Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK1697-001 | Other Identifier | Merck |
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Business Reasons
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The purpose of this study is to evaluate the safety and preliminary efficacy of MK-1697. There are 2 parts in this study: dose escalation to determine the recommended phase 2 dose (RP2D) and confirm the RP2D (Part A) and cohort expansion to determine preliminary efficacy in participants with colorectal cancer (CRC) or head and neck squamous cell cancer (HNSCC) (Part B). No formal hypothesis testing will be done in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: MK-1696 20 mg | Experimental | Participants received 20 mg of MK-1697 by intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years). |
|
| Part A: MK-1697 65 mg | Experimental | Participants received 65 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years). |
|
| Part A: MK-1697 200 mg | Experimental | Participants received 200 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years). |
|
| Part B: Expansion Cohort | Experimental | Participants with select tumor types were to receive MK-1697 at the RP2D by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-1697 | Biological | Administered by IV infusion on Day 1 of each 21-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1 | The following toxicities were considered a DLT, if assessed as related to study treatment: Grade (Gr) 4 non-hematologic toxicity (T); Gr 4 hematologic T for ≥7 days; Gr 4 thrombocytopenia; Gr 3 thrombocytopenia with bleeding; ≥Gr 3 non-hematologic clinical AE except fatigue for ≤3 days, Gr 3 nausea, vomiting, or diarrhea for >72 hours despite anti-emetics/diarrheals, or other supportive care; Gr 3 rash without corticosteroids/anti-inflammatory agents use per standard of care; Gr 3/4 non-hematologic laboratory value if: medical intervention is required, abnormality leads to hospitalization, persists for >1 week, or abnormality results in drug-induced liver injury; Gr 3 or 4 febrile neutropenia; treatment-related T causing discontinuation; inability to administer ≥75% of planned dose due to drug-related tolerability; Gr 5 T; delay in Cycle 2 start by >2 weeks due to T. Pool-adjacent violators algorithm was used to estimate DLT rate & Bayesian method for 80% confidence intervals (CIs). | Up to 21 days of Cycle 1 (cycle length = 21 days) |
| Number of Participants Who Experienced At Least One Adverse Event (AE) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experienced at least one AE were presented. | Up to approximately 9 months |
| Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinued study intervention due to an AE were presented. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) | An objective response was defined as a complete response (CR: Disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the investigator based on RECIST 1.1 following administration of MK-1697. ORR was reported as percentage of participants who experienced an CR or PR after administration of MK-1967. The exact method based on the binomial distribution (Clopper-Pearson interval) was used to estimate ORR and its associated 95%CIs. |
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Inclusion Criteria:
For Part A; has a histologically- or cytologically-confirmed advanced/metastatic solid tumor and has received, been intolerant to, or been ineligible for all treatments known to confer clinical benefit
For Part B: has 1 of the following histologically or cytologically confirmed tumor types that are anti-programmed cell death protein 1 (anti PD-1)/anti-programmed death-ligand 1 (anti PD-L1) treatment naive:
Has measurable disease by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Has an evaluable baseline tumor sample (either a recent or archival) for analysis
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Has central venous access (eg, portacath, Hickman line, or peripherally inserted central catheter [PICC] line) currently inserted or be considered medically fit for and willing to undergo the insertion of such a device
Is not pregnant or breastfeeding
Female participants of childbearing potential must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment
Male participants must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientia Clinical Research ( Site 0100) | Randwick | New South Wales | 2031 | Australia | ||
| Queen Mary Hospital ( Site 0200) |
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All 22 participants allocated received study treatment (All Treated Population) and were evaluable for all safety analysis. Expansion Cohort (Part B) did not enroll any participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: MK-1697 20 mg | Participants received 20 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years). |
| FG001 | Part A: MK-1697 65 mg | Participants received 65 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years). |
| FG002 | Part A: MK-1697 200 mg | Participants received 200 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years). |
| FG003 | Part B: Expansion Cohort | Participants with select tumor types were to receive MK-1697 at the RP2D by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years). No participants were enrolled in this arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
No participants were enrolled in Part B since study was terminated at the completion of Part A.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: MK-1697 20 mg | Participants received 20 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years). |
| BG001 | Part A: MK-1697 65 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1 | The following toxicities were considered a DLT, if assessed as related to study treatment: Grade (Gr) 4 non-hematologic toxicity (T); Gr 4 hematologic T for ≥7 days; Gr 4 thrombocytopenia; Gr 3 thrombocytopenia with bleeding; ≥Gr 3 non-hematologic clinical AE except fatigue for ≤3 days, Gr 3 nausea, vomiting, or diarrhea for >72 hours despite anti-emetics/diarrheals, or other supportive care; Gr 3 rash without corticosteroids/anti-inflammatory agents use per standard of care; Gr 3/4 non-hematologic laboratory value if: medical intervention is required, abnormality leads to hospitalization, persists for >1 week, or abnormality results in drug-induced liver injury; Gr 3 or 4 febrile neutropenia; treatment-related T causing discontinuation; inability to administer ≥75% of planned dose due to drug-related tolerability; Gr 5 T; delay in Cycle 2 start by >2 weeks due to T. Pool-adjacent violators algorithm was used to estimate DLT rate & Bayesian method for 80% confidence intervals (CIs). | All Part A participants who received at least 1 dose of study treatment and finished Cycle 1 without a DLT or experienced a DLT in Cycle 1. | Posted | Count of Participants | Participants | Up to 21 days of Cycle 1 (cycle length = 21 days) |
Non-serious AEs were collected for up to approximately 9 months. All-cause mortality and serious AEs were collected for up to approximately 14 months.
All-Cause Mortality reported for all enrolled participants. Serious AEs and Other AEs were reported for all enrolled participants who received at least 1 dose of study treatment. No participants were enrolled in Part B since study was terminated at the completion of Part A.
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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 | Part A: MK-1697 20 mg | Participants received 20 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
The study was terminated due to business reasons.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
Not provided
| 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 | May 23, 2019 | Jan 26, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Up to approximately 8 months |
| Up to approximately 18 months (through End of Trial data cut-off 18 Feb 2020) |
| Objective Response Rate (ORR) Per Modified Response Evaluation Criteria In Solid Tumors Version 1.1 for Immune-based Therapeutics (iRECIST) | An objective response was defined as an immune-based complete response (iCR: Disappearance of all target lesions) or immune-based partial response (iPR: At least a 30% decrease in the sum of diameters of target lesions). ORR was reported as percentage of participants who experienced an iCR or iPR after administration of MK-1967. Participants were initially assessed for progressive disease (PD : ≥20% increase in sum of diameters [SD] of target lesions or relative increase of 20%, sum must demonstrate an absolute increase of ≥5 mm or appearance of one/more new lesions) per RECIST 1.1 by local site investigator; later verified by central imaging vendor. Investigator could elect to continue treatment and tumor assessment repeated 4-8 weeks later to confirm PD by iRECIST. The exact method based on the binomial distribution (Clopper-Pearson interval) was used to estimate ORR and its associated 95%CIs. | Up to approximately 18 months (through End of Trial data cut-off 18 Feb 2020) |
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC 0-inf) of MK-1697 | Serum samples were collected at specified time points for determination of MK-1697 AUC 0-inf. AUC 0-inf was defined as the area under the concentration-time curve of MK-1697 from time zero to infinity for all participants in Part A for each dose group. | Cycle 1-3: Days 1, 2 (only Cycle 1), 3, 8, 15 - predose and postdose at 10 minutes, 2 hours (cycle length = 21 days) |
| Area Under the Concentration Time Curve From Time Zero to Last Concentration (AUC 0-last) Measured of MK-1697 | Serum samples were collected at specified time points for determination of AUC 0-last of MK-1697. AUC 0-last was defined as the area under the concentration-time curve of MK-1697 from time zero to the last concentration of MK-1697 measured for all participants in Part A for each dose group. | Cycles 1, 2, and 3: predose, 10 minutes and 2 hours post-dose (cycle length = 21 days) |
| Maximum Serum Concentration (Cmax) of MK-1697 | Serum samples were collected at specified time points for determination of MK-1697 Cmax. Cmax was defined as the maximum concentration of MK-1697 reached for all participants in Part A for each dose group. | Cycle 1-3: Days 1, 2 (only Cycle 1), 3, 8, 15 - predose and postdose at 10 minutes, 2 hours (cycle length = 21 days) |
| Minimum Serum Concentration (Cmin) of MK-1697 | Serum samples were collected pre-dose at specified time points (Cycles 1, 2, 3, 5, 7, and 11) for the determination of MK-1697 Ctrough (may also be referred to as Cmin) per protocol. Ctrough was defined as the lowest concentration of MK-1697 reached before the next dose was administered. Serum Ctrough of MK-1697 was reported for all participants in Part A for each dose group. | Cycles 1-3, 5, 7, 11: Days 1, 2 (only Cycle 1), 3, 8, 15 - predose and postdose at 10 minutes, 2 hours (cycle length = 21 days) |
| Hong Kong |
| Hong Kong |
| Lost to Follow-up |
|
| Study terminated by sponsor |
|
| Status not recorded |
|
Participants received 65 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years).
| BG002 | Part A: MK-1697 200 mg | Participants received 200 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years). |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Part A: MK-1697 20 mg | Participants received 20 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years). |
| OG001 | Part A: MK-1697 65 mg | Participants received 65 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years). |
| OG002 | Part A: MK-1697 200 mg | Participants received 200 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years). |
|
|
|
| Primary | Number of Participants Who Experienced At Least One Adverse Event (AE) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experienced at least one AE were presented. | All Part A participants who received at least one dose of study treatment. Expansion Cohort (Part B) did not enroll any participants. | Posted | Count of Participants | Participants | Up to approximately 9 months |
|
|
|
| Primary | Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinued study intervention due to an AE were presented. | All Part A participants who received at least one dose of study treatment. Expansion Cohort (Part B) did not enroll any participants. | Posted | Count of Participants | Participants | Up to approximately 8 months |
|
|
|
| Secondary | Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) | An objective response was defined as a complete response (CR: Disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the investigator based on RECIST 1.1 following administration of MK-1697. ORR was reported as percentage of participants who experienced an CR or PR after administration of MK-1967. The exact method based on the binomial distribution (Clopper-Pearson interval) was used to estimate ORR and its associated 95%CIs. | All Part A participants with a baseline scan that demonstrated measurable disease by the investigator's assessment, and who received at least 1 dose of study treatment were evaluated. Expansion Cohort (Part B) did not enroll any participants. | Posted | Number | Percentage of Participants | Up to approximately 18 months (through End of Trial data cut-off 18 Feb 2020) |
|
|
|
|
| Secondary | Objective Response Rate (ORR) Per Modified Response Evaluation Criteria In Solid Tumors Version 1.1 for Immune-based Therapeutics (iRECIST) | An objective response was defined as an immune-based complete response (iCR: Disappearance of all target lesions) or immune-based partial response (iPR: At least a 30% decrease in the sum of diameters of target lesions). ORR was reported as percentage of participants who experienced an iCR or iPR after administration of MK-1967. Participants were initially assessed for progressive disease (PD : ≥20% increase in sum of diameters [SD] of target lesions or relative increase of 20%, sum must demonstrate an absolute increase of ≥5 mm or appearance of one/more new lesions) per RECIST 1.1 by local site investigator; later verified by central imaging vendor. Investigator could elect to continue treatment and tumor assessment repeated 4-8 weeks later to confirm PD by iRECIST. The exact method based on the binomial distribution (Clopper-Pearson interval) was used to estimate ORR and its associated 95%CIs. | All Part A participants that demonstrated PD by RECIST 1.1 per investigator's assessment, who received at least 1 dose of study treatment and were complaint with study procedures. Expansion Cohort (Part B) did not enroll any participants. | Posted | Number | Percentage of Participants | Up to approximately 18 months (through End of Trial data cut-off 18 Feb 2020) |
|
|
|
|
| Secondary | Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC 0-inf) of MK-1697 | Serum samples were collected at specified time points for determination of MK-1697 AUC 0-inf. AUC 0-inf was defined as the area under the concentration-time curve of MK-1697 from time zero to infinity for all participants in Part A for each dose group. | All Part A participants who were compliant with the study procedures and have AUC 0-inf data available from at least one treatment. Participants vary across cycles due to availability of adequate data to allow computation of AUC 0-inf in each cycle based on compliance with study procedures. Expansion Cohort (Part B) did not enroll any participants. | Posted | Geometric Mean | Geometric Coefficient of Variation | Day*ng/mL | Cycle 1-3: Days 1, 2 (only Cycle 1), 3, 8, 15 - predose and postdose at 10 minutes, 2 hours (cycle length = 21 days) |
|
|
|
| Secondary | Area Under the Concentration Time Curve From Time Zero to Last Concentration (AUC 0-last) Measured of MK-1697 | Serum samples were collected at specified time points for determination of AUC 0-last of MK-1697. AUC 0-last was defined as the area under the concentration-time curve of MK-1697 from time zero to the last concentration of MK-1697 measured for all participants in Part A for each dose group. | All Part A participants who were compliant with the study procedures and have AUC 0-last data available from at least one treatment. Participants vary across cycles due to availability of adequate data to allow computation of AUC 0-last in each cycle based on compliance with study procedures. Expansion Cohort (Part B) did not enroll any participants. | Posted | Geometric Mean | Geometric Coefficient of Variation | Day*ng/mL | Cycles 1, 2, and 3: predose, 10 minutes and 2 hours post-dose (cycle length = 21 days) |
|
|
|
| Secondary | Maximum Serum Concentration (Cmax) of MK-1697 | Serum samples were collected at specified time points for determination of MK-1697 Cmax. Cmax was defined as the maximum concentration of MK-1697 reached for all participants in Part A for each dose group. | All Part A participants who were compliant with the study procedures and have Cmax data available from at least one treatment. Participants vary across cycles due to early discontinuation and not completing planned assessments. Expansion Cohort (Part B) did not enroll any participants. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Cycle 1-3: Days 1, 2 (only Cycle 1), 3, 8, 15 - predose and postdose at 10 minutes, 2 hours (cycle length = 21 days) |
|
|
|
| Secondary | Minimum Serum Concentration (Cmin) of MK-1697 | Serum samples were collected pre-dose at specified time points (Cycles 1, 2, 3, 5, 7, and 11) for the determination of MK-1697 Ctrough (may also be referred to as Cmin) per protocol. Ctrough was defined as the lowest concentration of MK-1697 reached before the next dose was administered. Serum Ctrough of MK-1697 was reported for all participants in Part A for each dose group. | All Part A participants who were compliant with the study procedures and have Cmin data available from at least one treatment. Participants vary across cycles due to early discontinuation and not completing planned assessments. Expansion Cohort (Part B) did not enroll any participants. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Cycles 1-3, 5, 7, 11: Days 1, 2 (only Cycle 1), 3, 8, 15 - predose and postdose at 10 minutes, 2 hours (cycle length = 21 days) |
|
|
|
| 3 |
| 3 |
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | Part A: MK-1697 65 mg | Participants received 65 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years). | 2 | 4 | 1 | 4 | 4 | 4 |
| EG002 | Part A: MK-1697 200 mg | Participants received 200 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years). | 6 | 15 | 7 | 15 | 14 | 15 |
| Adrenal insufficiency | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypothermia | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Pulmonary sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
|
| Nephropathy toxic | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Change of bowel habit | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Conjunctivitis viral | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Stoma site infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Device occlusion | Product Issues | MedDRA 23.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
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| Menstruation irregular | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
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The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| Objective Response Rate (ORR) |
| 0.0 |
| 2-Sided |
| 95 |
| 0.0 |
| 60.2 |
| Other |
Clopper Pearson confidence interval method for binomial data |
| Objective Response Rate (ORR) | 0.0 | 2-Sided | 95 | 0.0 | 21.8 | Other | Clopper Pearson confidence interval method for binomial data |
| Objective Response Rate (ORR) |
| 0.0 |
| 2-Sided |
| 95 |
| 0.0 |
| 70.8 |
| Other |
Clopper Pearson confidence interval method for binomial data |
| Objective Response Rate )ORR) | 0.0 | 2-Sided | 95 | 0.0 | 28.5 | Other | Clopper Pearson confidence interval method for binomial data |
| Cycle 2 |
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| Cycle 2 |
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| Cycle 3 |
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| Cycle 2 |
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| Cycle 3 |
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| Cycle 2 |
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| Cycle 5 |
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| Cycle 7 |
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| Cycle 11 |
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