTCAE v4 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | CTCAE v4 | Systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | CTCAE v4 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE v4 | Systematic Assessment |
| |
| Weight Loss | Investigations | CTCAE v4 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE v4 | Systematic Assessment |
| |
| White Blood Cell Decreased | Investigations | CTCAE v4 | Systematic Assessment |
| |
| Multifocal Atrial Tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Irritability | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mild Transaminitis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vaginal Candidiasis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Upper Respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Altered Mental Status | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Irregular Menstruation | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vaginal pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash Acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash manuco-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Scalp Pain | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Shock Liver | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joel W. Neal, MD PhD, Assistant Professor of Medicine (Oncology) | Stanford University | (650) 498-4696 | jwneal@stanford.edu |
| Jul 26, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| D001932 | Brain Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C581703 | etirinotecan pegol |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Cohort C - Pegylated Irinotecan to Treat mBC |
Cohort C - Pegylated Irinotecan to treat mBC Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle) |
|
|
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle) |
|
|
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
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