A Randomized, Double-blind Phase 2 Study Comparing Gemcitabine and Cisplatin in Combination With OGX-427 or Placebo in Patients With Advanced Transitional Cell Carcinoma
Following 3 loading doses, participants receive chemotherapy and study drug on a 21-day cycle
during the Treatment Period (Chemotherapy Period) until disease progression, completion of 6
cycles, toxicity or voluntary participant withdrawal. Participants who do not have documented
disease progression and have completed a minimum of four cycles of chemotherapy continue to
receive weekly Study Drug maintenance therapy during the Maintenance Period until disease
progression or the participant fulfills one of the other reasons for withdrawal from protocol
treatment, unless they have been discontinued from protocol treatment for unacceptable
toxicity related to study drug. All participants have an End of Treatment (EOT) visit when
they are withdrawn from all study treatment (chemotherapy and maintenance). All participants
are followed until documented disease progression. Once disease progression is documented,
participants enter a Survival Follow-up Period during which data are collected regarding
further cancer therapy, secondary malignancy, and survival status.
Evaluating Nulojix Long-Term Safety in Transplant
Time Perspective: Prospective for the majority of patients who are enrolled at the time they
begin Nulojix (belatacept) treatment. Retrospective for any patients receiving Nulojix
(belatacept) prior to enrollment into ENLiST Registry
Phase II Trial of XL184 (Cabozantinib) Plus Erlotinib in Patients With Advanced EGFR-Mutant Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy
PRIMARY OBJECTIVES:
I. To evaluate for efficacy by response rate (RR) when patients with advanced non-small cell
lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) mutation who have
progressed following EGFR tyrosine kinase inhibitor (TKI) therapy are treated with XL184
(cabozantinib [cabozantinib-s-malate]) and erlotinib (erlotinib hydrochloride).
SECONDARY OBJECTIVES:
I. Determine progression free survival (PFS) for combination XL184 (cabozantinib) and
erlotinib in EGFR mutation positive patients following progression on erlotinib.
II. Assess overall survival. III. Evaluate change in tumor growth rate on XL184
(cabozantinib) and erlotinib.
IV. Evaluate type, severity, duration and outcome of toxicities. V. Correlate outcome with
tumor biomarkers such as met proto-oncogene (MET) amplification, T790M mutation, and serum
markers of the vascular endothelial growth factor (VEGF) and MET pathways in a preliminary
manner.
OUTLINE:
Patients receive cabozantinib-s-malate orally (PO) daily and erlotinib hydrochloride PO once
daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks for 1 year and
then annually thereafter.
A Randomized, Double-blind, Placebo Controlled, Parallel Group Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of QGE031 in the Treatment of Patients With Bullous Pemphigoid With Disease Refractory to Oral Steroid Treatment
This study was planned to be divided into 2 distinct parts. Part 1 was a multicenter,
randomized, placebo-controlled study evaluating the efficacy, safety, PK and PD of multiple,
subcutaneous doses of QGE031 in the treatment of patients with BP with disease refractory to
oral steroid treatment. Patients were treated with QGE031 or placebo in a 2:1 ratio.
Part 2 of this study was planned to be a multi-center, open label, dose range finding study
evaluating the efficacy, safety, PK and PD of multiple, subcutaneous doses of QGE031 in the
treatment of patients with BP with disease refractory to oral steroid treatment.
This study was stopped after Part 1 completed and was terminated because the predefined
criteria of efficacy was not reached ( >50% better then placebo)
A Randomized, Double-blind, Multicenter, Phase III Study of Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced NET of GI or Lung Origin
This was a prospective, multi-center, randomized, double-blind, parallel-group,
placebo-controlled, two-arm Phase III study comparing the efficacy and safety of everolimus
10 mg daily to placebo in patients with advanced NET of GI or lung origin without a history
of, or current symptoms of carcinoid syndrome.
After assessment of eligibility, participants qualifying for the study were randomized in a
2:1 ratio to receive either everolimus or matching placebo. Participants received daily oral
doses of 10 mg everolimus or matching placebo as study drug. In both arms, the study drug was
combined with best supportive care and treatment cycles were defined as 28 days. Participants
were treated until disease progression as per Response Evaluation Criteria In Solid Tumors
(RECIST) 1.0, intolerable toxicity, death, lost to follow-up or consent withdrawal.
Regardless of the reason for study drug discontinuation, participants had a safety follow-up
visit scheduled 30 days after the last dose of the study drug.
Per data monitoring committee recommendation, all participants on treatment with placebo were
allowed to crossover to open-label treatment with everolimus. This change was implemented
through protocol amendment 3 (issued on 06-May-2016) after which remaining participants
entered into open-label phase of the study.
A Prospective, Multi-Center, Randomized, Double-Masked, Positive-Controlled Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspension (1%) in Patients With Non-Infectious Anterior Segment Uveitis
Anterior uveitis is a disorder of the eye associated with intraocular inflammation of the
anterior portion of the uvea, particularly the iris and/or ciliary body. It is distinct from
other iterations of uveitis such as posterior, diffuse and intermediate uveitis although it
is the most common form of uveitis and accounts for approximately 75% of cases.
In a Phase 1/2 study (EGP-437-001), the delivery of EGP-437 (40 mg/mL dexamethasone
phosphate solution) at four different iontophoresis dose levels was studied in 40 subjects
with non-infectious anterior segment uveitis. The study demonstrated that a single EGP-437
treatment: lowered anterior chamber cell (ACC) scores in the majority of patients without
requiring additional treatment; produced low short-term systemic exposure to dexamethasone
and dexamethasone phosphate; and produced the most beneficial effects in the 1.6 and 4.8
mA-min dose groups; and caused mainly minor AEs and no non-ocular systemic corticosteroid
mediated effects were observed.
The Phase 3 study is intended to confirm and extend the results from the Phase 2 study. The
study is designed to assess the safety and efficacy Ocular Iontophoresis with EGP-437 4.0
mA-min at 1.5 mA and accompanying placebo eyedrops in comparison to Ocular Iontophoresis
with sodium citrate buffer solution 4.0 mA-min at 1.5 mA and accompanying prednisolone
acetate (1%) eyedrops for the treatment of non-infectious anterior segment uveitis.
PRESENT: Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer With Low to Intermediate HER2 Expressions With NeuVax™Treatment
This is a multicenter, multinational, prospective, randomized, double-blind, controlled Phase
3 study.
The subjects eligible for this trial have an early stage node-positive breast cancer. Their
tumors express low or intermediate levels of the HER2 protein. NeuVax™ will be administered
after completion of front-line, standard of care therapy (surgery, radiation therapy, and
chemotherapy) and can be given concomitantly with physician prescribed endocrine treatment.
NeuVax™ is the immmunodominant nonapeptide derived from the extracellular domain of the HER2
protein, a well-established target for therapeutic intervention in breast carcinoma. The
nelipepimut sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTL) following binding
to HLA-A2/A3 molecules on antigen presenting cells (APC). These activated specific CTLs
recognize, neutralize and destroy through cell lysis HER2 expressing cancer cells, including
occult cancer cells and micrometastatic foci. The nelipepimut immune response can also
generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope
spreading. Based on a successful Phase 2 trial, which achieved its primary endpoint of DFS,
the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for
its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer
with Low to Intermediate HER2 Expression with NeuVax Treatment) study.
The active portion of the study will last three years (36 months). The follow-up will last
from 5 to 10 years.
Endpoints:
1. Primary efficacy endpoint:
- 3-year DFS
2. Secondary efficacy endpoints:
- 5- and 10-year DFS
- 3-year OS
- 5- and 10-year OS
- Safety profile, and adverse events (AEs)
- Patterns of recurrence to include Time to recurrence (TTR), time to local
recurrence (TTLR), time to distant recurrence (TTDR), time to bone metastases
(TTBM)
Safety Assessments:
Subjects will be assessed at every study visit for the safety endpoints, AEs,vital signs,
physical examinations and laboratory data; yearly follow-up of survival will include imaging
studies, ECGs, MUGA or ECHO scans and concomitant medications.
A Phase 0, Open Label, Non-randomized, Multi-center Exploratory and Safety Study of [F-18]T807
Siemens Molecular Imaging (SMI) is seeking to determine if [F-18]T807 might be useful as a
non-invasive assessment tool in the clinical evaluation of subjects with conditions
associated with tau protein aggregates, such as Alzheimer's disease. The information
collected under this exploratory study will not be used for diagnostic purposes, assessments
of the participant's response to therapy or for clinical management of the participants.
However, this exploratory study will provide baseline information on the safety,
biodistribution, and dosimetry of [F-18]T807. These data will aid in the design of future
studies of [F-18]T807 in patients with Alzheimer's disease. Overall, this study will provide
initial data that inform the development of [F-18]T807 as the first PET imaging agent for
human tau protein related pathology.
S0910, A Phase II Study of Epratuzumab (NSC-716711) in Combination With Cytarabine and Clofarabine for Patients With Relapsed or Refractory Ph- Negative Precursor B-Cell Acute Lymphoblastic Leukemia
OBJECTIVES:
- To test whether the complete remission (CR) rate (CR and incomplete CR) in adult
patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia is
sufficiently high after treatment with cytarabine, clofarabine, and epratuzumab to
warrant further investigation.
- To estimate the frequency and severity of toxicities associated with the dosing schedule
of cytarabine, clofarabine, and epratuzumab used in this study.
- To investigate, preliminarily, the effect of laboratory correlates (minimal
post-treatment residual disease) and cytogenetic factors on prognosis in this patient
population. (Not reported here due to limited MRD data)
OUTLINE: This is a multicenter study.
Patients receive cytarabine IV over 2 hours on days 1-5, clofarabine IV over 1 hour on days
2-6, and epratuzumab IV over at least 1 hour on days 7, 14, 21, and 28 in the absence of
disease progression or unacceptable toxicity*.
NOTE: * Prophylactic intrathecal methotrexate is required for patients < 22 years of age, and
is recommended (but not required) for patients ≥ 22 years of age.
Blood samples, bone marrow samples, and/or tumor tissue samples may be collected for further
laboratory analysis.
Patients are followed up every 3 months for 2 years, then annually for 3 years (until 5 years
after registration).
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