A Phase III, Randomized, Open Label, Multicenter, Controlled Trial of Niraparib Versus Physician's Choice in Previously-treated, HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
This is a phase III, randomized, open label, multicenter, controlled trial of niraparib
versus physician's choice in previously-treated, HER2 negative, germline BRCA
mutation-positive breast cancer patients. Niraparib is an orally active PARP inhibitor.
Niraparib (in a 2:1 ratio) will be administered once daily continuously during a 21-day
cycle. Physician's choice will be administered on a 21-day cycle. Health-related quality of
life will be measured. The safety and tolerability will be assessed by clinical review of
adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory
values.
A Multi-Center, Prospective, Randomized Study With PriMatrix Dermal Repair Scaffold Moist Wound Therapy and Standard of Care Moist Wound Therapy for the Treatment of Chronic Diabetic Foot Ulcers
This study will be a multi-center, prospective, randomized single-blinded study evaluating
the efficacy of PriMatrix MWT versus Standard of Care MWT in achieving complete wound closure
of chronic diabetic foot ulcers by 12 weeks (84 days). To measure wound recidivism and
changes in functional quality of life, each subject will complete the Cardiff Wound Impact
Schedule and the SF-36v2™ at three time points during the study i) at initial screening, ii)
at completion of treatment phase, and iii)at 24 weeks (post-randomization). Additionally, the
data obtained from the SF-36v2™ will be used in an economic evaluation of the treatment arms.
A Phase II Study of the BRAF Inhibitor Dabrafenib as a Single Agent and in Combination With the MEK Inhibitor Trametinib in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer
Subjects enrolled in Cohort A (Monotherapy Population) were required to have relapsed or
progressed on at least one platinum based chemotherapy regimen prior to enrollment (i.e.
dabrafenib was no less than second line treatment for metastatic disease). Additional lines
of prior anti-cancer therapy were allowed. Subjects received dabrafenib as a single agent at
the recommended dose of 150 mg twice daily. A 2 stage design with a planned sample size of 40
subjects was initially used for Cohort A.
Subjects enrolled in Cohort B (Combination Second-Line Population) were required to have
relapsed or progressed on at least one platinum based chemotherapy prior to enrollment but
did not receive more than 3 prior systemic anti-cancer therapies (i.e. dabrafenib/trametinib
were second, third, or fourth line treatment for metastatic disease). Subjects received the
recommended dose of both drugs (dabrafenib 150 mg twice daily and trametinib 2 mg once
daily).
Subjects enrolled in Cohort C (Combination First-Line Population) did not receive prior
systemic anti-cancer therapies for metastatic disease (i.e. dabrafenib/trametinib was first
line treatment for metastatic disease). Subjects received the recommended dose of both drugs
(dabrafenib 150 mg twice daily and trametinib 2 mg once daily).
Crossover: Subjects receiving and adequately tolerating dabrafenib as a single agent and who
continued to meet the inclusion and exclusion criteria (including the additional criteria for
combination therapy) had the option to crossover to dabrafenib (150 mg BID) and trametinib (2
mg once daily) combination treatment at the time of radiologic disease progression with prior
approval from a Medical Lead. If a subject was receiving less than 150 mg BID of dabrafenib
at the time of the crossover, the subject was to continue at the lower dose of dabrafenib
when initiating combination therapy.
A Phase II Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma
This Phase II study will enroll patients into three groups. Group 1 are patients who have
never been treated with bevacizumab. These patients will be randomly assigned to receive
either rindopepimut/GM-CSF or KLH, each along with bevacizumab. Treatment assignment for
Group 1 will be blinded. Group 2 and Group 2C patients are those who are refractory to
bevacizumab (experienced recurrence or progression of glioblastoma while on bevacizumab or
within 2 months of discontinuing bevacizumab). These patients will all receive
rindopepimut/GM-CSF along with bevacizumab. Patients will be treated until disease
progression or intolerance and all patients will be followed for survival. Patients may be
treated with other therapies that are not part of the study after discontinuing treatment
with the study vaccine.
An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma
The purpose of this research study is to find out whether adding an experimental vaccine
called rindopepimut (also known as CDX-110) to the commonly used chemotherapy drug
temozolomide can help improve the life expectancy of patients with newly diagnosed, resected
EGFRvIII positive glioblastoma.
The duration of participation in this study may be up to 5 years. After you are screened and
enrolled in the study, you will be administered temozolomide and either rindopepimut/GM-CSF
or KLH until either disease progression or intolerance to the medications. If your tumor
progresses while on this study, your doctor may treat you with other therapies that are not
part of the study.
A Phase II, Single Arm, Open Label Study of Treatment-free Remission in Chronic Myeloid Leukemia (CML) Chronic Phase (CP) Patients After Achieving Sustained MR4.5 on Nilotinib
The Primary objective was to evaluate the proportion of patients in TFR within 48 weeks
following nilotinib cessation.
This study originally consisted of seven phases (five treatment phases and two treatment-free
phases) from which two were the focus of this primary analysis report (consolidation, TFR and
treatment re-initiation) The study consisted of 2 main phases: Consolidation and TFR
Nilotinib treatment consolidation phase (NTCS): Patients who satisfied all
inclusion/exclusion criteria were enrolled in the consolidation phase and continued to
receive nilotinib for 52 weeks at the dose which the patient was receiving prior to study
entry. If a patient maintained MR4.5 throughout the consolidation phase, he/she was eligible
to enter in the TFR phase. If a patient had confirmed loss of MR4.5 during the consolidation
phase, he/she was not eligible to enter in the TFR phase and continued nilotinib treatment.
Nilotinib TFR phase: Patients who were eligible to enter in the TFR phase after completing
the 52 week consolidation phase stopped taking nilotinib on the first day of the TFR phase.
Duration of this phase was up to 520 weeks after the last patient enters in the TFR phase.
Nilotinib treatment re-initiation phase (NTRI): If a patient had a confirmed loss of MR4 (two
consecutive BCR-ABL >0.01% IS) or loss of MMR (BCR-ABL >0.1% IS) in the TFR phase, the
patient restarted nilotinib treatment. Patients will be on nilotinib treatment for up to 520
weeks after the last patient entered the nilotinib TFR phase, or until a patient experience
unacceptable toxicity, disease progression and/or treatment discontinued at the discretion of
the Investigator or if the patient withdrew consent. Nilotinib cessation was not attempted
for a second time in the patient who reinitiated treatment or discontinued following the TFR
phase.
Nilotinib treatment continuation phase (NTCT) and Nilotinib treatment prolonged continuation
phase (NTCT-P): Patients who were not eligible to enter into the TFR phase after completing
the 52-week NTCS phase entered the nilotinib treatment continuation (NTCT) phase and would
continue treatment with nilotinib for another 52 weeks (a total of 104 weeks of treatment).
Patients who were not able to maintain MR4.5 and had a confirmed loss of MR4.5 during the
NTCT phase were not eligible to enter the TFR-2 phase. These patients entered into the
nilotinib prolonged treatment continuation phase (NTCT-P) and continued nilotinib treatment
until 520 weeks after the last patient entered the nilotinib TFR phase, or until the patients
experience unacceptable toxicity, disease progression and/or treatment would be discontinued
at the discretion of the Investigator or withdrawal of consent.
Nilotinib TFR-2 phase: Patients who maintained MR4.5 during the NTCT phase were eligible to
cease nilotinib treatment and enter the TFR-2 phase. The duration of the nilotinib TFR-2
phase is up to 520 weeks after the last patient entered the TFR phase. Patients stopped
taking nilotinib therapy on the day they entered the TFR-2 phase.
Nilotinib treatment re-initiation-2 (NTRI-2): If a patient had a loss of MMR or a confirmed
loss of MR4 during the TFR-2 phase, he/she entered the nilotinib treatment re-initiation-2
(NTRI-2) phase and resumed nilotinib treatment at a dose of either 300 mg or 400 mg bid.
Safety follow-up was performed within 30 days after the last dose of study treatment or the
last day in TFR/TFR-2.
Post-treatment follow-up visits were performed every 12 weeks up to 520 weeks after the last
patient entered the nilotinib TFR phase.
Powered by
SC CTSI