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| ID | Type | Description | Link |
|---|---|---|---|
| MK1775-005 | Other Identifier | Merck Registration Number |
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The study has been terminated due to business reasons.
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The study evaluates safety of adavosertib in monotherapy, and in combination with 5-Fluorouracil (5-FU) alone or with 5-FU/cis-diamminedichloroplatinum (CDDP) in Japanese participants with solid tumor. The primary hypothesis is that adavosertib is safe and tolerable in participants with locally advanced or metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: adavosertib 65 mg BID | Experimental | Participants received 65 mg of adavosertib administered orally twice a day (BID) on Days 1-5 of a 21-day cycle. |
|
| Part 2 A1: adavosertib 20 mg BID+5-FU 1000 mg | Experimental | Participants received 20 mg of adavosertib administered orally BID on Days 1-5 of a 21-day cycle and 1000 mg/m^2/day of 5-FU administered as an intravenous (IV) infusion on Days 1-4 of a 21-day cycle. |
|
| Part 2 A2: adavosertib 20 mg QD+5-FU 1000 mg | Experimental | Participants received 20 mg of adavosertib administered orally once a day (QD) on Days 1-5 of a 21-day cycle and 1000 mg/m^2/day of 5-FU administered as an IV infusion on Days 1-4 of a 21-day cycle. |
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| Parts 2B +3: adavosertib+5-FU+CDDP | Experimental | Participants were to receive 20 mg or 65 mg of adavosertib administered either BID or QD on Days 1-5 of a 21-day cycle; 1000 mg/m^2/day of 5-FU administered as an IV infusion on Days 1-4 of a 21-day cycle; and 60 mg/m^2 to 100 mg/m^2 of CDDP administered as an IV infusion on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adavosertib 20 mg | Drug | Adavosertib 20 mg capsule administered orally on days 1-5 of a 21 day cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | DLT was defined using National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 and included: any drug-related hematologic toxicity ≥Grade 4 with the exception of Grade 4 neutropenia <7 days duration; Grade 3 or 4 neutropenia with fever >38.5 degrees Celsius and/or infection or neutropenia requiring colony-stimulating factor OR non-hematologic DLTs that were any Grade 3, 4, or 5 toxicity with the following exceptions: Grade 3 nausea, vomiting, diarrhea, and dehydration occurring in a setting of inadequate treatment; inadequately treated hypersensitivity reactions; Grade 3 elevated transaminases or urine electrolyte abnormality ≤1 week in duration; Grade 3 serum electrolyte abnormality ≤72 hours in duration. DLTs also included: drug-related adverse experience that lead to a dose modification; unresolved drug-related toxicity preventing treatment for ≥3 weeks or preventing administration of ≥8 of 10 doses in Parts 1 or 2A1 or 4 of 5 doses in Part 2A2. | Cycle 1 (21 days) |
| Maximum Tolerated Dose (MTD) of MK1775 in Combination With 5-FU/CDDP Determined by Number of DLTs Per Dose Level: Locally Advanced or Metastatic Esophageal, Head and Neck, or Gastric Cancer | The maximum tolerated dose (MTD) of MK-1775 in combination with 5-FU/CDDP for participants with locally advanced or metastatic esophageal, head and neck, or gastric cancer was determined based on DLTs that occurred during Cycle 1 of Parts 2B and 3. The MTD for MK-1775 in combination with 5-FU/CDDP was defined as the dose level at which approximately 30% of the participants were expected to experience a DLT for the combination therapy. The study was terminated early and Parts 2B and 3 were not performed. No participants received the 5-FU/CDDP regimen therefore the MTD for MK-1775 in combination with 5-FU/CDDP was not established. | Cycle 1 (21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| MTD of MK1775 in Combination With 5-FU/CDDP Determined by Number of DLTs Per Dose Level: Locally Advanced or Metastatic Solid Tumors | The maximum tolerated dose (MTD) of MK-1775 in combination with 5-FU/CDDP for participants with locally advanced or metastatic solid tumors was determined based on DLTs that occurred during Cycle 1 of Parts 2B and 3. The MTD for MK-1775 in combination with 5-FU/CDDP was defined as the dose level at which approximately 30% of the participants were expected to experience a DLT for the combination therapy. The study was terminated early and Parts 2B and 3 were not performed. No participants received the 5-FU/CDDP regimen therefore the MTD for MK-1775 in combination with 5-FU/CDDP was not established. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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Participants received MK-1775 (Part 1), MK-1775 + 5-Fluorouracil (Part 2A), and MK-1775 + 5-Fluorouracil and cis-diamminedichloroplatinum (Parts 2B and 3). The study was terminated early and Parts 2B and 3 were not performed. No participants received the 5-Fluorouracil (5-FU) and cis-diamminedichloroplatinum (CDDP) regimen.
This study enrolled participants with a confirmed locally advanced or metastatic solid tumor failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Additional inclusion and exclusion criteria applied.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: MK-1775 65 mg BID | Participants received 65 mg of MK-1775 administered orally twice a day (BID) on Days 1-5 of a 21-day cycle. |
| FG001 | Part 2 A1: MK-1775 20 mg BID + 5-FU 1000 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 5-FU 1000 mg/m^2/day | Drug | 5-FU 1000 mg/m^2/day administered as an intravenous (IV) infusion on Days 1-4 of a 21-day cycle |
|
| CDDP | Drug | CDDP 60 mg/m^2 to 100 mg/m^2 administered as an IV infusion on Day 1. |
|
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| adavosertib 65 mg | Drug | Adavosertib 65 mg capsule administered orally on days 1-5 of a 21 day cycle. |
|
|
| Cycle 1 (21 days) |
Participants received 20 mg of MK-1775 administered orally BID on Days 1-5 of a 21-day cycle and 1000 mg/m^2/day of 5-FU administered as an intravenous (IV) infusion on Days 1-4 of a 21-day cycle.
| FG002 | Part 2 A2: MK-1775 20 mg QD + 5-FU 1000 mg | Participants received 20 mg of MK-1775 administered orally once a day (QD) on Days 1-5 of a 21-day cycle and 1000 mg/m^2/day of 5-FU administered as an IV infusion on Days 1-4 of a 21-day cycle. |
| FG003 | Parts 2B +3: MK-1775 + 5-FU + CDDP | Participants were to receive 20 mg or 65 mg of MK-1775 administered either BID or QD on Days 1-5 of a 21-day cycle; 1000 mg/m^2/day of 5-FU administered as an IV infusion on Days 1-4 of a 21-day cycle; and 60 mg/m^2 to 100 mg/m^2 of CDDP administered as an IV infusion on Day 1. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: MK-1775 65 mg BID | Participants received 65 mg of MK-1775 administered orally twice a day (BID) on Days 1-5 of a 21-day cycle. |
| BG001 | Part 2 A1: MK-1775 20 mg BID + 5-FU 1000 mg | Participants received 20 mg of MK-1775 administered orally BID on Days 1-5 of a 21-day cycle and 1000 mg/m^2/day of 5-FU administered as an intravenous (IV) infusion on Days 1-4 of a 21-day cycle. |
| BG002 | Part 2 A2: MK-1775 20 mg QD + 5-FU 1000 mg | Participants received 20 mg of MK-1775 administered orally once a day (QD) on Days 1-5 of a 21-day cycle and 1000 mg/m^2/day of 5-FU administered as an IV infusion on Days 1-4 of a 21-day cycle. |
| BG003 | Parts 2B +3: MK-1775 + 5-FU + CDDP | Participants were to receive 20 mg or 65 mg of MK-1775 administered either BID or QD on Days 1-5 of a 21-day cycle; 1000 mg/m^2/day of 5-FU administered as an IV infusion on Days 1-4 of a 21-day cycle; and 60 mg/m^2 to 100 mg/m^2 of CDDP administered as an IV infusion on Day 1. |
| BG004 | 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 | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| ECOG Performance Status | The ECOG scale of performance status is a measurement of how the disease impacts the daily living abilities of the participant. It describes a participant's level of functioning in terms of their ability to care for themself, daily activity, and physical ability. The scale ranges from 0 (fully active) to 5 (dead). The study required participants to have a score of 0 (fully active, able to carry on all pre-disease performance without restriction) or 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature). | Number | Participants |
| |||||||||||||||
| Number of Prior Chemotherapy Regimens | The study required participants to have a solid tumor that failed to respond to standard therapy or progressed despite standard therapy as demonstrated by the number of prior chemotherapy regimens received. | Mean | Standard Deviation | Prior regimens |
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| 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 With Dose Limiting Toxicities (DLTs) | DLT was defined using National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 and included: any drug-related hematologic toxicity ≥Grade 4 with the exception of Grade 4 neutropenia <7 days duration; Grade 3 or 4 neutropenia with fever >38.5 degrees Celsius and/or infection or neutropenia requiring colony-stimulating factor OR non-hematologic DLTs that were any Grade 3, 4, or 5 toxicity with the following exceptions: Grade 3 nausea, vomiting, diarrhea, and dehydration occurring in a setting of inadequate treatment; inadequately treated hypersensitivity reactions; Grade 3 elevated transaminases or urine electrolyte abnormality ≤1 week in duration; Grade 3 serum electrolyte abnormality ≤72 hours in duration. DLTs also included: drug-related adverse experience that lead to a dose modification; unresolved drug-related toxicity preventing treatment for ≥3 weeks or preventing administration of ≥8 of 10 doses in Parts 1 or 2A1 or 4 of 5 doses in Part 2A2. | The DLT-evaluable population consisted of participants who received at least one dose of MK-1775 and completed Cycle 1 of Parts 1, 2A1, 2A2, or discontinued due to toxicity. | Posted | Number | Participants | Cycle 1 (21 days) |
|
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| Primary | Maximum Tolerated Dose (MTD) of MK1775 in Combination With 5-FU/CDDP Determined by Number of DLTs Per Dose Level: Locally Advanced or Metastatic Esophageal, Head and Neck, or Gastric Cancer | The maximum tolerated dose (MTD) of MK-1775 in combination with 5-FU/CDDP for participants with locally advanced or metastatic esophageal, head and neck, or gastric cancer was determined based on DLTs that occurred during Cycle 1 of Parts 2B and 3. The MTD for MK-1775 in combination with 5-FU/CDDP was defined as the dose level at which approximately 30% of the participants were expected to experience a DLT for the combination therapy. The study was terminated early and Parts 2B and 3 were not performed. No participants received the 5-FU/CDDP regimen therefore the MTD for MK-1775 in combination with 5-FU/CDDP was not established. | Participants who received at least one dose of MK-1775 in combination with 5-FU/CDDP and completed Cycle 1 of Parts 2B and 3. No participants received the 5-FU/CDDP regimen due to early termination of the study. | Posted | Cycle 1 (21 days) |
|
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| Secondary | MTD of MK1775 in Combination With 5-FU/CDDP Determined by Number of DLTs Per Dose Level: Locally Advanced or Metastatic Solid Tumors | The maximum tolerated dose (MTD) of MK-1775 in combination with 5-FU/CDDP for participants with locally advanced or metastatic solid tumors was determined based on DLTs that occurred during Cycle 1 of Parts 2B and 3. The MTD for MK-1775 in combination with 5-FU/CDDP was defined as the dose level at which approximately 30% of the participants were expected to experience a DLT for the combination therapy. The study was terminated early and Parts 2B and 3 were not performed. No participants received the 5-FU/CDDP regimen therefore the MTD for MK-1775 in combination with 5-FU/CDDP was not established. | Participants who received at least one dose of MK-1775 in combination with 5-FU/CDDP and completed Cycle 1 of Parts 2B and 3. No participants received the 5-FU/CDDP regimen due to early termination of the study. | Posted | Cycle 1 (21 days) |
|
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From first dose of MK-1775 alone or in combination with 5-FU through follow-up; up to 7 months
AEs for all participants who received at least one dose of MK-1775 alone or in combination with 5-FU.
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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 1: MK-1775 65 mg BID | Participants received 65 mg of MK-1775 administered orally twice a day (BID) on Days 1-5 of a 21-day cycle. | 0 | 3 | 3 | 3 | ||
| EG001 | Part 2 A1: MK-1775 20 mg BID + 5-FU 1000 mg | Participants received 20 mg of MK-1775 administered orally BID on Days 1-5 of a 21-day cycle and 1000 mg/m^2/day of 5-FU administered as an intravenous (IV) infusion on Days 1-4 of a 21-day cycle. | 2 | 6 | 6 | 6 | ||
| EG002 | Part 2 A2: MK-1775 20 mg QD + 5-FU 1000 mg | Participants received 20 mg of MK-1775 administered orally once a day (QD) on Days 1-5 of a 21-day cycle and 1000 mg/m^2/day of 5-FU administered as an IV infusion on Days 1-4 of a 21-day cycle. | 1 | 2 | 1 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pulmonary fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Cheilitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Gingival bleeding | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Activated partial thromboplastin time prolonged | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Blood creatine phosphokinase MB increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Blood urea increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Electrocardiogram ST-T segment depression | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| International normalised ratio increased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hyperammonaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypercreatinaemia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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Study terminated due to business reasons. Study Parts 2B and 3 were not done.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
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| ID | Term |
|---|---|
| C549567 | adavosertib |
| D005472 | Fluorouracil |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Male |
|
| ECOG Score = 1 |
|
| Participants |
|
|