Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT Number: 2009-010572-20 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Exelixis | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine safety, tolerability and maximum tolerated dose of BMS-863233 in subjects advanced and/or Metastatic solid tumors.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cdc7-inhibitor | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cdc7-inhibitor | Drug | Capsules, Oral, QD x 14 days until MTD is reached, 14d per 28 day cycle/QD 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) of BMS-863233 | DLT is defined based on adverse events that are deemed to be drug-related and occur during the first cycle of therapy using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. | Up to 28 days |
| Number of Participants With Adverse Events (AEs) | Number of participants with any grade adverse events (AEs), any grade drug-related AEs, any grade serious adverse events (SAEs), any grade drug-related SAEs, and any grade AEs leading to discontinuation of any drug. The severity of AEs will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | From first dose to 30 days post last dose (Up to 14 months) |
| Number of Participants Who Died | Number of participants who died due to any cause. | From first dose to 30 days post last dose (Up to 14 months) |
| Number of Participants With Lab Abnormalities Grade 3-4 | Number of participants with lab abnormalities grade 3-4 including hematology, chemistry, coagulation, liver and kidney function, and electrolytes using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade 3 = severe Grade 4 = very severe | From first dose to 30 days post last dose (Up to 14 months) |
| Measure | Description | Time Frame |
|---|---|---|
| BMS-863233 Maximum Observed Plasma Concentration (Cmax) | BMS-863233 maximum observed plasma concentration (Cmax) is derived from plasma concentration versus time data. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. | PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14 |
Not provided
Phase 1 Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute-Vendor | Boston | Massachusetts | 02115 | United States | ||
| Dana-Farber Cancer Institute |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BMS-863233 25 mg | BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator |
| FG001 | BMS-863233 50 mg | BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator |
| FG002 | BMS-863233 100 mg | BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BMS-863233 25 mg | BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator |
| BG001 | BMS-863233 50 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 | Number of Participants With Dose Limiting Toxicities (DLTs) of BMS-863233 | DLT is defined based on adverse events that are deemed to be drug-related and occur during the first cycle of therapy using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. | All treated participants | Posted | Count of Participants | Participants | Up to 28 days |
|
SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).
Not provided
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 | BMS-863233 25 mg | BMS-863233 25 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email | Clinical.Trials@bms.com |
Not provided
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BMS-863233 Time of Maximum Observed Plasma Concentration (Tmax) | BMS-863233 time of maximum observed plasma concentration (Tmax) is derived from plasma concentration versus time data. | PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14 |
| BMS-863233 Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU)) | BMS-863233 Area under the concentration-time curve in one dosing interval (AUC(TAU)) is derived from plasma concentration versus time data. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. | PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14 |
| BMS-863233 Clearance (CL) | BMS-863233 clearance (CL) is derived from plasma concentration versus time data. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. | PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14 |
| BMS-863233 Effective Elimination Half-Life (T-HALFeff) | Effective elimination half-life (T-HALFeff) is derived from plasma concentration versus time data. | PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-, 36-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14 |
| BMS-863233 Accumulation Index (AI_AUC) | BMS-863233 accumulation index (AI_AUC) is derived from plasma concentration versus time data. AI is calculated based on ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. | PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14 |
| BMS-863233 Trough Observed Plasma Concentration (Ctrough) | BMS-863233 trough observed plasma concentration (Ctrough) is derived from plasma concentration versus time data. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. | PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-, 24-hours end-of-infusion on Cycle 1 Day 2 (C1D2), (C1D7, or D8, or D9), and C1D14 |
| Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate | Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication. | Baseline and Predose, 2-, 4-, 8-, and 24-hours post dose on Cycle 1 Day 1 (C1D1), C3D1, C4D1, C1D2, C1D15, C3D15, |
| Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval | Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication. | Baseline and Predose, 2-, 4-, 8-, and 24-hours post dose on Cycle 1 Day 1 (C1D1), C1D14, C3D1, C3D15, C4D1 |
| Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Interval | Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication. | Baseline and Predose, 2-, 4-, 8-, and 24-hours post dose on Cycle 1 Day 1 (C1D1), C1D14, C3D1, C3D15, C4D1 |
| Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval | Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication. | Baseline and Predose, 2-, 4-, 8-, and 24-hours post dose on Cycle 1 Day 1 (C1D1), C1D14, C3D1, C3D15, C4D1 |
| Objective Response Rate (ORR) | ORR is defined as the total percentage of participants whose best response is either a complete response (CR) or a partial response (PR) defined by the RECIST criteria. CR= Complete disappearance of all tumor lesions. PR= Decrease, relative to baseline, of 30% or greater in the sum of the longest diameter of all "target" lesions. | From first dose up to 14 months |
| Disease Control Rate (DCR) | DCR is defined as the total percentage of participants whose best response is complete response (CR), partial response (PR), or ≥ 4 months stable disease (SD) defined by the RECIST criteria. CR= Complete disappearance of all tumor lesions. PR= Decrease, relative to baseline, of 30% or greater in the sum of the longest diameter of all "target" lesions. SD= Failure to meet criteria for complete or partial response, in the absence of progressive disease. | From first dose up to 14 months |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Local Institution - 003 | Toronto | Ontario | M5G 2M9 | Canada |
| Local Institution | Toronto | Ontario | M5G 2M9 | Canada |
| Local Institution | Villejuif | 94800 | France |
| Adverse event unrelated to Study drug |
|
BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator |
| BG002 | BMS-863233 100 mg | BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator |
| 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 |
|
BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator |
| OG002 | BMS-863233 100 mg | BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator |
|
|
| Primary | Number of Participants With Adverse Events (AEs) | Number of participants with any grade adverse events (AEs), any grade drug-related AEs, any grade serious adverse events (SAEs), any grade drug-related SAEs, and any grade AEs leading to discontinuation of any drug. The severity of AEs will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | All treated participants | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (Up to 14 months) |
|
|
|
| Primary | Number of Participants Who Died | Number of participants who died due to any cause. | All treated participants | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (Up to 14 months) |
|
|
|
| Primary | Number of Participants With Lab Abnormalities Grade 3-4 | Number of participants with lab abnormalities grade 3-4 including hematology, chemistry, coagulation, liver and kidney function, and electrolytes using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade 3 = severe Grade 4 = very severe | All treated participants | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (Up to 14 months) |
|
|
|
| Secondary | BMS-863233 Maximum Observed Plasma Concentration (Cmax) | BMS-863233 maximum observed plasma concentration (Cmax) is derived from plasma concentration versus time data. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. | All participants who received at least one dose of BMS-863233 and have evaluable plasma concentration data | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14 |
|
|
|
| Secondary | BMS-863233 Time of Maximum Observed Plasma Concentration (Tmax) | BMS-863233 time of maximum observed plasma concentration (Tmax) is derived from plasma concentration versus time data. | All participants who received at least one dose of BMS-863233 and have evaluable plasma concentration data | Posted | Median | Full Range | Hours | PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14 |
|
|
|
| Secondary | BMS-863233 Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU)) | BMS-863233 Area under the concentration-time curve in one dosing interval (AUC(TAU)) is derived from plasma concentration versus time data. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. | All participants who received at least one dose of BMS-863233 and have evaluable plasma concentration data | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14 |
|
|
|
| Secondary | BMS-863233 Clearance (CL) | BMS-863233 clearance (CL) is derived from plasma concentration versus time data. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. | All participants who received at least one dose of BMS-863233 and have evaluable plasma concentration data | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/min | PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14 |
|
|
|
| Secondary | BMS-863233 Effective Elimination Half-Life (T-HALFeff) | Effective elimination half-life (T-HALFeff) is derived from plasma concentration versus time data. | All participants who received at least one dose of BMS-863233 and have evaluable plasma concentration data | Posted | Median | Full Range | Hours | PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-, 36-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14 |
|
|
|
| Secondary | BMS-863233 Accumulation Index (AI_AUC) | BMS-863233 accumulation index (AI_AUC) is derived from plasma concentration versus time data. AI is calculated based on ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. | All participants who received at least one dose of BMS-863233 and have evaluable plasma concentration data | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14 |
|
|
|
| Secondary | BMS-863233 Trough Observed Plasma Concentration (Ctrough) | BMS-863233 trough observed plasma concentration (Ctrough) is derived from plasma concentration versus time data. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. | All participants who received at least one dose of BMS-863233 and have evaluable plasma concentration data | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-, 24-hours end-of-infusion on Cycle 1 Day 2 (C1D2), (C1D7, or D8, or D9), and C1D14 |
|
|
|
| Secondary | Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate | Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication. | All treated participants with baseline measurements | Posted | Mean | Standard Deviation | Beats/min | Baseline and Predose, 2-, 4-, 8-, and 24-hours post dose on Cycle 1 Day 1 (C1D1), C3D1, C4D1, C1D2, C1D15, C3D15, |
|
|
|
| Secondary | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval | Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication. | All treated participants with baseline measurements | Posted | Mean | Standard Deviation | msec | Baseline and Predose, 2-, 4-, 8-, and 24-hours post dose on Cycle 1 Day 1 (C1D1), C1D14, C3D1, C3D15, C4D1 |
|
|
|
| Secondary | Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Interval | Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication. | All treated participants with baseline measurements | Posted | Mean | Standard Deviation | msec | Baseline and Predose, 2-, 4-, 8-, and 24-hours post dose on Cycle 1 Day 1 (C1D1), C1D14, C3D1, C3D15, C4D1 |
|
|
|
| Secondary | Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval | Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication. | All treated participants with baseline measurements | Posted | Mean | Standard Deviation | msec | Baseline and Predose, 2-, 4-, 8-, and 24-hours post dose on Cycle 1 Day 1 (C1D1), C1D14, C3D1, C3D15, C4D1 |
|
|
|
| Secondary | Objective Response Rate (ORR) | ORR is defined as the total percentage of participants whose best response is either a complete response (CR) or a partial response (PR) defined by the RECIST criteria. CR= Complete disappearance of all tumor lesions. PR= Decrease, relative to baseline, of 30% or greater in the sum of the longest diameter of all "target" lesions. | All treated participants | Posted | Number | 95% Confidence Interval | Perentage of participants | From first dose up to 14 months |
|
|
|
| Secondary | Disease Control Rate (DCR) | DCR is defined as the total percentage of participants whose best response is complete response (CR), partial response (PR), or ≥ 4 months stable disease (SD) defined by the RECIST criteria. CR= Complete disappearance of all tumor lesions. PR= Decrease, relative to baseline, of 30% or greater in the sum of the longest diameter of all "target" lesions. SD= Failure to meet criteria for complete or partial response, in the absence of progressive disease. | All treated participants | Posted | Number | 95% Confidence Interval | Perentage of participants | From first dose up to 14 months |
|
|
|
| 0 |
| 3 |
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | BMS-863233 50 mg | BMS-863233 50 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator | 1 | 3 | 1 | 3 | 2 | 3 |
| EG002 | BMS-863233 100 mg | BMS-863233 100 mg orally once daily on Days 1 to 14 of a 28-day cycle (2 weeks on treatment, 2 weeks off treatment) until progression of disease, unacceptable toxicity, withdrawal of the participant's consent, or at the discretion of the Investigator | 2 | 5 | 4 | 5 | 5 | 5 |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| LOCALISED OEDEMA | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
|
| BACTERAEMIA | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| MALIGNANT NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| SPINAL CORD COMPRESSION | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| VISION BLURRED | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| ABDOMINAL TENDERNESS | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| FAECAL INCONTINENCE | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| PROCTALGIA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| RHINITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| BLOOD CREATININE | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| BLOOD LACTATE DEHYDROGENASE INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| CAUDA EQUINA SYNDROME | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| CEREBRAL ISCHAEMIA | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| SPINAL CORD COMPRESSION | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
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| DYSURIA | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
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| POLLAKIURIA | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
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| PROTEINURIA | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
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| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| PULMONARY CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| WHEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| GENERALISED ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| FLUSHING | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
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Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Measurements |
|---|---|
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| SAEs |
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| Drug-related SAEs |
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| AEs leading to discontinuation |
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| Hematology: Lymphocytes, low |
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| Coagulation |
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| Liver and Kidney Function |
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| Electrolytes: Hyponatremia, low |
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| Electrolytes: Phosphorus, low |
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| Other Chemistry Testing |
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| Day 14 |
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| Day 14 |
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| Day 14 |
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| C1D7, or D8, or D9 predose |
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| C1D14 predose |
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| C1D14 24hr postdose |
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| 4 hours post dose C1D1 |
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| 8 hours post dose C1D1 |
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| 24 hours post dose C1D2 |
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| Predose C1D15 |
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| 2 hours post dose C1D15 |
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| 4 hours post dose C1D15 |
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| 8 hours post dose C1D15 |
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| 24 hours post dose C1D15 |
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| 2 hours post dose C3D1 |
|
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| 4 hours post dose C3D1 |
|
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| 8 hours post dose C3D1 |
|
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| 24 hours post dose C3D1 |
|
|
| Predose C3D15 |
|
|
| 2 hours post dose C3D15 |
|
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| 4 hours post dose C3D15 |
|
|
| 8 hours post dose C3D15 |
|
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| 24 hours post dose C3D15 |
|
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| 24 hours post dose C4D1 |
|
|
| 4 hours post dose C1D1 |
|
|
| 8 hours post dose C1D1 |
|
|
| 24 hours post dose C1D2 |
|
|
| Predose C1D15 |
|
|
| 2 hours post dose C1D15 |
|
|
| 4 hours post dose C1D15 |
|
|
| 8 hours post dose C1D15 |
|
|
| 24 hours post dose C1D15 |
|
|
| 2 hours post dose C3D1 |
|
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| 4 hours post dose C3D1 |
|
|
| 8 hours post dose C3D1 |
|
|
| 24 hours post dose C3D1 |
|
|
| Predose C3D15 |
|
|
| 2 hours post dose C3D15 |
|
|
| 4 hours post dose C3D15 |
|
|
| 8 hours post dose C3D15 |
|
|
| 24 hours post dose C3D15 |
|
|
| 24 hours post dose C4D1 |
|
|
| 4 hours post dose C1D1 |
|
|
| 8 hours post dose C1D1 |
|
|
| 24 hours post dose C1D2 |
|
|
| Predose C1D15 |
|
|
| 2 hours post dose C1D15 |
|
|
| 4 hours post dose C1D15 |
|
|
| 8 hours post dose C1D15 |
|
|
| 24 hours post dose C1D15 |
|
|
| 2 hours post dose C3D1 |
|
|
| 4 hours post dose C3D1 |
|
|
| 8 hours post dose C3D1 |
|
|
| 24 hours post dose C3D1 |
|
|
| Predose C3D15 |
|
|
| 2 hours post dose C3D15 |
|
|
| 4 hours post dose C3D15 |
|
|
| 8 hours post dose C3D15 |
|
|
| 24 hours post dose C3D15 |
|
|
| 24 hours post dose C4D1 |
|
|
| 4 hours post dose C1D1 |
|
|
| 8 hours post dose C1D1 |
|
|
| 24 hours post dose C1D2 |
|
|
| Predose C1D15 |
|
|
| 2 hours post dose C1D15 |
|
|
| 4 hours post dose C1D15 |
|
|
| 8 hours post dose C1D15 |
|
|
| 24 hours post dose C1D15 |
|
|
| 2 hours post dose C3D1 |
|
|
| 4 hours post dose C3D1 |
|
|
| 8 hours post dose C3D1 |
|
|
| 24 hours post dose C3D1 |
|
|
| Predose C3D15 |
|
|
| 2 hours post dose C3D15 |
|
|
| 4 hours post dose C3D15 |
|
|
| 8 hours post dose C3D15 |
|
|
| 24 hours post dose C3D15 |
|
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| 24 hours post dose C4D1 |
|
|