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Study terminated prematurely due to internal corporate decision
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A Phase 1 dose escalation study to evaluate APR003 in patients with advanced colorectal cancer (CRC) with malignant liver lesions
APR003 is a small molecule TLR7 agonist that concentrates in the GI, and liver with limited systemic exposure. It is designed to increase the therapeutic window of a TLR7 agonist by minimizing the side-effects associated with generalized systemic immune activation and inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APR003 Dose Escalation | Experimental | This portion of the study will evaluate the safety and pharmacokinetics of a range of APR003 doses administered once a week for 21 days in subjects with advance colorectal cancer (CRC) with metastases to the liver and to determine the RP2D. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APR003 | Drug | This portion of the study further explores the clinical activity, safety, pharmacokinetics and pharmacology of APR003 monotherapy at the RP2D and to assess the antitumor activity of APR003 in subjects with unresectable CRC with liver metastases. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the Number of Patients With Dose Limiting Toxicities (DLTs) | Determine the number of patients who have experienced a Dose Limiting Toxicities (DLT) evaluated by the investigator based on CTCAE Severity Grade. | Until disease progression, or up to approximately 15 months and 18 days, whichever is first |
| Maximum Concentration (Cmax) of APR003 | Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods. | Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days) |
| Time-to-maximum Concentration (Tmax) of APR003 | Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods. | Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days) |
| Area Under the Curve (AUC) From Time Zero to 24 hr (AUC0-24) of APR003 | Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods. | Cycle 1 Day 1, Cycle 1 Day 15 (Cycle duration is 21 days) |
| AUC From Time Zero to Time Infinity (AUC0-ꝏ) of APR003 | Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods. | Cycle 1 Day 1 (Cycle duration is 21 days) |
| AUC Over the Dosing Interval (AUClast) of APR003 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective response rate (ORR), defined as the proportion of patients with either a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 | Until disease progression, or up to approximately 15 months and 18 days, whichever is first |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Weitzman, MD | Apros Therapeutics, Inc | Study Director |
| Trinh Le | Apros Therapeutics, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth Orlando | Orlando | Florida | 32803 | United States | ||
| Carolina BioOncology Institute Cancer Research Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Miller A, Le T, Holland J, et al1167 APR003, an oral liver- and GI-targeted TLR7 agonist, elicits a robust type I interferon response in advanced colorectal cancer patientsJournal for ImmunoTherapy of Cancer 2022;10:doi: 10.1136/jitc-2022-SITC2022.1167 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort -1 | 25 MG once a week for 21 days in subjects with advance colorectal cancer (CRC) with metastases to the liver and to determine the RP2D. |
| FG001 | Cohort 1 | 50 MG once a week for 21 days in subjects with advance colorectal cancer (CRC) with metastases to the liver and to determine the RP2D. |
| FG002 | Cohort 2 | 100 MG once a week for 21 days in subjects with advance colorectal cancer (CRC) with metastases to the liver and to determine the RP2D. |
| FG003 | Cohort 3 | 175 MG once a week for 21 days in subjects with advance colorectal cancer (CRC) with metastases to the liver and to determine the RP2D. |
| FG004 | Cohort 4 | 250 MG once a week for 21 days in subjects with advance colorectal cancer (CRC) with metastases to the liver and to determine the RP2D. |
| FG005 | Cohort 5 | 350 MG once a week for 21 days in subjects with advance colorectal cancer (CRC) with metastases to the liver and to determine the RP2D. |
| FG006 | Cohort 6 | 500 MG once a week for 21 days in subjects with advance colorectal cancer (CRC) with metastases to the liver and to determine the RP2D. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort -1 | 25 MG once a week |
| BG001 | Cohort 1 | 50 MG once a week |
| BG002 |
| 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 | Determine the Number of Patients With Dose Limiting Toxicities (DLTs) | Determine the number of patients who have experienced a Dose Limiting Toxicities (DLT) evaluated by the investigator based on CTCAE Severity Grade. | Posted | Number | participants | Until disease progression, or up to approximately 15 months and 18 days, whichever is first |
|
Until disease progression, or up to approximately 15 months and 18 days, whichever is first
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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 -1 | 25 MG once weekly | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cytokine release syndrome | Immune system disorders | CTCAE v5.0 | Systematic Assessment | Dose Limiting Toxicity (DLT) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders | CTCAE v5.0 | Systematic Assessment |
The primary limitation of this study was its small sample size. While it is difficult to draw firm conclusions on such a small cohort of patients, several preliminary conclusions can be drawn.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tom Wu, PhD | Apros Therapeutics | +1-858-284-8839 | tom_wu@aprostx.com |
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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 | Jan 28, 2022 | Jun 24, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 28, 2022 | Dec 29, 2023 | ICF_001.pdf |
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Phase 1 Dose Escalation
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Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods. |
| Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days) |
| Elimination Half-life (T1/2) of APR003 | Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods. | Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days) |
| Apparent Volume of Distribution at Steady State After Administration (Vss/F) of APR003 | Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods. | Cycle 1 Day 1 (Cycle duration is 21 days) |
| Apparent Total Plasma Clearance (CL/F) of APR003 | Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods. | Cycle 1 Day 1 (Cycle duration is 21 days) |
| Huntersville |
| North Carolina |
| 28078 |
| United States |
| NEXT Oncology - Austin | Austin | Texas | 78758 | United States |
| NEXT Oncology - San Antonio | San Antonio | Texas | 78229 | United States |
| Death |
|
| Cohort 2 |
100 MG once a week |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| 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 |
|
| Region of Enrollment | All patients enrolled in United States | Number | participants |
|
| ECOG Performance Status | Eastern Cooperative Oncology Group (ECOG) performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active), 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature) to 5 (dead). | Median | Full Range | units on a scale |
|
| Stage at Trial Entry | Tumor stage at trial entry was classified according to the American Joint Committee on Cancer (AJCC) 8th Edition staging system. All participants had Stage IV disease, with substages distributed as follows: IVB, IV, and IVC. Higher stage substages indicate more advanced disease. | Count of Participants | Participants |
|
| Current Stage-Tumor (T) | Current Tumor (T) stage at trial entry was assessed according to the AJCC 8th Edition staging system. The substages ranged from T2 through T4a, with higher T categories indicating larger tumor size and/or greater local invasion. | Count of Participants | Participants |
|
| Current Stage-Metastasis (M) | Current Metastasis (M) stage at trial entry was assessed according to the AJCC 8th Edition staging system. Only patients with M1 and M1b disease were enrolled, representing the presence of distant metastases. Higher M categories indicate more extensive metastatic spread. | Count of Participants | Participants |
|
| Primary Tumor Location | Count of Participants | Participants |
|
| Colorectal Type | Count of Participants | Participants |
|
| Grade at Study Entry | Tumor grade at study entry was assessed using standard histopathologic criteria. Enrolled patients included those with Grade 1 (G1), Grade 2 (G2), Grade X (GX; undetermined grade), and unknown grade. Lower grades (G1) generally indicate well-differentiated tumors with better prognosis, while higher grades indicate poorer differentiation and more aggressive disease. | Count of Participants | Participants |
|
100 MG once a week
|
|
| Primary | Maximum Concentration (Cmax) of APR003 | Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods. | One patient in Cohort 1 was dose-reduced after the first dose from 50 MG to 25 MG and was included only in the Cycle 1 Day 1 analysis. The only patient in Cohort 2 was not analyzed due to incomplete blood collection. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days) |
|
|
|
| Primary | Time-to-maximum Concentration (Tmax) of APR003 | Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods. | One patient in Cohort 1 was dose-reduced after the first dose from 50 MG to 25 MG and was included only in the Cycle 1 Day 1 analysis. The only patient in Cohort 2 was not analyzed due to incomplete blood collection. | Posted | Mean | Full Range | hr | Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days) |
|
|
|
| Primary | Area Under the Curve (AUC) From Time Zero to 24 hr (AUC0-24) of APR003 | Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods. | One patient in Cohort 1 was dose-reduced after the first dose from 50 MG to 25 MG and was included only in the Cycle 1 Day 1 analysis. The only patient in Cohort 2 was not analyzed due to incomplete blood collection. | Posted | Mean | Standard Deviation | ng*hr/mL | Cycle 1 Day 1, Cycle 1 Day 15 (Cycle duration is 21 days) |
|
|
|
| Primary | AUC From Time Zero to Time Infinity (AUC0-ꝏ) of APR003 | Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods. | One patient in Cohort 1 was dose-reduced after the first dose from 50 MG to 25 MG and was included only in the Cycle 1 Day 1 analysis. The only patient in Cohort 2 was not analyzed due to incomplete blood collection. | Posted | Mean | Standard Deviation | ng*hr/mL | Cycle 1 Day 1 (Cycle duration is 21 days) |
|
|
|
| Primary | AUC Over the Dosing Interval (AUClast) of APR003 | Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods. | One patient in Cohort 1 was dose-reduced after the first dose from 50 MG to 25 MG and was included only in the Cycle 1 Day 1 analysis. The only patient in Cohort 2 was not analyzed due to incomplete blood collection. | Posted | Mean | Standard Deviation | ng*hr/mL | Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days) |
|
|
|
| Primary | Elimination Half-life (T1/2) of APR003 | Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods. | One patient in Cohort 1 was dose-reduced after the first dose from 50 MG to 25 MG and was included only in the Cycle 1 Day 1 analysis. The only patient in Cohort 2 was not analyzed due to incomplete blood collection. | Posted | Mean | Standard Deviation | hr | Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days) |
|
|
|
| Primary | Apparent Volume of Distribution at Steady State After Administration (Vss/F) of APR003 | Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods. | One patient in Cohort 1 was dose-reduced after the first dose from 50 MG to 25 MG and was included only in the Cycle 1 Day 1 analysis. The only patient in Cohort 2 was not analyzed due to incomplete blood collection. | Posted | Mean | Standard Deviation | L | Cycle 1 Day 1 (Cycle duration is 21 days) |
|
|
|
| Primary | Apparent Total Plasma Clearance (CL/F) of APR003 | Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods. | One patient in Cohort 1 was dose-reduced after the first dose from 50 MG to 25 MG and was included only in the Cycle 1 Day 1 analysis. The only patient in Cohort 2 was not analyzed due to incomplete blood collection. | Posted | Mean | Standard Deviation | L/hr | Cycle 1 Day 1 (Cycle duration is 21 days) |
|
|
|
| Secondary | Objective Response Rate | Objective response rate (ORR), defined as the proportion of patients with either a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 | Posted | Count of Participants | Participants | Until disease progression, or up to approximately 15 months and 18 days, whichever is first |
|
|
|
| 6 |
| 2 |
| 6 |
| 6 |
| 6 |
| EG001 | Cohort 1 | 50 MG once weekly | 1 | 4 | 0 | 4 | 3 | 4 |
| EG002 | Cohort 2 | 100 MG once weekly | 0 | 1 | 1 | 1 | 1 | 1 |
|
| Progression of Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v5.0 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v5.0 | Systematic Assessment |
|
| Post-surgical Pain | Injury, poisoning and procedural complications | CTCAE v5.0 | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE v5.0 | Systematic Assessment |
|
| Intermittent fever | General disorders | CTCAE v5.0 | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE v5.0 | Systematic Assessment |
|
| Left chest wall discomfort | General disorders | CTCAE v5.0 | Systematic Assessment |
|
| Intermittent low grade fever | General disorders | CTCAE v5.0 | Systematic Assessment |
|
| Intermittent fatigue | General disorders | CTCAE v5.0 | Systematic Assessment |
|
| Increase thirst | General disorders | CTCAE v5.0 | Systematic Assessment |
|
| Intermittent fever | General disorders | CTCAE v5.0 | Systematic Assessment |
|
| Intermittent generalized body aches | General disorders | CTCAE v5.0 | Systematic Assessment |
|
| Rigors | General disorders | CTCAE v5.0 | Systematic Assessment |
|
| Intermittent chills | General disorders | CTCAE v5.0 | Systematic Assessment |
|
| Edema bilateral lower extremities | General disorders | CTCAE v5.0 | Systematic Assessment |
|
| Intermittent body aches | General disorders | CTCAE v5.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Vomiting Intermittent | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Nausea Intermittent | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Abdominal pain (gas) | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Dark colored diarrhea | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Emesis | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Worsening diarrhea | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Stomach cramps | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Xerostomia | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Mouth sores | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Left upper quadrant abdominal discomfort following meals | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Intermittent abdominal pain | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Epigastric apin | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Systematic Assessment |
|
| Intermitten flank pain | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Systematic Assessment |
|
| Muscle spasm | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Systematic Assessment |
|
| Left flank pain | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Systematic Assessment |
|
| Intermittent right flank pain | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Systematic Assessment |
|
| Intermittent myalgias | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Systematic Assessment |
|
| Bilateral flank pain | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE v5.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE v5.0 | Systematic Assessment |
|
| Worsening lymphopenia | Blood and lymphatic system disorders | CTCAE v5.0 | Systematic Assessment |
|
| Iron deficiency anemia | Blood and lymphatic system disorders | CTCAE v5.0 | Systematic Assessment |
|
| Intermittent anemia | Blood and lymphatic system disorders | CTCAE v5.0 | Systematic Assessment |
|
| Lymphocytopenia | Blood and lymphatic system disorders | CTCAE v5.0 | Systematic Assessment |
|
| Anemia of chronic disease | Blood and lymphatic system disorders | CTCAE v5.0 | Systematic Assessment |
|
| Positive COVID-10 test (symptomatic) | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
|
| Bacterial sinusitis | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
|
| Bladder infection | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
|
| Left lower extremity cellulitis | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
|
| Oral thrush | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
|
| Left upper extremity ringworm | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
|
| Chronic UTI | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
|
| Fever blisters on lower lip | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
|
| Elevation of creatinine | Investigations | CTCAE v5.0 | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE v5.0 | Systematic Assessment |
|
| Intermittent elevation of alkaline phosphatase | Investigations | CTCAE v5.0 | Systematic Assessment |
|
| Elevated alanine transaminase | Investigations | CTCAE v5.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | CTCAE v5.0 | Systematic Assessment |
|
| AST increased | Investigations | CTCAE v5.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Pleural effusion right lung | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Residual dry cough | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | CTCAE v5.0 | Systematic Assessment |
|
| Seasonal allergies | Immune system disorders | CTCAE v5.0 | Systematic Assessment |
|
| Disease progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v5.0 | Systematic Assessment |
|
| Worsening of colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v5.0 | Systematic Assessment |
|
| Intermittent tumor pain in RUQ/LUQ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v5.0 | Systematic Assessment |
|
| Intermittent lower abdominal tumor pain flare | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v5.0 | Systematic Assessment |
|
| Lower abdominal tumor flare pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v5.0 | Systematic Assessment |
|
| Right-sided pleuritic chest tumor flare reaction | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v5.0 | Systematic Assessment |
|
| Right upper quadrant tumor pain flare | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v5.0 | Systematic Assessment |
|
| Tumor pain flare | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v5.0 | Systematic Assessment |
|
| Rash-face | Skin and subcutaneous tissue disorders | CTCAE v5.0 | Systematic Assessment |
|
| Diaphoresis | Skin and subcutaneous tissue disorders | CTCAE v5.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | CTCAE v5.0 | Systematic Assessment |
|
| Hyperpigmentation of bilateral fingernails | Skin and subcutaneous tissue disorders | CTCAE v5.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | CTCAE v5.0 | Systematic Assessment |
|
| Worsening hypertension | Vascular disorders | CTCAE v5.0 | Systematic Assessment |
|
| Intermittent hypotension | Vascular disorders | CTCAE v5.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE v5.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE v5.0 | Systematic Assessment |
|
| Worsening peripheral neuropathy | Nervous system disorders | CTCAE v5.0 | Systematic Assessment |
|
| Persistent change of taste | Nervous system disorders | CTCAE v5.0 | Systematic Assessment |
|
| Lightheadedness | Nervous system disorders | CTCAE v5.0 | Systematic Assessment |
|
| Left hydronephrosis | Renal and urinary disorders | CTCAE v5.0 | Systematic Assessment |
|
| Left ureteral wall thickening | Renal and urinary disorders | CTCAE v5.0 | Systematic Assessment |
|
| Right hydronephrosis | Renal and urinary disorders | CTCAE v5.0 | Systematic Assessment |
|
| Intermittent dysuria | Renal and urinary disorders | CTCAE v5.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE v5.0 | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE v5.0 | Systematic Assessment |
|
| Intermittent bilateral renal colic | Renal and urinary disorders | CTCAE v5.0 | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE v5.0 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE v5.0 | Systematic Assessment |
|
| Worsening diabetes mellitus type 2 | Metabolism and nutrition disorders | CTCAE v5.0 | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE v5.0 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | CTCAE v5.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE v5.0 | Systematic Assessment |
|
| Post surgical pain | Injury, poisoning and procedural complications | CTCAE v5.0 | Systematic Assessment |
|
| Hyperbilirubinemia (blood bilirubin increased) | Hepatobiliary disorders | CTCAE v5.0 | Systematic Assessment |
|
After the multicenter publication or 12 months after completion of the Study, whichever occurs first, Institution may itself publish the results of its data from the Study. Institution/Principal Investigator shall provide Sponsor/CRO with advance copy of any proposed publication/oral presentation sixty (60) days prior to the planned date of submission/presentation; Sponsor shall have 60 days to review the proposed publication/presentation.
| Cycle 1 Day 15 |
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| Cycle 2 Day 1 |
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| Cycle 1 Day 15 |
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| Cycle 2 Day 1 |
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| Cycle 1 Day 15 |
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| Cycle 1 Day 15 |
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| Cycle 2 Day 1 |
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| Cycle 1 Day 15 |
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| Cycle 2 Day 1 |
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