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| ID | Type | Description | Link |
|---|---|---|---|
| CP12-1029 | Other Identifier | ImClone Systems | |
| 14T-IE-JVBY | Other Identifier | Eli Lilly and Company |
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The primary objective of this study is to investigate the safety and tolerability of the anti-vascular endothelial growth factor receptor-2 (anti-VEGFR-2) monoclonal antibody Ramucirumab (IMC-1121B) in combination with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) in Japanese participants with advanced colorectal carcinoma (CRC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFIRI plus Ramucirumab (IMC-1121B) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramucirumab (IMC-1121B) | Biological | Ramucirumab (IMC-1121B): Intravenous (IV) infusions, 8 milligrams per kilogram (mg/kg) every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Experienced Any Dose-Limiting Toxicities (DLT) During the DLT Assessment Period | DLTs were adverse events (AEs) possibly related to study drug that met the National Cancer Institute's Common Terminology Criteria for AEs (NCI CTCAE, version 4.03): Grade 4 neutropenia ≥7 days or ≥Grade 3 with bacteremia or sepsis; Absolute neutrophil count <1.0x10^9/Liters with fever ≥38.3°Celsius requiring intravenous antibiotic therapy; Grade 4 thrombocytopenia or ≥Grade 3 with bleeding requiring platelet transfusion; ≥Grade 3 altered coagulation tests and no anticoagulation; ≥Grade 4 or uncontrolled hypertension; ≥Grade 3 non-hematologic toxicity (except non-clinically significant Grade 3 events like electrolyte abnormality, hypersensitivity, and arthralgia/myalgia); urine protein >3 grams/24 hours; study drug-related toxicity causing Cycle 3, Day 1 treatment delay until Day 44 or later. Grade 3 or Grade 4 infusion-related reaction (hypersensitivity) due to ramucirumab or FOLFIRI, not a DLT. | Day 1, Cycle 1 through Day 1, Cycle 3 (1 cycle=14 days) |
| Number of Participants With Ramucirumab Drug-Related Adverse Events or Serious Adverse Events | Data are presented for the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade ≥3 TEAEs, or adverse events (AEs) leading to discontinuation of treatment that were considered to be related to ramucirumab. Events related to Irinotecan, Levofolinate, and 5-fluorouracil (5-FU) were reported separately. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section. | Baseline to end of study (up to 49.3 weeks) plus 37 day follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serum Anti-IMC-1121B Antibodies (Immunogenicity) | Day 1 of Cycle 5 (Week 9), Cycle 6 (Week 11), Cycle 7 (Week 13), and Cycle 9 (Week 17) [(1 cycle=14 days)] | |
| Maximum Concentration (Cmax) of Ramucirumab | The Cmax of ramucirumab in serum on Day 1, Cycle 1 and on Day 1, Cycle 5, which was also considered Cmax at steady state (Cmax,ss), is reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ImClone Investigational Site | Chiba | 277-8577 | Japan | |||
| ImClone Investigational Site |
Eight (8) participants signed the informed consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | FOLFIRI Plus Ramucirumab (IMC-1121B) | Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks. Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety population: Participants who received any quantity of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | FOLFIRI Plus Ramucirumab (IMC-1121B) | Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks. Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision. |
| 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 | Number of Participants That Experienced Any Dose-Limiting Toxicities (DLT) During the DLT Assessment Period | DLTs were adverse events (AEs) possibly related to study drug that met the National Cancer Institute's Common Terminology Criteria for AEs (NCI CTCAE, version 4.03): Grade 4 neutropenia ≥7 days or ≥Grade 3 with bacteremia or sepsis; Absolute neutrophil count <1.0x10^9/Liters with fever ≥38.3°Celsius requiring intravenous antibiotic therapy; Grade 4 thrombocytopenia or ≥Grade 3 with bleeding requiring platelet transfusion; ≥Grade 3 altered coagulation tests and no anticoagulation; ≥Grade 4 or uncontrolled hypertension; ≥Grade 3 non-hematologic toxicity (except non-clinically significant Grade 3 events like electrolyte abnormality, hypersensitivity, and arthralgia/myalgia); urine protein >3 grams/24 hours; study drug-related toxicity causing Cycle 3, Day 1 treatment delay until Day 44 or later. Grade 3 or Grade 4 infusion-related reaction (hypersensitivity) due to ramucirumab or FOLFIRI, not a DLT. | DLT population: All enrolled participants who either completed the first 3 administrations of study medication or discontinued study medication due to a DLT during the DLT assessment period (Day 1, Cycle 1 through Day 1, Cycle 3). | Number | participants | Day 1, Cycle 1 through Day 1, Cycle 3 (1 cycle=14 days) |
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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 | FOLFIRI Plus Ramucirumab (IMC-1121B) | Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks. Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000096662 | Ramucirumab |
| D000077146 | Irinotecan |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Irinotecan | Drug | IV Infusion, 180 milligrams per square meter (mg/m²) every 2 weeks |
|
| levofolinate | Drug | IV infusion, 200 mg/m² every 2 weeks |
|
| 5-Fluorouracil (5-FU) | Drug | 400 mg/m² bolus followed by a 2400 mg/m² continuous infusion, every 2 weeks |
|
| Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days) |
| Area Under the Curve (AUC) of Ramucirumab | Reported for Day 1, Cycle 1 is AUC from time 0 extrapolated to infinity [AUC(0-inf)] and for Day 1, Cycle 5 is AUC over the dosing interval at steady state AUC(tau,ss). | Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days) |
| Half Life (t1/2) of Ramucirumab | t1/2 is the time required for the plasma/serum concentration to decrease 50%. | Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days) |
| Clearance (CL) of Ramucirumab | The total body CL of ramucirumab on Day 1, Cycle 1 and on Day 1, Cycle 5, which was also considered CL at steady state (CLss), is reported. | Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days) |
| Steady State Volume of Distribution (Vss) of Ramucirumab | Vss is the theoretical volume in which the total amount of study drug would need to be uniformly distributed during steady state to produce the same concentration as it is in plasma/serum. | Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days) |
| Best Overall Response [Anti-Tumor Activity of FOLFIRI Plus Ramucirumab (IMC-1121B)] | Best overall response evaluated using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Progressive Disease (PD): an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if that was the smallest on study). In addition, the sum must have demonstrated an absolute increase of at least 5 mm (the appearance of 1 or more new lesions was considered progression). Stable Disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. | Every 8 weeks until PD (up to 49 weeks) |
| Osaka |
| 569-8686 |
| Japan |
| ImClone Investigational Site | Shizuoka | 411-8777 | Japan |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) performance status | ECOG performance status classified participants according to their functional impairment. Scores ranged from 0 (fully active) to 5 (death). | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | FOLFIRI Plus Ramucirumab (IMC-1121B) | Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks. Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision. |
|
|
| Primary | Number of Participants With Ramucirumab Drug-Related Adverse Events or Serious Adverse Events | Data are presented for the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade ≥3 TEAEs, or adverse events (AEs) leading to discontinuation of treatment that were considered to be related to ramucirumab. Events related to Irinotecan, Levofolinate, and 5-fluorouracil (5-FU) were reported separately. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section. | Safety population: Participants who received any quantity of study medication. | Number | participants | Baseline to end of study (up to 49.3 weeks) plus 37 day follow-up |
|
|
|
| Secondary | Number of Participants With Serum Anti-IMC-1121B Antibodies (Immunogenicity) | Participants who received any quantity of study medication and had evaluable immunogenicity data at the specified time points. | Number | participants | Day 1 of Cycle 5 (Week 9), Cycle 6 (Week 11), Cycle 7 (Week 13), and Cycle 9 (Week 17) [(1 cycle=14 days)] |
|
|
|
| Secondary | Maximum Concentration (Cmax) of Ramucirumab | The Cmax of ramucirumab in serum on Day 1, Cycle 1 and on Day 1, Cycle 5, which was also considered Cmax at steady state (Cmax,ss), is reported. | Participants who received any quantity of study medication and had evaluable Cmax data at the specified time points. | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (mcg/mL) | Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days) |
|
|
|
| Secondary | Area Under the Curve (AUC) of Ramucirumab | Reported for Day 1, Cycle 1 is AUC from time 0 extrapolated to infinity [AUC(0-inf)] and for Day 1, Cycle 5 is AUC over the dosing interval at steady state AUC(tau,ss). | Participants who received any quantity of study medication and had evaluable AUC data at the specified time points. | Geometric Mean | Geometric Coefficient of Variation | micrograms*day/milliliter (mcg*day/mL) | Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days) |
|
|
|
| Secondary | Half Life (t1/2) of Ramucirumab | t1/2 is the time required for the plasma/serum concentration to decrease 50%. | Participants who received any quantity of study medication and had evaluable t1/2 data at the specified time points. | Geometric Mean | Geometric Coefficient of Variation | days | Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days) |
|
|
|
| Secondary | Clearance (CL) of Ramucirumab | The total body CL of ramucirumab on Day 1, Cycle 1 and on Day 1, Cycle 5, which was also considered CL at steady state (CLss), is reported. | Participants who received any quantity of study medication and had evaluable CL data at the specified time points. | Geometric Mean | Geometric Coefficient of Variation | milliliters per hour (mL/hr) | Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days) |
|
|
|
| Secondary | Steady State Volume of Distribution (Vss) of Ramucirumab | Vss is the theoretical volume in which the total amount of study drug would need to be uniformly distributed during steady state to produce the same concentration as it is in plasma/serum. | Participants who received any quantity of study medication and had evaluable Vss data at the specified time points. | Geometric Mean | Geometric Coefficient of Variation | Liters (L) | Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days) |
|
|
|
| Secondary | Best Overall Response [Anti-Tumor Activity of FOLFIRI Plus Ramucirumab (IMC-1121B)] | Best overall response evaluated using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Progressive Disease (PD): an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if that was the smallest on study). In addition, the sum must have demonstrated an absolute increase of at least 5 mm (the appearance of 1 or more new lesions was considered progression). Stable Disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. | Safety population: Participants who received any quantity of study medication. | Number | participants | Every 8 weeks until PD (up to 49 weeks) |
|
|
|
| 0 |
| 6 |
| 6 |
| 6 |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| CHEILITIS | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| GINGIVITIS | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| LOWER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| MOUTH HAEMORRHAGE | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| PERIODONTAL DISEASE | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| FACE OEDEMA | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| FEELING ABNORMAL | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| INFUSION RELATED REACTION | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| MALAISE | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| OEDEMA | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| SKIN INJURY | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| BLOOD CREATININE INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPOPROTEINAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| PRESYNCOPE | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| PROTEINURIA | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| UTERINE HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| HICCUPS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| Title | Measurements |
|---|---|
|
| Related AE leading to discontinuation |
|
| Title | Measurements |
|---|---|
|
| Day 1, Cycle 9 (n=4) |
|
| Title | Measurements |
|---|---|
|
| Progressive Disease (PD) |
|