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This research study is being conducted to assess the safety of PDT in subjects with peripherally located malignant tumors in lung parenchyma prior to surgical resection. It will involve up to 10 sites in USA. Participation will last 4 months.
Lung cancer accounts for almost one-third of cancer deaths. Cancer screening strategies have the potential to achieve a 20% reduction in death rates. Newly developed bronchoscopic technologies (such as navigational bronchoscopy) have been shown to enable physicians to safely reach lesions in peripheral regions of the lung and obtain diagnosis. This new technology may now potentially offer bronchoscopic therapeutic interventions, such as photodynamic therapy, to tumors that were previously unreachable due to their peripheral anatomic location.
Photodynamic therapy (PDT) uses a combination of a photosensitizing drug (a drug that is activated by light), called porfimer sodium (Photofrin®), and a light from a laser that emits no heat. This technique works to allow the medical doctor to specifically target and destroy abnormal or cancer cells while limiting damage to surrounding healthy tissue. The activation of the drug is done by lightning the abnormal area using a fiber optic device (very fine fiber [like a fishing line] that permits light transmission) inserted into a flexible tube with a light, called bronchoscope for the lung. The light activates the porfimer sodium concentrated in the abnormal tissue, leading to its destruction.
The purpose of this study is to assess the safety of using photodynamic therapy prior to surgical resection of tumors located in the periphery of the lung.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Photodynamic therapy-Photofrin | Experimental | Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Porfimer Sodium | Drug | Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Number of Participants With at Least One Adverse Event | Safety evaluation will include incidence of all adverse events, including serious and non-serious. The count of how many subjects experienced at least one adverse event. | 108 days (to 3 months post surgery) |
| Safety: Physical Examination Summaries of Non-normal Findings for Each Subject | Safety evaluation will include the physical examinations summary of non-normal findings for each subject. | 108 days (to 3 months post surgery) |
| Safety: Vital Sign Summary of Abnormal Findings for Each Subject | Safety evaluation will include vital sign summary for each subject. Only abnormal counts are included. | 108 days (to 3 months post surgery) |
| Safety: Laboratory Tests Summaries of Abnormal Findings for Each Subject | Safety evaluation will include laboratory tests summarized for each subject with any abnormal lab results considered an AE (adverse event) to be listed. | 108 days (to 3 months post surgery) |
| Safety: Skin Photosensitivity Events Summaries of Abnormal Findings for Each Subject | Safety evaluation will include incidence of skin photosensitivity summarized for each subject. | 108 days (to 3 months post surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Macroscopic Tissue Examination | The mean measurement of tumor size after surgery. The largest diameter seen is measured. | Day 13 to 18 |
| Summary of Microscopic Tissue Examination: Percentage of Participants With Complete Response After Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erin O'Neil | Concordia Laboratories Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| University of Colorado |
This is a phase 2 study with only 10 subjects which is of minor use to other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Photodynamic Therapy-Photofrin | Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Photofrin and Photodynamic Therapy | Open label study. All subjects had a 1-time administration of Photofrin and 1-time use of navigational bronchoscopy-PDT. |
| 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 |
| 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 | Safety: Number of Participants With at Least One Adverse Event | Safety evaluation will include incidence of all adverse events, including serious and non-serious. The count of how many subjects experienced at least one adverse event. | Posted | Count of Participants | Participants | 108 days (to 3 months post surgery) |
|
Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
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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 | Photodynamic Therapy-Photofrin | Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment | On Study Day 4, subject received 2 doses of Toradol and on that same day complained of stomachache. On Study Days 4 & 5 subject had diarrhea. On Study Day 5 subject was diagnosed with moderate gastrointestinal bleed (CTCAE Grade 2). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Swelling Face | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment | Face swelling due to photosensitivity reaction. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kim McDonald-Taylor | on behalf of Concordia Laboratories Inc. | 647-267-2942 | kmcdonald-taylor@rogers.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2017 | Aug 13, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2018 | Aug 13, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017323 | Dihematoporphyrin Ether |
| D055100 | Optical Fibers |
| ID | Term |
|---|---|
| D017324 | Hematoporphyrin Derivative |
| D006415 | Hematoporphyrins |
| D011166 | Porphyrins |
| D045725 | Tetrapyrroles |
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| Fiber optic | Device | After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length. |
|
The Percentage of Participants with Complete Response in Tumor area (no non-viable/necrotic tumor) after surgery
| Day 13 to 18 |
| Microscopic Tissue Examination: Percent Tumor Cell Necrosis in Tumor Area After Surgery | The mean with standard deviation of the percent of tumor cell necrosis in the tumor area after surgery. The tumor itself was examined after it was removed to determine the percent of necrosis seen. | Day 13 to 18 |
| Microscopic Tissue Examination: Brisk Inflammatory Reaction After Surgery | The number of participants showing a brisk inflammatory reaction in the tumor area after surgery. This is determined through a histological examination. Brisk Inflammatory Reaction is defined as lymphocytes that infiltrate diffusely the entire tumor and/or infiltrate across the entire base of the tumor. | Day 13 to 18 |
| Microscopic Tissue Examination: Number of Participants With Cavitation in Normal Lung Area After Surgery | The number of participants with cavitation seen in the normal lung area from the microscopic tissue examination after surgery | Day 13 to 18 |
| Microscopic Tissue Examination: Number of Participants With Hemorrhage Seen After Surgery | The Number of Participants with hemorrhage seen during the microscopic tissue examination after surgery | Day 13 to 18 |
| Microscopic Tissue Examination: Number of Participants With Pneumonitis in the Normal Lung After Surgery | The Number of Participants with pneumonitis seen in the normal lung area after surgery following the microscopic tissue examination | Day 13 to 18 |
| Microscopic Tissue Examination: Number of Participants With Increased Alveolar Macrophages in the Normal Lung After Surgery | The number of participants with increased alveolar macrophages post surgery determined in the microscopic tissue examination. | Day 13 to 18 |
| Microscopic Tissue Examination: Number of Participants With Atypical/Reactive Type 2 Pneumocytes in the Normal Lung After Surgery | Number of Participants with Atypical/Reactive Type 2 pneumocytes seen in the normal lung after surgery during the Microscopic Tissue Examination: | Day 13 to 18 |
| Microscopic Tissue Examination: Number of Participants With Mucus Plugging/Mucositis in the Normal Lung After Surgery | Number of Participants with Mucus Plugging/Mucositis seen in the normal lung after surgery during the Microscopic Tissue Examination. | Day 13 to 18 |
| Microscopic Tissue Examination: Number of Participants With Interstitial Fibrosis in the Normal Lung After Surgery | Number of participants with interstitial fibrosis in the normal lung after surgery seen during the Microscopic Tissue Examination | Day 13 to 18 |
| Microscopic Tissue Examination: Number of Participants With Necrosis in the Normal Lung After Surgery | Number of Participants with Necrosis seen in the normal lung after surgery during the Microscopic Tissue Examination | Day 13 to 18 |
| Microscopic Tissue Examination: Number of Participants With Large Vessel Damage Indicated by Fibrinoid Necrosis, Thrombus, Vasculitis in the Normal Lung After Surgery | Number of Participants with Large Vessel Damage indicated by fibrinoid necrosis, thrombus, vasculitis in the normal lung after surgery seen during Microscopic Tissue Examination | Day 13 to 18 |
| Microscopic Tissue Examination: Number of Participants With Acute Alveolar Damage in the Normal Lung After Surgery | Number of Participants with Acute Alveolar damage in the normal lung after surgery seen during the Microscopic Tissue Examination | Day 13 to 18 |
| Microscopic Tissue Examination: Number of Participants With Organizing Pneumonia Pattern in the Normal Lung After Surgery | Number of Participants with Organizing pneumonia pattern in the normal lung after surgery seen during Microscopic Tissue Examination | Day 13 to 18 |
| ECOG (Eastern Cooperative Oncology Group) Performance Status: Baseline | Number of Participants with ECOG Performance at Baseline showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead). | Baseline (-30 to -1 Days) |
| ECOG Performance Status: Period 1 PDT Day 3 | Number of Participants with ECOG Performance Status at Period 1 PDT Day 3, showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead). | Day 3 |
| ECOG Performance Status: Period II Surgery (Day 13-18) | Number of Participants with ECOG Performance Status at Period II Surgery (Day 13-18) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead). | Day 13 to 18 |
| ECOG Performance Status: Period III Follow-up (Day 20-25) | Number of Participants with ECOG Performance Status at Period III Follow-up (Day 20-25) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead). | Day 20 to 25 |
| ECOG Performance Status: Period III Follow-up (Day 43 -48) | Number of Participants with ECOG Performance Status at Period III Follow-up (Day 43 -48) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead). | Day 43 to 48 |
| ECOG Performance Status: Period III Follow-up (Day 103 - 108) | Number of Participants with ECOG Performance Status at Period III Follow-up (Day 103 - 108) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead). | 108 days (to 3 months post surgery) |
| Denver |
| Colorado |
| 80045 |
| United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Cancer Treatment Centers of America/Southeastern | Atlanta | Georgia | 30265 | United States |
| AMITA Health Alexian Brothers Medical Center | Elk Grove Village | Illinois | 60007 | United States |
| Dubois Medical Center | DuBois | Pennsylvania | 15801 | United States |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Providence Health & Services | Spokane | Washington | 99204 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Peripheral Lung Tumor | Count of Participants | Participants |
|
|
|
|
| Secondary | Macroscopic Tissue Examination | The mean measurement of tumor size after surgery. The largest diameter seen is measured. | Photodynamic therapy - Photofrin | Posted | Mean | Standard Deviation | CM | Day 13 to 18 |
|
|
|
| Secondary | Summary of Microscopic Tissue Examination: Percentage of Participants With Complete Response After Surgery | The Percentage of Participants with Complete Response in Tumor area (no non-viable/necrotic tumor) after surgery | Look at complete response in the tumor area | Posted | Number | percentage of participants | Day 13 to 18 |
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|
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| Secondary | Microscopic Tissue Examination: Percent Tumor Cell Necrosis in Tumor Area After Surgery | The mean with standard deviation of the percent of tumor cell necrosis in the tumor area after surgery. The tumor itself was examined after it was removed to determine the percent of necrosis seen. | All subjects were examined for percent tumor cell necrosis in the tumor area | Posted | Mean | Standard Deviation | Percent of tumor | Day 13 to 18 |
|
|
|
| Secondary | Microscopic Tissue Examination: Brisk Inflammatory Reaction After Surgery | The number of participants showing a brisk inflammatory reaction in the tumor area after surgery. This is determined through a histological examination. Brisk Inflammatory Reaction is defined as lymphocytes that infiltrate diffusely the entire tumor and/or infiltrate across the entire base of the tumor. | The brisk inflammatory reaction percentage seen in the tumor area | Posted | Count of Participants | Participants | Day 13 to 18 |
|
|
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| Secondary | Microscopic Tissue Examination: Number of Participants With Cavitation in Normal Lung Area After Surgery | The number of participants with cavitation seen in the normal lung area from the microscopic tissue examination after surgery | Number of participants with cavitation seen in normal lung area | Posted | Count of Participants | Participants | Day 13 to 18 |
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| Secondary | Microscopic Tissue Examination: Number of Participants With Hemorrhage Seen After Surgery | The Number of Participants with hemorrhage seen during the microscopic tissue examination after surgery | Number of Participants with Hemorrhage seen in normal lung area after surgery | Posted | Count of Participants | Participants | Day 13 to 18 |
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| Secondary | Microscopic Tissue Examination: Number of Participants With Pneumonitis in the Normal Lung After Surgery | The Number of Participants with pneumonitis seen in the normal lung area after surgery following the microscopic tissue examination | Microscopic Tissue Examination: Pneumonitis in the normal lung after surgery. Looked at Number of Participants with pneumonitis. | Posted | Count of Participants | Participants | Day 13 to 18 |
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| Secondary | Microscopic Tissue Examination: Number of Participants With Increased Alveolar Macrophages in the Normal Lung After Surgery | The number of participants with increased alveolar macrophages post surgery determined in the microscopic tissue examination. | Posted | Count of Participants | Participants | Day 13 to 18 |
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| Secondary | Microscopic Tissue Examination: Number of Participants With Atypical/Reactive Type 2 Pneumocytes in the Normal Lung After Surgery | Number of Participants with Atypical/Reactive Type 2 pneumocytes seen in the normal lung after surgery during the Microscopic Tissue Examination: | Number of Participants with Atypical/Reactive Type 2 Pneumocytes in the normal lung after surgery determined during the Microscopic Tissue Examination. | Posted | Count of Participants | Participants | Day 13 to 18 |
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| Secondary | Microscopic Tissue Examination: Number of Participants With Mucus Plugging/Mucositis in the Normal Lung After Surgery | Number of Participants with Mucus Plugging/Mucositis seen in the normal lung after surgery during the Microscopic Tissue Examination. | Posted | Count of Participants | Participants | Day 13 to 18 |
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| Secondary | Microscopic Tissue Examination: Number of Participants With Interstitial Fibrosis in the Normal Lung After Surgery | Number of participants with interstitial fibrosis in the normal lung after surgery seen during the Microscopic Tissue Examination | Posted | Count of Participants | Participants | Day 13 to 18 |
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| Secondary | Microscopic Tissue Examination: Number of Participants With Necrosis in the Normal Lung After Surgery | Number of Participants with Necrosis seen in the normal lung after surgery during the Microscopic Tissue Examination | Number of Participants with Necrosis in the normal lung after surgery | Posted | Count of Participants | Participants | Day 13 to 18 |
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| Secondary | Microscopic Tissue Examination: Number of Participants With Large Vessel Damage Indicated by Fibrinoid Necrosis, Thrombus, Vasculitis in the Normal Lung After Surgery | Number of Participants with Large Vessel Damage indicated by fibrinoid necrosis, thrombus, vasculitis in the normal lung after surgery seen during Microscopic Tissue Examination | Posted | Count of Participants | Participants | Day 13 to 18 |
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| Secondary | Microscopic Tissue Examination: Number of Participants With Acute Alveolar Damage in the Normal Lung After Surgery | Number of Participants with Acute Alveolar damage in the normal lung after surgery seen during the Microscopic Tissue Examination | Posted | Count of Participants | Participants | Day 13 to 18 |
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| Secondary | Microscopic Tissue Examination: Number of Participants With Organizing Pneumonia Pattern in the Normal Lung After Surgery | Number of Participants with Organizing pneumonia pattern in the normal lung after surgery seen during Microscopic Tissue Examination | Posted | Count of Participants | Participants | Day 13 to 18 |
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| Secondary | ECOG (Eastern Cooperative Oncology Group) Performance Status: Baseline | Number of Participants with ECOG Performance at Baseline showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead). | Posted | Count of Participants | Participants | Baseline (-30 to -1 Days) |
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| Secondary | ECOG Performance Status: Period 1 PDT Day 3 | Number of Participants with ECOG Performance Status at Period 1 PDT Day 3, showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead). | Posted | Count of Participants | Participants | Day 3 |
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| Secondary | ECOG Performance Status: Period II Surgery (Day 13-18) | Number of Participants with ECOG Performance Status at Period II Surgery (Day 13-18) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead). | Posted | Count of Participants | Participants | Day 13 to 18 |
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| Secondary | ECOG Performance Status: Period III Follow-up (Day 20-25) | Number of Participants with ECOG Performance Status at Period III Follow-up (Day 20-25) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead). | Posted | Count of Participants | Participants | Day 20 to 25 |
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| Secondary | ECOG Performance Status: Period III Follow-up (Day 43 -48) | Number of Participants with ECOG Performance Status at Period III Follow-up (Day 43 -48) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead). | Posted | Count of Participants | Participants | Day 43 to 48 |
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| Secondary | ECOG Performance Status: Period III Follow-up (Day 103 - 108) | Number of Participants with ECOG Performance Status at Period III Follow-up (Day 103 - 108) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead). | Posted | Count of Participants | Participants | 108 days (to 3 months post surgery) |
|
|
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| Primary | Safety: Physical Examination Summaries of Non-normal Findings for Each Subject | Safety evaluation will include the physical examinations summary of non-normal findings for each subject. | Posted | Count of Participants | Participants | 108 days (to 3 months post surgery) |
|
|
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| Primary | Safety: Vital Sign Summary of Abnormal Findings for Each Subject | Safety evaluation will include vital sign summary for each subject. Only abnormal counts are included. | Posted | Count of Participants | Participants | 108 days (to 3 months post surgery) |
|
|
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| Primary | Safety: Laboratory Tests Summaries of Abnormal Findings for Each Subject | Safety evaluation will include laboratory tests summarized for each subject with any abnormal lab results considered an AE (adverse event) to be listed. | Posted | Count of Participants | Participants | 108 days (to 3 months post surgery) |
|
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| Primary | Safety: Skin Photosensitivity Events Summaries of Abnormal Findings for Each Subject | Safety evaluation will include incidence of skin photosensitivity summarized for each subject. | Posted | Count of Participants | Participants | 108 days (to 3 months post surgery) |
|
|
|
|
| 0 |
| 10 |
| 4 |
| 10 |
| 10 |
| 10 |
|
| Hemorrhagic Shock | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment | Subject hospitalized for scheduled right colectomy for colon cancer and experienced hemorrhagic shock (CTCAE Grade 4). |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment | Subject hospitalized for scheduled right colectomy for colon cancer and experienced pleural effusion (recurrent right pleural effusion CTCAE Grade 2). |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment | Subject hospitalized for scheduled right colectomy for colon cancer and experienced acute hypoxemic respiratory failure CTCAE Grade 4. |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment | Subject hospitalized for scheduled right colectomy for colon cancer and experienced anemia CTCAE Grade 3. |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment | Subject hospitalized for scheduled right colectomy for colon cancer and experienced iatrogenic right haemothorax CTCAE Grade 3 diagnosed from CT angiogram. |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA (17.1) | Systematic Assessment | Subject hospitalized for scheduled right colectomy for colon cancer and experienced atrial fibrillation with rapid ventricular response CTCAE Grade 2 that converted to sinus. |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment | Subject hospitalized for scheduled right colectomy for colon cancer and experienced dyspnoea CTCAE Grade 2. |
|
| Sepsis | Infections and infestations | MedDRA (17.1) | Systematic Assessment | Subject hospitalized with symptoms of cough, fever and chills resulting from sepsis CTCAE Grade 1. |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment | Hospitalized with pneumonia aspiration CTCAE Grade 2 along with sepsis. |
|
| Gastro-oesophageal reflux disease | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment | While hospitalized for sepsis and pneumonia aspiration, subject experience CTCAE Grade 2 SAE (Serious Adverse Event) of gastrooesophageal reflux disease |
|
| Deep Vein Thrombosis (DVT) Right | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment | Hospitalized with CTCAE Grade 3 deep vein thrombosis right. |
|
| Deep Vein Thrombosis Left | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment | While hospitalized with DVT Right, subject experienced a CTCAE Grade 2 SAE of deep vein thrombosis left. |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
|
|
| Facial Blisters | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment | Blisters on face due to photosensitivity to drug. |
|
| Forearm Erythema | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment | Skin erythema on both forearms |
|
| Hand Erythema | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment | Mild hand erythema from photosensitivity to study drug. |
|
| Facial erythema | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment | Dermal erythema (sunburn) on face due to photosensitivity to study drug |
|
| Erythema on calves | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment | Dermal erythema (sunburn) on calves due to photosensitivity to study drug |
|
| Abdomen erythema | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment | Abdomen redness due to photosensitivity to study drug. |
|
| Bradycardia | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
|
| Congenital diaphragmatic hernia | Congenital, familial and genetic disorders | MedDRA (17.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Tenderness | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Blood alkaline phosphatase decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Blood creatinine decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Blood urea abnormal | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Chest x-ray abnormal | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| False negative investigation result | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Hematocrit decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Hematocrit increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Hemoglobin decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Hemoglobin increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Prothrombin time abnormal | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Prothrombin time prolonged | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Red blood cell count increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Respiratory rate increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| x-ray abnormal | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| Protein deficiency | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
|
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Respiratory abnormal | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Thoracic operation | Surgical and medical procedures | MedDRA (17.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| Blood Sodium increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Prothrombin time shortened | Investigations | MedDRA (17.1) | Systematic Assessment |
|
Not provided
Not provided
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011758 |
| Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| None |
|
| Title | Measurements |
|---|---|
|