Bristol-Myers Squibb: U.S. Commitment Studies
 
U.S. Commitment Studies
Compound
Name
Description of
Commitment
Date Commitment Given FDA Projected Completion Date Study Status Notes
ABATACEPT Continue the open label extensions of 5 studies (IM101-100, IM101-101, IM101-102, IM101-029, IM101-031) to obtain data and perform appropriate safety analyses for 5-years' exposure to Abatacept for 1000-1500 patients. 23-Dec-05 30-Jun-10 Submitted
ABATACEPT Protocol IM101045A, a pharmacoepidemiology study to assess the short term (2 years) and potential long term (4 years) risk of hospitalization due to infection (all hospitalized infections, hospitalized pneumonia, and all opportunistic infections) among patients with RA treated with Abatacept in comparison to other DMARDs within a large cohort of individuals with commercial health insurance. This study will also characterize patients receiving Abatacept and monitor any off-label use. 23-Dec-05 31-Dec-16 Ongoing
ABATACEPT Protocol IM101045B, proposed as an observational prospective pharmacoepidemiology cohort study to assess the short and long-term risk of malignancies and infection in patients with RA treated with Abatacept in comparison to other DMARDs within an existing registry containing patients with rheumatoid arthritis. Follow-up will be for at least 5 years after the last patient is enrolled. 23-Dec-05 31-Dec-16 Ongoing
ABATACEPT Submission of the protocol, interim reports, and final study report for a JIA patient safety registry comprised of at least 500 patients. This protocol should include a plan for more intensive scrutiny for the first 3 years, with annual follow ups (which could be telephonic) assessing for occurrence of malignancies, other autoimmune diseases, and serious infections, for a total of 10 years. Patients turning 18 years of age or older should continue to be followed until they have completed the 10 year follow-up period. Information on these patients may be obtained via annual questionnaire/ telephonic follow-up with attention to key adverse events rather than full clinic visit with examination. Protocol Submission: December 31, 2008; Study Start: June 30, 2009; Interim Report Submissions: June 30, 2014/2019/2024; Final Report Submission: June 30, 2029 7-Apr-08 30-Jun-29 Delayed Info
ABATACEPT Conduct a PK/safety study of SC abatacept in polyaricular JIA patients ages 6 to 17 years of age. 29-Jul-11 31-Jan-18 Ongoing
ATAZANAVIR SULPHATE Deferred pediatric study or studies under PREA for the treatment of HIV-1 infection in pediatric patients ages ≥3 months to 18 years to obtain a minimum of 100 patients followed for safety for a minimum of 24 weeks at the recommended dose or any higher doses studied during pediatric development. Final Report Submission: December 15, 2010. 25-Mar-08 31-Mar-15 Ongoing
BELATACEPT PMR 1: Conduct a prospective, observational study utilizing data from the United Network for Organ Sharing (UNOS) on the pattern of belatacept use in US adult kidney-only transplant recipients at transplant and one year post-transplant. Specifically, the study will assess the prevalence of belatacept use and the characteristics of belatacept users, as related to the risk of PTLD, including Epstein-Barr Virus (EBV) and cytomegalovirus (CMV) serostatus. In addition, the study will collect information on adult kidney-only transplant recipients who switch to or from belatacept within one year post-transplant. (Protocol Number IM103074). 15-Jun-11 30-Apr-20 Ongoing
BELATACEPT PMR 2: Conduct a prospective observational study utilizing data from the United Network for Organ Sharing (UNOS) on the incidence rates of post-transplant lymphoproliferative disorder (PTLD) in US adult kidney-only transplant recipients who are treated with belatacept compared to recipients treated with calcineurin inhibitor (CNI)-based regimens. Recipient characteristics will be collected, including EBV and CMV serostatus, location of the PTLD, and outcome (survival or mortality). Incidence rates of PTLD in belatacept-exposed patients will be quantified beginning when 500 belatacept-exposed patients have at least 1 year of follow-up. Relative risks of PTLD for belatacept compared to CNI-based regimens will be estimated after 1,000 person years have been accumulated in transplant recipients initiated on belatacept at transplantation. (Protocol Number IM103075). 15-Jun-11 30-Apr-20 Ongoing
BELATACEPT PMR 3: Conduct a prospective registry of belatacept use in US adult kidney-only transplant recipients to determine the incidence rates of post-transplant lymphoproliferative disorder PTLD, PTLD in the central nervous system (CNS PTLD), and progressive multifocal leukoencephalopathy (PML) in US adult EBV seropositve kidney transplant recipients treated with belatacept in clinical practice. All US adult kidney transplant centers dispensing belatacept will be asked to participate in the study (i.e., if a center does not respond or declines to participate, the reason(s) for nonparticipation will be identified and documented). Recipient characteristics will be collected, including EBV and CMV serostatus, timing of initiation of belatacept in relation to the transplant, location of the PTLD, and outcome (survival or mortality). (Protocol Number IM13076). 15-Jun-11 30-Apr-20 Ongoing
DASATINIB 1699-1 To submit the final report (at least 60 months of follow-up) and data from CA180056 entitled "An Open-Label, Randomized, Multicenter Phase III Trial of Dasatinib versus Standard Dose Imatinib in the Treatment of Subjects with Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia." 28-Oct-10 30-Nov-14 Ongoing
EFAVIRENZ Perform a label comparison study to determine whether patients and/or caregivers can understand and follow the instructions for use of Sustiva (efavirenz) capsule sprinkles. The protocol for this study should be provided to the Division of Antiviral Products for review and comment prior to study initiation. 2-May-13 31-May-14 Pending
ENTECAVIR FDA PMC #1: Deferred pediatric study/substudy under PREA for the treatment of chronic hepatitis B with evidence of active liver inflammation in pediatric subjects ages from birth to 16 years of age. This study will determine the entecavir exposure (pharmacokinetics profile) for pediatric subjects ages from birth through 16 years of age to support dose-selection for the efficacy and safety assessment. 29-Mar-05 30-Nov-13 Submitted
ENTECAVIR FDA PMC #2: Deferred pediatric study under PREA for the treatment of chronic hepatitis B with evidence of active liver inflammation in pediatric subjects ages from birth to 16 years of age. Using doses selected based on study/substudy in postmarketing commitment 1, conduct a pediatric safety and efficacy study of entecavir with efficacy based on the results of a variety of virologic, biochemical, serologic, and composite endpoints over at least 48 weeks of dosing and safety monitored over 48 weeks. 29-Mar-05
31-Dec-18 Ongoing
ENTECAVIR FDA PMC #10: Conduct and submit a final study report for a study to evaluate the safety, efficacy, and resistance profile of Entecavir used in combination with another oral anti-BV therapy in treatment-naive and treatment-experienced patients with chronic HBV to determine if there is any added benefit of combination therapy. 29-Mar-05 31-Dec-09 Submitted
ENTECAVIR FDA PMC #8: Complete and submit the final study reports for Studies 901 and 049 to obtain long-term dosing (> five-years for some subjects) and follow-up data (> five-years for some subjects) on Entecavir use in subjects rolled-over from the Phase-2 and Phase-3 clinical trials to address the following issues: * maintenance of virologic suppression; * durability of HBeAg seroconversion and the rate of new events; * risk of drug-related adverse events including malignancy; and * risk for development of resistance to entecavir. 29-Mar-05 31-Jul-11 Submitted
ENTECAVIR FDA PMC #3: Conduct and submit a final study report for a large simple safety study to assess the major clinical outcomes of death, progression of liver disease, and cancer in a broad population of HBV-infected patients using entecavir compared to standard of care over a period of 5 to 10 years of follow-up. The study should be randomized, stratified according to prior treatment, and of sufficient size to detect a 30% difference in cancer outcomes between the two groups. Monitoring by an independent Data Safety Monitoring Board is recommended. Given the anticipated length of the study, it is recommended that the protocol include plans to assess the adequacy of enrollment and submit interim reports of results at yearly intervals. 29-Mar-05 31-Jul-16 Ongoing
EXENATIDE A randomized and controlled pediatric study under PREA to evaluate the safety, efficacy, and pharmacokinetics of BYDUREON (exenatide extended-release for injectable suspension) for the treatment of type 2 diabetes mellitus in pediatric patients ages 10-17 years (inclusive). 27-Jan-12 31-Jul-17 Submitted
EXENATIDE A 2-year study in mice to determine the reversibility of C-cell hyperplasia, the potential of hyperplasia to progress to neoplasia, and GLP-1 receptor expression on C-cells after 6 months of treatment with exenatide for injectable suspension. 27-Jan-12 31-Mar-16 Ongoing
EXENATIDE A study to evaluate and compare GLP-1 receptor expression/density on human, rat, and mouse thyroid C-cells. This should include evaluation of mouse tissue from PMR 1860-2 following exenatide for injectable suspension treatment for 6 months as well as following 1.5 year recovery. 27-Jan-12 30-Nov-15 Ongoing
EXENATIDE A study to evaluate the dependence of the GLP-1 receptor for exenatide-induced C-cell hyperplasia and investigate the expression of growth regulatory genes in wild-type and GLP-1 receptor knock-out mice. 27-Jan-12 31-Dec-13 (original) 31-July-14 (revised) Ongoing
EXENATIDE A medullary thyroid carcinoma case series registry of at least 15 years duration to systematically monitor the annual incidence of medullary thyroid carcinoma in the United States and to identify any increase related to the introduction of BYDUREON (exenatide for injectable suspension) into the marketplace. This study will also establish a registry of incident cases of medullary thyroid carcinoma and characterize their medical histories related to diabetes and use of BYDUREON (exenatide for injectable suspension). 27-Jan-12 15-Sep-28 Ongoing
EXENATIDE A randomized, double blind, placebo-controlled trial evaluating the effect of BYDUREON (exenatide extended-release for injectable suspension) on the incidence of major adverse cardiovascular events (MACE) in subjects with type 2 diabetes mellitus (T2DM). The trial must also assess adverse events of interest including the long-term effects of BYDUREON (exenatide extended-release for injectable suspension) on potential biomarkers of medullary thyroid carcinoma (e.g., serum calcitonin) as well as long-term effects on thyroid neoplasms, pancreatitis (including hemorrhagic and necrotizing forms), pancreatic cancer, serious injection site reactions (including nodules), allergic/hypersensitivity events, serious hypoglycemia, and renal disorders. 27-Jan-12 31-Dec-18 Ongoing
EXENATIDE Deferred pediatric study under PREA for the treatment of type 2 diabetes mellitus in pediatric patients ages 10 to 16 years (inclusive). 30-Oct-09 31-Dec-10
(original date)
31-Dec-2014
(date extended)
Delayed
EXENATIDE A prospective observational cohort study to examine the incidence of pancreatic malignancy and thyroid neoplasm in patients with Type 2 diabetes mellitus initiated on Byetta compared to patients initiated on other antidiabetic agents. 30-Oct-09 30-Sep-13 Submitted
IPILIMUMAB PMR 1: To submit the final report for study DN120020 (Intravenous Study of Pre- and-Post-natal Developmental in Cynomolgus Monkeys with a 6-Month Post-natal Evaluation). 25-Mar-11 31-Dec-11 Fulfilled
IPILIMUMAB PMR 2: To develop a validated, sensitive, and accurate assay for the detection of binding antibodies to ipilimumab, including procedures for accurate detection of antibodies to ipilimumab in the presence of ipilimumab levels that are expected to be present in the serum or plasma at the time of patient sampling. 25-Mar-11 2-Dec-11 Fulfilled
IPILIMUMAB PMR 3: To develop a validated, sensitive, and accurate assay for the detection of neutralizing antibodies to ipilimumab, including procedures for accurate detection of neutralizing antibodies to ipilimumab in the presence of ipilimumab levels that are expected to be present in the serum or plasma at the time of patient sampling. In the event such an assay can not be developed, evidence of due diligence in attempting to develop the assay will be provided. 25-Mar-11 30-Jun-14 Ongoing
IPILIMUMAB PMR 4: To conduct an assessment of anti-drug antibody (ADA) response and neutralizing ADA responses to ipilimumab with a validated assay (required in PMR 2 and 3) capable of sensitively detecting ADA responses in the presence of ipilimumab levels that are expected to be present at the time of patient sampling. The ADA response will be evaluated in at least 300 ipilimumab-treated patients enrolled in the required postmarketing trial (PMR 6) comparing 3 mg/kg versus 10 mg/kg of ipilimumab monotherapy. The final report will include information on the level of ipilimumab in each patient's test sample at each sampling time point. 25-Mar-11 29-Dec-17 Ongoing
IPILIMUMAB PMR 5: During the conduct of the required postmarketing trial comparing 3mg/kg vs. 10mg/kg ipilimumab monotherapy (PMR 6), you will obtain comprehensive baseline DNA sample acquisition (≥ 95% of ITT) and conduct pharmacogenomic association analyses to assess the potential clinical utility of CD86 gene polymorphisms as genetic determinants of immune mediated adverse events. You will provide a protocol that addresses SNP selection, data analyses approaches, and other methodological issues. You will provide a Final Report including electronic datasets. 25-Mar-11 29-Dec-16 Ongoing
IPILIMUMAB PMR 6: Following the assessment of data from Trial CA184024, you will design and conduct a trial to compare the efficacy, with the primary endpoint of overall survival and the safety of ipilimumab at doses of 3mg/kg versus 10mg/kg given as monotherapy every three weeks for four doses in patients with unresectable Stage III or Stage IV melanoma. 25-Mar-11 31-Dec-17 Ongoing
IPILIMUMAB PMC 7: To identify further genetic determinants of immune-mediated adverse events caused by ipilimumab. DNA samples from the required postmarketing study comparing 3 mg/kg vs. 10 mg/kg ipilimumab monotherapy will be used to conduct genome-wide association analyses. The design of these analyses will be reviewed by FDA and a final report with electronic datasets will be provided. 25-Mar-11 31-Dec-18 Ongoing
SAXAGLIPTIN PMR 1493-1: Deferred randomized and controlled pediatric study under PREA to evaluate efficacy, safety, and pharmacokinetics of saxagliptin for the treatment of type 2 diabetes mellitus in pediatric patients ages 10 to 16 years. Final Report Submission: by June 30, 2015 Submit all final reports to this NDA. 31-Jul-09 30-Jun-18 Ongoing
SAXAGLIPTIN PMR 1493-6 A randomized, double-blind, controlled trial evaluating the effect of saxagliptin on the incidence of major adverse cardiovascular events in patients with type 2 diabetes mellitus. The primary objective of this trial is to establish that the upper bound of the 2-sided 95% confidence interval for the estimated risk ratio comparing the incidence of major adverse cardiovascular events observed with saxagliptin to that observed in the control group is less than 1.3. Secondary objectives must include an assessment of the long-term effects of saxagliptin on lymphocyte counts, infections, hypersensitivity reactions, liver, bone fracture, pancreatitis, skin reactions, and renal safety. For hypersensitivity reactions, especially angioedema, reports should include detailed information on concomitant use of an angiotensin-converting enzyme inhibitor or an angiotensin-receptor blocker. 31-Jul-09 31-Jan-16 Ongoing
For cases of pancreatitis, serum amylase and/or lipase concentrations with accompanying normal ranges and any imaging study reports should be included in the narratives. Because renal impairment is an important complication of diabetes, you must ensure that there is a minimum of 1 year of exposure for at least 200 saxagliptin-treated patients with moderate renal impairment and at least 100 saxagliptin-treated patients with severe renal impairment. Final Protocol Submission: by November 30, 2009; Study Completion: by July 31, 2015 Final Report Submission: by January 31, 2016
SAXAGLIPTIN/ METFORMIN HYDROCHLORIDE NDA 200678 PMR 1703-1: Deferred clinical pharmacology pediatric study under PREA comparing the pharmacokinetics of Kombiglyze XR to co-administered saxagliptin and metformin IR tablets with evaluation of whether pediatric patients can safely swallow Kombiglyze 1000 mg XR tablets in pediatric patients ages 10 to 17 years. 5-Nov-10 31-Mar-15 Released Released from this PMR on 14 Nov 2013
SAXAGLIPTIN/ METFORMIN HYDROCHLORIDE NDA 200678 PMR 1703-2: Deferred randomized controlled double blinded trial under PREA to evaluate the safety and efficacy of saxagliptin vs placebo, both as add on to metformin therapy in pediatric patients with inadequate control on metformin alone with one half of the patients on metformin XR at time of randomization and with evaluation of whether pediatric patients can safely swallow 1000 mg Kombiglyze XR tablets in pediatric patients ages 10 to 17 years. 5-Nov-10 30-Jun-18 Ongoing
 
 
 
 


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