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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00085870 | Other Identifier | JHMIRB |
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| Name | Class |
|---|---|
| Van Andel Research Institute | OTHER |
| Astex Pharmaceuticals, Inc. | INDUSTRY |
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This is a phase I/II study of the combination of Guadecitabine (SGI-110) and previously treated metastatic colorectal cancer patients. This study will be conducted in two components. First, patients will be enrolled in a phase I study of SGI-110 combined with irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined, patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and irinotecan versus the standard of care regorafenib or Lonsurf (TAS-102).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Dose Escalation | Experimental | Subjects receive SGI-110 on days 1-5 and irinotecan on days 8 and 15 of each 28-day cycle. Various doses of SGI-110 are tested to determine the maximum tolerated dose in combination with irinotecan. |
|
| Phase 2: Arm A SGI-110 + irinotecan | Experimental | Subjects receive SGI-110 on days 1-5 and irinotecan on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) is given during cycle 1 with option to give additional growth factor support at subsequent cycles per clinician judgement. |
|
| Phase 2: Arm B regorafenib or TAS-102 | Active Comparator | Subjects received either regorafenib or TAS-102 based on physician and patient preference. Subjects that had received one of these standard of care drugs (regorafenib or TAS-102) prior to enrollment received the other on study. Regorafenib taken daily from days 1-21 of each 28-day cycle or TAS-102 taken twice daily on days 1-5 and 8-12 of each 28-day cycle. Subjects who had disease progression on Arm B were given the option to receive Arm A study drugs after a 14 day wash-out period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGI-110 Dose Escalation | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing a Dose Limiting Toxicity | Number of participants experiencing a Dose Limiting Toxicity (DLT) in each dose level. DLT is defined as any of the following study drug-related toxicities occurring during the first cycle of study drug on study:
| 28 days |
| Progression Free Survival (PFS) | Progression Free Survival is the time (in months) from start of treatment to progression, clinical deterioration attributed to disease, or death. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall Survival is defined as the time (in months) between the start of treatment and death. | Up to 3 years |
| Objective Response Rate | Objective Response Rate (ORR) is defined as the number of subjects achieving a Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. CR = disappearance of all target lesions, PR = at least 30% decrease in the sum of diameters of target lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nilo Azad, MD | SKCCC at JHMI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States | ||
| Sidney Kimmel Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38312102 | Derived | Lee V, Parkinson R, Zahurak M, Cope L, Cercek A, Verheul H, Gootjes E, Lenz HJ, Iqbal S, Jones P, Baylin S, Rami V, Ahuja N, El Khoueiry A, Azad NS. A phase II study of guadecitabine combined with irinotecan vs regorafenib or TAS-102 in irinotecan-refractory metastatic colorectal cancer patients. Int J Cancer. 2024 May 15;154(10):1794-1801. doi: 10.1002/ijc.34845. Epub 2024 Feb 5. | |
| 28445481 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: Dose Level 1 | Guadecitabine (SGI-110) 45 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle. |
| FG001 | Phase 1: Dose Level -1 |
| 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 5, 2020 |
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In Phase 2, Arm B patients who have disease progression will be given the option to receive Arm A study drugs.
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|
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| Regorafenib | Drug | 160 mg taken orally |
|
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| TAS-102 | Drug | 35 mg/m^2 taken orally |
|
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| SGI-110 | Drug | 45 mg/m^2 administered as a subcutaneous injection |
|
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| Irinotecan | Drug | 125 mg/m^2 administered IV |
|
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| Assessed until disease progression, up to 3 years |
| Baltimore |
| Maryland |
| 21231 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| VU Medisch Centrum | Amsterdam | 1081 HV | Netherlands |
| Derived |
| Sharma A, Vatapalli R, Abdelfatah E, Wyatt McMahon K, Kerner Z, A Guzzetta A, Singh J, Zahnow C, B Baylin S, Yerram S, Hu Y, Azad N, Ahuja N. Hypomethylating agents synergize with irinotecan to improve response to chemotherapy in colorectal cancer cells. PLoS One. 2017 Apr 26;12(4):e0176139. doi: 10.1371/journal.pone.0176139. eCollection 2017. |
Guadecitabine (SGI-110) 30 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle. |
| FG002 | Phase 1: Dose Level -1G | Guadecitabine (SGI-110) 30 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) mandatory during cycle 1, and given per clinician judgement cycle 2 and beyond. |
| FG003 | Phase 1: Dose Level 1G | Guadecitabine (SGI-110) 45 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) mandatory during cycle 1, and given per clinician judgement cycle 2 and beyond. |
| FG004 | Phase 2: Arm A SGI-110 + Irinotecan | SGI-110 45 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) was given during cycle 1 with option to give additional growth factor support at subsequent cycles per clinician judgement. |
| FG005 | Phase 2: Arm B Regorafenib or TAS-102 | Subjects received either regorafenib or Lonsurf (TAS-102). Regorafenib 160 mg was taken orally daily from days 1-21 of each 28-day cycle or TAS-102 35 mg/m^2 was taken orally twice daily on days 1-5 and 8-12 of each 28-day cycle. Subjects that had previously received one of these standard of care drugs (regorafenib or TAS-102) received the other on study. For subjects that had never received either regorafenib or TAS-102, the choice of therapy was deferred to the treating physician and patient. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: Dose Level 1 | Guadecitabine (SGI-110) 45 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle. |
| BG001 | Phase 1: Dose Level -1 | Guadecitabine (SGI-110) 30 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle. |
| BG002 | Phase 1: Dose Level -1G | Guadecitabine (SGI-110) 30 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) mandatory during cycle 1, and given per clinician judgement cycle 2 and beyond. |
| BG003 | Phase 1: Dose Level 1G | Guadecitabine (SGI-110) 45 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) mandatory during cycle 1, and given per clinician judgement cycle 2 and beyond. |
| BG004 | Phase 2: Arm A SGI-110 + Irinotecan | SGI-110 45 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) was given during cycle 1 with option to give additional growth factor support at subsequent cycles per clinician judgement. |
| BG005 | Phase 2: Arm B Regorafenib or TAS-102 | Subjects received either regorafenib or TAS-102. Regorafenib 160 mg was taken orally daily from days 1-21 of each 28-day cycle or TAS-102 35 mg/m^2 was taken orally twice daily on days 1-5 and 8-12 of each 28-day cycle. Subjects that had previously received one of these standard of care drugs (regorafenib or TAS-102) received the other on study. For subjects that had never received either regorafenib or TAS-102, the choice of therapy was deferred to the treating physician and patient. |
| BG006 | 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, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Number of Participants Experiencing a Dose Limiting Toxicity | Number of participants experiencing a Dose Limiting Toxicity (DLT) in each dose level. DLT is defined as any of the following study drug-related toxicities occurring during the first cycle of study drug on study:
| Per protocol, Dose Limiting Toxicities were only assessed in Phase 1 subjects in order to determine the Phase 2 dose of SGI-110. 1 Patient in Dose Level -1G was taken off study for non-compliance due to transportation issues before completion of Cycle 1 and was not considered evaluable for DLT analysis. | Posted | Count of Participants | Participants | 28 days |
|
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| |||||||||||||||||||||||||||||||||||
| Primary | Progression Free Survival (PFS) | Progression Free Survival is the time (in months) from start of treatment to progression, clinical deterioration attributed to disease, or death. | Per protocol, the progression-free survival objective was only assessed in Phase 2 subjects. 18 subjects who received Arm B treatment were eligible to "crossover" to receive Arm A treatment. These participants were not included in the number analyzed in Arm A because they were not assessed for progression free survival after Arm A treatment. | Posted | Median | 95% Confidence Interval | months | Up to 12 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall Survival is defined as the time (in months) between the start of treatment and death. | Per protocol, the overall survival objective was only assessed in Phase 2 subjects. 18 subjects who received Arm B treatment and were eligible to "crossover" to receive Arm A treatment were not included in the number analyzed in Arm A because they were not assessed for overall survival after receiving Arm A treatment. | Posted | Median | 95% Confidence Interval | months | Up to 3 years |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate | Objective Response Rate (ORR) is defined as the number of subjects achieving a Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. CR = disappearance of all target lesions, PR = at least 30% decrease in the sum of diameters of target lesions. | ORR only assessed for Phase 2. 5 from Arm A and 2 from Arm B were excluded from response rate analysis as they didn't get a follow-up scan. 18 subjects in Arm B were eligible to "crossover" to receive Arm A treatment. They were not included in the number analyzed in Arm A because they were not assessed for objective response after Arm A treatment. | Posted | Count of Participants | Participants | Assessed until disease progression, up to 3 years |
|
Adverse Events (AEs) were collected from the first dose of study drug through 30 days after the last dose of study drug, up to 13 months
18 patients from Arm B were eligible to "crossover" to receive Arm A study treatment after they had progression with Arm B treatment. They were assessed for adverse events after receiving Arm A treatment. Their adverse events are reported here in a separate arm.
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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 | Phase 1: Dose Level 1 | Guadecitabine (SGI-110) 45 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle. | 0 | 6 | 1 | 6 | 6 | 6 |
| EG001 | Phase 1: Dose Level -1 | Guadecitabine (SGI-110) 30 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle. | 0 | 3 | 1 | 3 | 3 | 3 |
| EG002 | Phase 1: Dose Level -1G | Guadecitabine (SGI-110) 30 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) mandatory during cycle 1, and given per clinician judgement cycle 2 and beyond. | 0 | 7 | 2 | 7 | 6 | 7 |
| EG003 | Phase 1: Dose Level 1G | Guadecitabine (SGI-110) 45 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) mandatory during cycle 1, and given per clinician judgement cycle 2 and beyond. | 1 | 6 | 1 | 6 | 6 | 6 |
| EG004 | Phase 2: Arm A SGI-110 + Irinotecan | SGI-110 45 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) was given during cycle 1 with option to give additional growth factor support at subsequent cycles per clinician judgement. | 3 | 62 | 15 | 62 | 58 | 62 |
| EG005 | Phase 2: "Crossover" to Arm A From Arm B | Per protocol, Arm B subjects were given the option to "crossover" and receive Arm A study drugs after disease progression on Arm B. 18 Arm B subjects received Arm A study drugs after initial progression. SGI-110 45 mg/m^2 was administered as a subcutaneous injection on days 1-5 of each 28-day cycle. Irinotecan 125 mg/m^2 was administered IV on days 8 and 15 of each 28-day cycle. Growth factor support (filgrastim and peg-filgrastim) was given during cycle 1 with option to give additional growth factor support at subsequent cycles per clinician judgement. | 0 | 18 | 8 | 18 | 18 | 18 |
| EG006 | Phase 2: Arm B Regorafenib or TAS-102 | Subjects received either regorafenib or TAS-102. Regorafenib 160 mg was taken orally daily from days 1-21 of each 28-day cycle or TAS-102 35 mg/m^2 was taken orally twice daily on days 1-5 and 8-12 of each 28-day cycle. Subjects that had previously received one of these standard of care drugs (regorafenib or TAS-102) received the other on study. For subjects that had never received either regorafenib or TAS-102, the choice of therapy was deferred to the treating physician and patient. | 4 | 34 | 1 | 34 | 30 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Fatigue or Malaise | General disorders | Non-systematic Assessment |
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| Fever | General disorders | Non-systematic Assessment |
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| Bacteremia | Infections and infestations | Non-systematic Assessment |
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| Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Skin infection | Infections and infestations | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Wound infection | Infections and infestations | Non-systematic Assessment |
| ||
| Blood bilirubin increased | Investigations | Non-systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | Non-systematic Assessment |
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| Glucose intolerance | Endocrine disorders | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Mucositis oral | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Chills | General disorders | Non-systematic Assessment |
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| Edema limbs | General disorders | Non-systematic Assessment |
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| Fatigue or malaise | General disorders | Non-systematic Assessment |
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| Fever | General disorders | Non-systematic Assessment |
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| Injection site reaction | General disorders | Non-systematic Assessment |
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| Abscess or skin infection | Infections and infestations | Non-systematic Assessment |
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| Bruising | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Alkaline phosphatase increased | Investigations | Non-systematic Assessment |
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| ALT increased | Investigations | Non-systematic Assessment |
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| AST increased | Investigations | Non-systematic Assessment |
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| Blood bilirubin increased | Investigations | Non-systematic Assessment |
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| Weight loss | Investigations | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hyperglycemia | Investigations | Non-systematic Assessment |
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| Hypocalcemia | Investigations | Non-systematic Assessment |
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| Hypophosphatemia | Investigations | Non-systematic Assessment |
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| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Palmar-plantar erythrodysesthesia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Hypotension | Vascular disorders | Non-systematic Assessment |
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The Principal Investigators (PIs) from participating sites must provide the Johns Hopkins PI with a copy of any proposed publication for review and comment at least 30 days prior to submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nilofer Azad | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 410-614-9169 | nazad2@jhmi.edu |
| Aug 14, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C580831 | guadecitabine |
| C559147 | regorafenib |
| C000613803 | trifluridine tipiracil drug combination |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
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| 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 |
|
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