Breast Cancer
Conditions
Brief summary
The purpose of this study is to evaluate oral doses of BMS-754807 in combination with letrozole or BMS-754807 alone are safe and efficacious in locally advanced or metastatic hormone receptor positive breast cancer subjects who have progressed with prior non-steroidal aromatase inhibitor treatment.
Interventions
DRUGBMS-754807
Tablet, Oral, 100 mg, Daily, Until disease progression or unacceptable toxicity
DRUGletrozole
Tablets, Oral, 2.5 mg, Daily, Until disease progression or unacceptable toxicity
Sponsors
Mayo Clinic
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Postmenopausal women with hormone receptor-positive and HER-2 negative breast cancer * Disease progression following non-steroidal aromatase inhibitor treatment
Exclusion criteria
* Known symptomatic brain metastasis * Medical condition requiring chronic steroids * History of Type 1 or 2 Diabetes * Uncontrolled or significant cardiovascular (CV) disease * Concomitant second malignancies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival Rate at 24 Weeks | 24 weeks after initiation of study treatment | Progression free survival (PFS) rate at 24 weeks after treatment with BMS 754807/letrozole was to be calculated as the total number of subjects neither progressed nor died after 24 weeks of treatment divided by the total number of subjects (with measurable or non-measurable disease) randomized/assigned to combination treatment arm and treated. In participants with measurable disease Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) criteria was to be used to assess disease progression.This outcome was not measured due to early termination of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious AEs, Non-serious AEs , Discontinuation Due to AEs and Deaths | Non-SAEs: Day 1 to 7 days after the participant discontinues study medication or 7 days after the End of Treatment visit (up to 42 months), For SAEs: during the screening period and within 30 days of discontinuation of dosing ,up to 42 months | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. |
| Duration of Response (DOR) in Participants With Measurable Disease | 24 weeks after initiation of study treatment | DOR was to be performed to further characterize the response rate at Week 24. Duration of response is defined as the time between the Week 25 date of response and the date of objectively documented disease progression as defined by modified RECIST 1.1 criteria or death, whichever occurs first. DOR could not be assessed due to early termination of the study. |
| Number of On-study Laboratory Abnormalities: Grade 1-2 | Assessed from day 1 up to within 30 days of last dose (Approximately 42 months) | Blood and urine samples were obtained at specified times points for laboratory evaluations. Clinical Laboratory Sage Panels included: Hematology: Hemoglobin, Hematocrit, Red blood cell, Total leukocyte count, including differential, Platelet count. Serum Chemistry : Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALK-P), Bilirubin, total (TB). Reflex testing of direct (conjugated) and indirect (unconjugated) bilirubin will be ordered if total bilirubin \> 5X ULN, Blood urea nitrogen (BUN or urea), Calcium, Chloride, Cholesterol, Creatinine, serum, Glucose, fasting plasma, Lactate dehydrogenase (LDH), Magnesium, Phosphorus, Potassium, Protein, total, Sodium, Triglycerides, Uric acid Urinalysis, Blood, Glucose, Ketones, Leukocyte esterase, pH, Protein. Laboratory tests were graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0 criteria |
| The Objective Response Rate (ORR) in Participants With Measurable Disease | 24 weeks after initiation of study treatment | ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment. Participants were to be evaluated for tumor response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions.: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. This outcome measure was not met due to early termination of the study |
| Treatment Failure Rate (TFR) | 24 weeks after initiation of study treatment | The TFR was to be calculated as the total number of subjects who discontinued the treatment for any reason (including disease progression, treatment toxicity, and death) at 24 weeks divided by the total number of subjects randomized/assigned to the arm and treated. In the monotherapy arm, the TFR was to be assessed while subjects were on monotherapy. |
| Changes in Absolute Copy Numbers and Relative Expression of Insulin Receptor Isoform A (IR-A) in Tumor Tissue in Response to Treatment | 24 weeks after initiation of study | Absolute copy numbers and relative expression of insulin receptor isoforms (IR-A, IR-B) in pre- and posttreatment fresh tumor tissues were to be measured. This outcome was not measured due to early termination of the study. |
| Number of On-study Laboratory Abnormalities: Grade 3-4 | Assessed from day 1 up to within 30 days of last dose (Approximately 42 months) | Blood and urine samples were obtained at specified times points for laboratory evaluations. Clinical Laboratory Sage Panels included: Hematology: Hemoglobin, Hematocrit, Red blood cell, Total leukocyte count, including differential, Platelet count. Serum Chemistry : Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALK-P), Bilirubin, total (TB). Reflex testing of direct (conjugated) and indirect (unconjugated) bilirubin will be ordered if total bilirubin \> 5X ULN, Blood urea nitrogen (BUN or urea), Calcium, Chloride, Cholesterol, Creatinine, serum, Glucose, fasting plasma, Lactate dehydrogenase (LDH), Magnesium, Phosphorus, Potassium, Protein, total, Sodium, Triglycerides, Uric acid Urinalysis, Blood, Glucose, Ketones, Leukocyte esterase, pH, Protein Laboratory tests were graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0 criteria |
Countries
United States
Participant flow
Pre-assignment details
77 participants were enrolled, 59 of whom were treated. Reasons for not entering treatment period included: 3 participants withdrew consent; 11 participants no longer met study criteria and 4 were due to other reasons.
Participants by arm
| Arm | Count |
|---|---|
| BMS 100+LET Treatment with 100 mg BMS-754807 + 2.5 mg letrozole | 52 |
| BMS 100 100 mg BMS-754807 alone | 7 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Subject decision to stop | 1 | 0 |
| Overall Study | Subject no longer meets study criteria | 1 | 0 |
| Overall Study | Subject request to discontinue treatment | 3 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | BMS 100+LET | BMS 100 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 3 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 4 Participants | 39 Participants |
| Age, Continuous | 60.0 Years STANDARD_DEVIATION 12.21 | 64.4 Years STANDARD_DEVIATION 8.58 | 60.5 Years STANDARD_DEVIATION 11.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 6 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 46 Participants | 6 Participants | 52 Participants |
| Sex: Female, Male Female | 52 Participants | 7 Participants | 59 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 52 | 0 / 7 |
| other Total, other adverse events | 51 / 52 | 7 / 7 |
| serious Total, serious adverse events | 11 / 52 | 1 / 7 |
Outcome results
Primary
Progression Free Survival Rate at 24 Weeks
Progression free survival (PFS) rate at 24 weeks after treatment with BMS 754807/letrozole was to be calculated as the total number of subjects neither progressed nor died after 24 weeks of treatment divided by the total number of subjects (with measurable or non-measurable disease) randomized/assigned to combination treatment arm and treated. In participants with measurable disease Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) criteria was to be used to assess disease progression.This outcome was not measured due to early termination of the study.
Time frame: 24 weeks after initiation of study treatment
Population: PFS data was not collected for any participants because the study was terminated
Secondary
Changes in Absolute Copy Numbers and Relative Expression of Insulin Receptor Isoform A (IR-A) in Tumor Tissue in Response to Treatment
Absolute copy numbers and relative expression of insulin receptor isoforms (IR-A, IR-B) in pre- and posttreatment fresh tumor tissues were to be measured. This outcome was not measured due to early termination of the study.
Time frame: 24 weeks after initiation of study
Population: Data for this Outcome Measure was not collected for any participants because the study was terminated
Secondary
Duration of Response (DOR) in Participants With Measurable Disease
DOR was to be performed to further characterize the response rate at Week 24. Duration of response is defined as the time between the Week 25 date of response and the date of objectively documented disease progression as defined by modified RECIST 1.1 criteria or death, whichever occurs first. DOR could not be assessed due to early termination of the study.
Time frame: 24 weeks after initiation of study treatment
Population: DOR data was not collected for any participants because the study was terminated early
Secondary
Number of On-study Laboratory Abnormalities: Grade 1-2
Blood and urine samples were obtained at specified times points for laboratory evaluations. Clinical Laboratory Sage Panels included: Hematology: Hemoglobin, Hematocrit, Red blood cell, Total leukocyte count, including differential, Platelet count. Serum Chemistry : Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALK-P), Bilirubin, total (TB). Reflex testing of direct (conjugated) and indirect (unconjugated) bilirubin will be ordered if total bilirubin \> 5X ULN, Blood urea nitrogen (BUN or urea), Calcium, Chloride, Cholesterol, Creatinine, serum, Glucose, fasting plasma, Lactate dehydrogenase (LDH), Magnesium, Phosphorus, Potassium, Protein, total, Sodium, Triglycerides, Uric acid Urinalysis, Blood, Glucose, Ketones, Leukocyte esterase, pH, Protein. Laboratory tests were graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0 criteria
Time frame: Assessed from day 1 up to within 30 days of last dose (Approximately 42 months)
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 1-2 | Creatinine | 11 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 1-2 | Neutrophils (absolute) | 15 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 1-2 | Aspartate Aminotransferase (AST) | 17 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 1-2 | Glucose, fasting plasma | 21 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 1-2 | Absolute Neutrophil Count | 16 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 1-2 | Phosphorus, inorganic | 5 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 1-2 | Alanine Aminotransferase (ALT) | 7 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 1-2 | Platelet count | 14 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 1-2 | Hemoglobin | 27 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 1-2 | Bilirubin, total | 3 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 1-2 | Cholesterol, Total (TC) | 28 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 1-2 | Triglycerides | 1 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 1-2 | Lymphocytes (absolute) | 32 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 1-2 | Triglycerides, fasting | 15 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 1-2 | Alkaline Phosphatase (ALP) | 12 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 1-2 | Uric acid | 10 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 1-2 | Magnesium , serum | 13 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 1-2 | Leukocytes | 17 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 1-2 | Albumin | 13 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 1-2 | Leukocytes | 3 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 1-2 | Albumin | 0 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 1-2 | Alkaline Phosphatase (ALP) | 2 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 1-2 | Alanine Aminotransferase (ALT) | 1 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 1-2 | Aspartate Aminotransferase (AST) | 1 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 1-2 | Cholesterol, Total (TC) | 4 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 1-2 | Creatinine | 0 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 1-2 | Absolute Neutrophil Count | 3 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 1-2 | Hemoglobin | 1 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 1-2 | Lymphocytes (absolute) | 4 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 1-2 | Magnesium , serum | 1 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 1-2 | Neutrophils (absolute) | 2 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 1-2 | Glucose, fasting plasma | 3 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 1-2 | Phosphorus, inorganic | 0 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 1-2 | Platelet count | 1 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 1-2 | Bilirubin, total | 1 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 1-2 | Triglycerides | 0 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 1-2 | Triglycerides, fasting | 2 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 1-2 | Uric acid | 1 Number of abnormalities |
Secondary
Number of On-study Laboratory Abnormalities: Grade 3-4
Blood and urine samples were obtained at specified times points for laboratory evaluations. Clinical Laboratory Sage Panels included: Hematology: Hemoglobin, Hematocrit, Red blood cell, Total leukocyte count, including differential, Platelet count. Serum Chemistry : Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALK-P), Bilirubin, total (TB). Reflex testing of direct (conjugated) and indirect (unconjugated) bilirubin will be ordered if total bilirubin \> 5X ULN, Blood urea nitrogen (BUN or urea), Calcium, Chloride, Cholesterol, Creatinine, serum, Glucose, fasting plasma, Lactate dehydrogenase (LDH), Magnesium, Phosphorus, Potassium, Protein, total, Sodium, Triglycerides, Uric acid Urinalysis, Blood, Glucose, Ketones, Leukocyte esterase, pH, Protein Laboratory tests were graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0 criteria
Time frame: Assessed from day 1 up to within 30 days of last dose (Approximately 42 months)
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 3-4 | Creatinine | 0 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 3-4 | Neutrophils (absolute) | 0 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 3-4 | Aspartate Aminotransferase (AST) | 1 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 3-4 | Glucose, fasting plasma | 6 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 3-4 | Absolute Neutrophil Count | 0 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 3-4 | Phosphorus, inorganic | 0 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 3-4 | Alanine Aminotransferase (ALT) | 1 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 3-4 | Platelet count | 2 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 3-4 | Hemoglobin | 0 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 3-4 | Bilirubin, total | 0 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 3-4 | Cholesterol, Total (TC) | 0 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 3-4 | Triglycerides | 0 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 3-4 | Lymphocytes (absolute) | 4 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 3-4 | Triglycerides, fasting | 0 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 3-4 | Alkaline Phosphatase (ALP) | 2 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 3-4 | Uric acid | 3 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 3-4 | Magnesium , serum | 0 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 3-4 | Leukocytes | 0 Number of abnormalities |
| BMS 100 + LET | Number of On-study Laboratory Abnormalities: Grade 3-4 | Albumin | 0 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 3-4 | Leukocytes | 0 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 3-4 | Albumin | 0 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 3-4 | Alkaline Phosphatase (ALP) | 0 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 3-4 | Alanine Aminotransferase (ALT) | 0 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 3-4 | Aspartate Aminotransferase (AST) | 0 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 3-4 | Cholesterol, Total (TC) | 0 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 3-4 | Creatinine | 0 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 3-4 | Absolute Neutrophil Count | 0 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 3-4 | Hemoglobin | 0 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 3-4 | Lymphocytes (absolute) | 0 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 3-4 | Magnesium , serum | 0 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 3-4 | Neutrophils (absolute) | 0 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 3-4 | Glucose, fasting plasma | 1 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 3-4 | Phosphorus, inorganic | 0 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 3-4 | Platelet count | 0 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 3-4 | Bilirubin, total | 0 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 3-4 | Triglycerides | 0 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 3-4 | Triglycerides, fasting | 0 Number of abnormalities |
| BMS 100 | Number of On-study Laboratory Abnormalities: Grade 3-4 | Uric acid | 0 Number of abnormalities |
Secondary
Number of Participants With Adverse Events (AEs), Serious AEs, Non-serious AEs , Discontinuation Due to AEs and Deaths
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.
Time frame: Non-SAEs: Day 1 to 7 days after the participant discontinues study medication or 7 days after the End of Treatment visit (up to 42 months), For SAEs: during the screening period and within 30 days of discontinuation of dosing ,up to 42 months
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BMS 100 + LET | Number of Participants With Adverse Events (AEs), Serious AEs, Non-serious AEs , Discontinuation Due to AEs and Deaths | No. of participants with Serious AEs | 11 Participants |
| BMS 100 + LET | Number of Participants With Adverse Events (AEs), Serious AEs, Non-serious AEs , Discontinuation Due to AEs and Deaths | No. of discontinuations due to AEs | 11 Participants |
| BMS 100 + LET | Number of Participants With Adverse Events (AEs), Serious AEs, Non-serious AEs , Discontinuation Due to AEs and Deaths | No. of deaths | 5 Participants |
| BMS 100 + LET | Number of Participants With Adverse Events (AEs), Serious AEs, Non-serious AEs , Discontinuation Due to AEs and Deaths | No. of participants with non-serious AEs | 51 Participants |
| BMS 100 + LET | Number of Participants With Adverse Events (AEs), Serious AEs, Non-serious AEs , Discontinuation Due to AEs and Deaths | No. of participants with AEs (All grades) | 51 Participants |
| BMS 100 | Number of Participants With Adverse Events (AEs), Serious AEs, Non-serious AEs , Discontinuation Due to AEs and Deaths | No. of participants with non-serious AEs | 7 Participants |
| BMS 100 | Number of Participants With Adverse Events (AEs), Serious AEs, Non-serious AEs , Discontinuation Due to AEs and Deaths | No. of participants with Serious AEs | 1 Participants |
| BMS 100 | Number of Participants With Adverse Events (AEs), Serious AEs, Non-serious AEs , Discontinuation Due to AEs and Deaths | No. of participants with AEs (All grades) | 7 Participants |
| BMS 100 | Number of Participants With Adverse Events (AEs), Serious AEs, Non-serious AEs , Discontinuation Due to AEs and Deaths | No. of discontinuations due to AEs | 2 Participants |
| BMS 100 | Number of Participants With Adverse Events (AEs), Serious AEs, Non-serious AEs , Discontinuation Due to AEs and Deaths | No. of deaths | 0 Participants |
Secondary
The Objective Response Rate (ORR) in Participants With Measurable Disease
ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment. Participants were to be evaluated for tumor response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions.: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. This outcome measure was not met due to early termination of the study
Time frame: 24 weeks after initiation of study treatment
Population: ORR data was not collected for any participants because the study was terminated
Secondary
Treatment Failure Rate (TFR)
The TFR was to be calculated as the total number of subjects who discontinued the treatment for any reason (including disease progression, treatment toxicity, and death) at 24 weeks divided by the total number of subjects randomized/assigned to the arm and treated. In the monotherapy arm, the TFR was to be assessed while subjects were on monotherapy.
Time frame: 24 weeks after initiation of study treatment
Population: TFR data was not collected for any participants because the study was terminated