Not provided
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Strategic decision, which is unrelated to safety
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The purpose of this study is to determine the maximum tolerated dose (MTD) of poly (ADP-Ribose) polymerase inhibitor E7016 when used with temozolomide (TMZ) in patients with advanced solid tumors and gliomas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E7016 + TMZ | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E7016 + TMZ | Drug | Single-Dose PK Period (single oral dose of E7016 on Day -7) in the Dose-Escalation Component; Multiple-Dose Treatment Cycles (7 days of oral E7016 + 5 days of oral TMZ) added in Cycle 1 of the Dose-Escalation Component and in Cycles 1 through 6 of the Expansion Component. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) for E7016 in Combination With Temozolomide | The MTD was defined as the highest dose of E7016 in combination with temozolomide at which no more than one of six participants experienced a dose-limiting toxicity (DLT). DLTs were defined as those adverse events (AEs) considered related to E7016 which occurred during the first cycle of study drug administration. DLTs were evaluated and graded based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version [v] 4.0). | Cycle 1 (Cycle length = 28 days) |
| Number of Participants With Dose-limiting Toxicity (DLT) | A DLT was defined as those AEs considered related to E7016 which occurred during the first cycle of study drug administration. DLTs were evaluated and graded based on the NCI CTCAE version 4.0. The following toxicities were regarded as DLTs: a Grade 4 hematologic toxicity (lasting [greater than or equal to] >=5 days); a temozolomide dose reduction for Grade >=3 neutropenia or thrombocytopenia; or a Grade >=3 nonhematologic toxicity (except optimally managed nausea, vomiting, or diarrhea) that was assessed by the investigator as related to study drug. A participant with two or more DLTs with the same preferred term was counted only once for that preferred term. | Cycle 1 (Cycle length = 28 days) |
| Alternative Dose of Interest (ADI) for E7016 in Combination With Temozolomide | The ADI determination plan was based primarily on clinical, and/or PK measurements of drug concentration and/or bioactivity as defined by preclinical studies. However, the ADI was not pursued due to the limited sample size. | Cycle 1 (Cycle length = 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The ORR was defined as the percentage of participants with complete response (CR) plus partial response (PR) as determined by the investigator, using modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in the evaluation of magnetic resonance imaging/computerized tomography (MRI/CT) scans of targeted lesions and photographs and bone scans if appropriate for the tumor type. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions. ORR = CR + PR |
Not provided
Inclusion Criteria:
Subjects who meet all of the following criteria may be included in the study.
Histopathologically confirmed melanoma or other solid tumors (excluding malignant brain tumors) for which no standard therapy is available (Dose-Escalation Component only). During the Expansion Component, enrollment will be restricted to subjects with histopathologically proven gliomas and will include subjects eligible for TMZ therapy as well as those who have failed TMZ therapy; and those who are either not appropriate candidates for radiation therapy or who refuse radiation therapy. Subjects who are taking either strong cytochrome P450 (CYP) inhibitors or inducers may be enrolled.
Life expectancy greater than or equal to 3 months after starting E7016.
Performance status (PS) 1 to 2 on the Eastern Cooperative Oncology Group (ECOG) scale.
Adequate renal function indicated by serum creatinine less than 1.5 mg/dL or calculated creatinine clearance greater than 50 mL/minute.
Adequate bone marrow reserve:
Adequate liver function:
Males and females age greater than or equal to 18 years at the time of informed consent.
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from participation in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Eisai Medical Services | Eisai Medical Services | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston | Massachusetts | United States | ||||
A total of 13 participants were screened, of which 1 was screen failure and 12 were enrolled to receive study treatment in Dose Escalation Part. The study was terminated due to sponsor's strategic decision, which is unrelated to safety, therefore no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Participants took part in the study at 2 investigative sites in the United States from 29 March 2010 to 24 February 2011.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 | Participants received single oral dose of 4 milligrams per kilogram per day (mg/kg/day) E7016 capsule on Day -7 for pharmacokinetic (PK) analysis, followed by once daily dose from days 1 to 5 in combination with temozolomide 150 milligrams per square meter (mg/m^2) capsule and alone on days 6 and 7 of Cycle 1 (cycle length=28 days) in Treatment Phase. Participants who completed the Treatment Phase entered the Extension Phase of Dose Escalation Part and continued the treatment in Extension Phase in same manner of Treatment Phase until unacceptable toxicity, disease progression, termination by the treating investigator, withdrawal of consent, termination of the program by the sponsor, or treatment delay greater than (>) 2 weeks for recovery of toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Dose Escalation: Treatment Phase |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| From Cycle 1 Day 1 up to 6 Cycles (Cycle length=28 days) of treatment, an average of 24 weeks |
| Disease Control Rate (DCR) | DCR was defined as the percentage of participants who had BOR of CR plus PR plus stable disease (SD). The best observed response (BOR) was defined as the best response recorded from the start of the study treatment until discontinuation from the study. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions. SD was defined as nonCR/non-progressive disease (PD) (NN), for participants with nontarget lesions. The minimum duration of SD was 7 weeks of multiple dose treatment. For participants who did not have target lesions, the response category NN was used instead of SD. DCR = CR + PR + SD greater than or equal to 7 weeks | From Cycle 1 Day 1 up to 6 Cycles (Cycle length=28 days) of treatment, an average of 24 weeks |
| Overall Survival (OS) | OS was defined as the time from the first dose of E7016 until 6 Cycles of treatment or death whichever occurs first. | From Cycle 1 Day 1 up to 6 Cycles (Cycle length=28 days) of treatment, an average of 24 weeks |
| Lebanon |
| New Hampshire |
| United States |
| Greenville | South Carolina | United States |
| San Antonio | Texas | United States |
| Charlottesville | Virginia | United States |
| FG001 | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | Participants received single oral dose of 8 mg/kg/day E7016 capsule on Day -7 for PK analysis, followed by once daily dose from days 1 to 5 in combination with temozolomide 150 mg/m^2 capsule and alone on days 6 and 7 of Cycle 1 (cycle length=28 days) in Treatment Phase. Participants who completed the Treatment Phase entered the Extension Phase of Dose Escalation Part and continued the treatment in Extension Phase in same manner of Treatment Phase until unacceptable toxicity, disease progression, termination by the treating investigator, withdrawal of consent, termination of the program by the sponsor, or treatment delay >2 weeks for recovery of toxicity. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Dose Escalation: Extension Phase |
|
|
The Safety Analysis Set (SAS) consisted of all participants who received at least one dose of E7016 or temozolomide and had at least one safety assessment after receiving these medications.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 | Participants received single oral dose of 4 mg/kg/day E7016 capsule on Day -7 for PK analysis, followed by once daily dose from days 1 to 5 in combination with temozolomide 150 mg/m^2 capsule and alone on days 6 and 7 of Cycle 1 (cycle length=28 days) in Treatment Phase. Participants who completed the Treatment Phase entered the Extension Phase of Dose Escalation Part and continued the treatment in Extension Phase in same manner of Treatment Phase until unacceptable toxicity, disease progression, termination by the treating investigator, withdrawal of consent, termination of the program by the sponsor, or treatment delay >2 weeks for recovery of toxicity. |
| BG001 | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | Participants received single oral dose of 8 mg/kg/day E7016 capsule on Day -7 for PK analysis, followed by once daily dose from days 1 to 5 in combination with temozolomide 150 mg/m^2 capsule and alone on days 6 and 7 of Cycle 1 (cycle length=28 days) in Treatment Phase. Participants who completed the Treatment Phase entered the Extension Phase of Dose Escalation Part and continued the treatment in Extension Phase in same manner of Treatment Phase until unacceptable toxicity, disease progression, termination by the treating investigator, withdrawal of consent, termination of the program by the sponsor, or treatment delay >2 weeks for recovery of toxicity. |
| BG002 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) for E7016 in Combination With Temozolomide | The MTD was defined as the highest dose of E7016 in combination with temozolomide at which no more than one of six participants experienced a dose-limiting toxicity (DLT). DLTs were defined as those adverse events (AEs) considered related to E7016 which occurred during the first cycle of study drug administration. DLTs were evaluated and graded based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version [v] 4.0). | The SAS consisted of all participants who received at least one dose of E7016 or temozolomide and had at least one safety assessment after receiving these medications. | Posted | Number | mg/kg/day | Cycle 1 (Cycle length = 28 days) |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Participants With Dose-limiting Toxicity (DLT) | A DLT was defined as those AEs considered related to E7016 which occurred during the first cycle of study drug administration. DLTs were evaluated and graded based on the NCI CTCAE version 4.0. The following toxicities were regarded as DLTs: a Grade 4 hematologic toxicity (lasting [greater than or equal to] >=5 days); a temozolomide dose reduction for Grade >=3 neutropenia or thrombocytopenia; or a Grade >=3 nonhematologic toxicity (except optimally managed nausea, vomiting, or diarrhea) that was assessed by the investigator as related to study drug. A participant with two or more DLTs with the same preferred term was counted only once for that preferred term. | The SAS consisted of all participants who received at least one dose of E7016 or temozolomide and had at least one safety assessment after receiving these medications. | Posted | Count of Participants | Participants | Cycle 1 (Cycle length = 28 days) |
| ||||||||||||||||||||||||||||
| Primary | Alternative Dose of Interest (ADI) for E7016 in Combination With Temozolomide | The ADI determination plan was based primarily on clinical, and/or PK measurements of drug concentration and/or bioactivity as defined by preclinical studies. However, the ADI was not pursued due to the limited sample size. | An ADI was not pursued due to the limited sample size. No data was collected and analyzed to report in this outcome measure. | Posted | Cycle 1 (Cycle length = 28 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | The ORR was defined as the percentage of participants with complete response (CR) plus partial response (PR) as determined by the investigator, using modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in the evaluation of magnetic resonance imaging/computerized tomography (MRI/CT) scans of targeted lesions and photographs and bone scans if appropriate for the tumor type. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions. ORR = CR + PR | The SAS consisted of all participants who received at least one dose of E7016 or temozolomide and had at least one safety assessment after receiving these medications. | Posted | Number | Percentage of participants | From Cycle 1 Day 1 up to 6 Cycles (Cycle length=28 days) of treatment, an average of 24 weeks |
| ||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | DCR was defined as the percentage of participants who had BOR of CR plus PR plus stable disease (SD). The best observed response (BOR) was defined as the best response recorded from the start of the study treatment until discontinuation from the study. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions. SD was defined as nonCR/non-progressive disease (PD) (NN), for participants with nontarget lesions. The minimum duration of SD was 7 weeks of multiple dose treatment. For participants who did not have target lesions, the response category NN was used instead of SD. DCR = CR + PR + SD greater than or equal to 7 weeks | The SAS consisted of all participants who received at least one dose of E7016 or temozolomide and had at least one safety assessment after receiving these medications. | Posted | Number | Percentage of participants | From Cycle 1 Day 1 up to 6 Cycles (Cycle length=28 days) of treatment, an average of 24 weeks |
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from the first dose of E7016 until 6 Cycles of treatment or death whichever occurs first. | The SAS consisted of all participants who received at least one dose of E7016 or temozolomide and had at least one safety assessment after receiving these medications. | Posted | Median | 95% Confidence Interval | days | From Cycle 1 Day 1 up to 6 Cycles (Cycle length=28 days) of treatment, an average of 24 weeks |
|
From date of first dose up to 30 days after the last dose of study drug (up to 45 weeks)
The SAS consisted of all participants who received at least one dose of E7016 or temozolomide and had at least one safety assessment after receiving these medications. As planned, combined safety data for Treatment phase and Extension phase was reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 | Participants received single oral dose of 4 mg/kg/day E7016 capsule on Day -7 for PK analysis, followed by once daily dose from days 1 to 5 in combination with temozolomide 150 mg/m^2 capsule and alone on days 6 and 7 of Cycle 1 (cycle length=28 days) in Treatment Phase. Participants who completed the Treatment Phase entered the Extension Phase of Dose Escalation Part and continued the treatment in Extension Phase in same manner of Treatment Phase until unacceptable toxicity, disease progression, termination by the treating investigator, withdrawal of consent, termination of the program by the sponsor, or treatment delay >2 weeks for recovery of toxicity. | 4 | 9 | 5 | 9 | 9 | 9 |
| EG001 | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | Participants received single oral dose of 8 mg/kg/day E7016 capsule on Day -7 for PK analysis, followed by once daily dose from days 1 to 5 in combination with temozolomide 150 mg/m^2 capsule and alone on days 6 and 7 of Cycle 1 (cycle length=28 days) in Treatment Phase. Participants who completed the Treatment Phase entered the Extension Phase of Dose Escalation Part and continued the treatment in Extension Phase in same manner of Treatment Phase until unacceptable toxicity, disease progression, termination by the treating investigator, withdrawal of consent, termination of the program by the sponsor, or treatment delay >2 weeks for recovery of toxicity. | 0 | 3 | 1 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ascites | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Hypovolemia | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Addominal tenderness | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA (13.1) | Systematic Assessment |
| |
| Weight 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 |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Paraethesia | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Restless leg syndrome | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Mental status change | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Dyspnoea external | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (13.1) | Systematic Assessment |
|
The study was terminated due to sponsor's strategic decision, which is unrelated to safety, therefore no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Information | Eisai Inc. | 1-888-274-2378 | esi_oncmedinfo@eisai.com |
| ID | Term |
|---|---|
| C559134 | 10-((4-hydroxypiperidin-1-yl)methyl)chromeno(4,3,2-de)phthalazin-3(2H)-one |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Other |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | Participants received single oral dose of 8 mg/kg/day E7016 capsule on Day -7 for PK analysis, followed by once daily dose from days 1 to 5 in combination with temozolomide 150 mg/m^2 capsule and alone on days 6 and 7 of Cycle 1 (cycle length=28 days) in Treatment Phase. Participants who completed the Treatment Phase entered the Extension Phase of Dose Escalation Part and continued the treatment in Extension Phase in same manner of Treatment Phase until unacceptable toxicity, disease progression, termination by the treating investigator, withdrawal of consent, termination of the program by the sponsor, or treatment delay >2 weeks for recovery of toxicity. |
|
|
|
| OG001 | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | Participants received single oral dose of 8 mg/kg/day E7016 capsule on Day -7 for PK analysis, followed by once daily dose from days 1 to 5 in combination with temozolomide 150 mg/m^2 capsule and alone on days 6 and 7 of Cycle 1 (cycle length=28 days) in Treatment Phase. Participants who completed the Treatment Phase entered the Extension Phase of Dose Escalation Part and continued the treatment in Extension Phase in same manner of Treatment Phase until unacceptable toxicity, disease progression, termination by the treating investigator, withdrawal of consent, termination of the program by the sponsor, or treatment delay >2 weeks for recovery of toxicity. |
|
|
| OG001 | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | Participants received single oral dose of 8 mg/kg/day E7016 capsule on Day -7 for PK analysis, followed by once daily dose from days 1 to 5 in combination with temozolomide 150 mg/m^2 capsule and alone on days 6 and 7 of Cycle 1 (cycle length=28 days) in Treatment Phase. Participants who completed the Treatment Phase entered the Extension Phase of Dose Escalation Part and continued the treatment in Extension Phase in same manner of Treatment Phase until unacceptable toxicity, disease progression, termination by the treating investigator, withdrawal of consent, termination of the program by the sponsor, or treatment delay >2 weeks for recovery of toxicity. |
|
|
|
|