A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer
This Phase 3 clinical trial is an essential step in the evaluation of an investigational
medication to see if it may be useful in treating prostate cancer. The purpose of the SPARTAN
study is to compare the safety and effectiveness of the investigational medication to placebo
in delaying prostate cancer from spreading to other parts of the body. A placebo is a pill
that looks like the investigational medication but does not contain any active medication, a
dummy pill.
Phase 3 studies are performed after preliminary evidence suggesting effectiveness of the drug
has been obtained in previous Phase 2 studies. These studies are intended to gather the
additional information about effectiveness and safety that is needed to evaluate the overall
benefit-risk relationship of the drug.
Study participants will take the oral investigational medication daily. One cycle of study
treatment lasts 4 weeks or 28 days. The number of cycles will depend on how you and your
cancer respond to the study medication.
In order for the researchers to evaluate and compare the study results, there are two
different study groups. Study participants will be randomly (like flipping a coin) assigned
to one of these groups:
- One group will receive their current treatment along with the investigational medication
- One group will receive their current medications along with a placebo
The investigational medication will be given to 2 out of every 3 study participants. Neither
you nor the study staff will know which group you are in. However, in case of a medical
emergency, your study doctor can quickly find out which treatment group you are in.
All participants will continue to receive their current treatment along with either the
investigational medication or a placebo. The selections will be random, and you may remain on
investigational treatment until your disease worsens, or until significant side effects occur
or you can no longer tolerate treatment.
A Randomized, Blinded, Placebo-controlled, Phase II Trial of LEE011 in Patients With Relapsed, Refractory, Incurable Teratoma With Recent Progression
Safety follow-up: After discontinuation of study treatment, all subjects were followed for
safety for 30 days except in the case of death, loss to follow up, withdrawal of consent, or
discontinuation of study treatment to enroll in the ribociclib rollover clinical trial
(CLEE011X2X01B).
Disease progression follow-up: Subjects who discontinued study drug for any reasons other
than disease progression were followed for efficacy every 8 weeks during the first 12 months.
After 12 months, they were followed for every 12 weeks until disease progression, death,
discontinuation from the study for any other reason (i.e. loss to follow-up or withdrawal of
consent), the initiation of a new antineoplastic treatment, or until all subjects had been
followed for at least 18 months after their first dose of study drug, or early study
termination, whichever occurred first.
Survival follow-up: All subjects were followed for survival via a phone call (or during a
clinic visit) every 12 weeks and up to one additional time per quarter if a survival update
was required to meet safety or regulatory needs. The safety follow-up was carried out until
any of the following occurred (whichever occurred first): death, withdrawal of consent, loss
to follow-up, at least 18 months had elapsed from when the last subject had started
treatment, or when 80% of subjects had died or were lost to follow-up, or early study
termination.
A Long-Term Follow-Up Study to Evaluate the Durability of Virologic Response and/or Viral Resistance Patterns of Subjects With Chronic Hepatitis C Who Have Been Previously Treated With MK-5172 in a Prior Clinical Trial
As of Amendment 03, the study design is revised such that continued enrollment will only be
for participants who failed prior therapy with a grazoprevir regimen. Participants with CKD
enrolled from MK-5172-052 (NCT02092350) will continue enrollment regardless of prior
treatment-response and remain in this study for five years, while participants enrolled from
all other studies with HCV RNA less than the lower limit of quantitation (LLOQ) will be
discontinued and end their participation after the next scheduled visit. In addition,
participants who receive other HCV treatments concurrent with this follow-up study or
received other HCV treatments prior to this study will be discontinued and their data
excluded from analysis.
As of Amendment 04, the protocol has been updated to include enrollment of pediatric
participants from protocol MK-5172-079 (NCT03379506). Enrollment is limited to participants
who experienced virologic failure associated with 1 or more treatment-emergent resistant
associated substitutions (RASs) present at 12 weeks after receiving grazoprevir treatment in
prior treatment study MK-5172-079 (NCT03379506).
A Phase III, Open-Label, Extension Trial of ECU-MG-301 to
Evaluate the Safety and Efficacy of Eculizumab in Subjects with Refractory Generalized
Myasthenia Gravis (gMG).
This is a phase III, open label, extension trial of ECU-MG-301(HS-13-00805) to evaluate the safety and efficacy of Eculizumab in subjects with refractory generalized myasthenia gravis (gMG). Eculizumab is a humanized monoclonal antibody that was derived from the murine anti-human C5 antibody m5G1.1. Myasthenia Gravis is a rare, debilitating, acquired autoimmune disease of the neuromuscular junction (NMJ), clinically characterized by weakness and fatigability of skeletal muscle. Since complement activation plays a pivotal role in the pathophysiology of MG, eculizumab, a terminal complement inhibitor, as such may benefit patients who continue to have generalized weakness and bulbar signs and symptoms despite current standard of care.
The primary objective of this trial is to evaluate the long-term safety of eculizumab in subjects with refractory gMG. Subjects who complete the 26-week treatment period (Visit 17) in the ECU-MG-301(HS-13-00805) trial may potentially enter this extension trial. There will be 3 periods in this study, Blind Induction Phase, Open-Label Maintenance Phase and Safety Follow-up Period. To preserve the blinded nature of the ECU-MG-301 trial, all subjects must undergo a blind induction phase and will receive blinded Investigational Product (IP) weekly for four (4) doses. Patients who were randomized to the placebo arm in the ECU-MG-301 trial will receive 4 vials IP (3 vials/900 mg eculizumab plus 1 vial placebo) at Visits 1 to 4. Patients who were randomized to the eculizumab arm in the ECU-MG-301 trial will continue to receive 4 vials IP (1200 mg eculizumab) every two weeks at Visits 1 and 3 and placebo at Visits 2 and 4. All subjects will receive open-label eculizumab (4 vials/1200 mg) every 2 weeks during the open level maintenance phase. On-Trial Rescue Therapy (high dose corticosteroid,plasmapheresis /plasma exchange (PE) or Intravenous Immunoglobulin,) will be allowed if a subject experiences clinical deterioration as defined in this protocol. For a subject who is discontinued from this trial, a follow-up visit for safety evaluation will be required. Primary efficacy endpoint is Safety and tolerability of eculizumab. Secondary Efficacy Endpoints will include the total change of QMG (Quantitative Myasthenia Gravis) score and total change of Myasthenia Gravis Composite (MGC) score. Safety analyses will be performed on the Safety Population and the Extension Safety Population includes all subjects who receive at least 1 dose of IP (eculizumab or Placebo). There is no interim analysis planned for this trial.
Enrolling by invitation | Myasthenia Gravis | Site Unknown
Effect of Reducing Inflammation With Low Dose Methotrexate on Inflammatory Markers and Endothelial Function in Treated and Suppressed HIV Infection
HIV-infected people taking ART have a higher than expected risk of premature CVD. Many
factors likely contribute to this risk, including chronic inflammation. Strategies to reduce
inflammation in HIV-infected people may be beneficial in reducing CVD risk, as well as other
conditions, including kidney disease, bone disease, and neurologic complications. MTX is an
anti-inflammatory medication used to treat people with rheumatoid arthritis. This study
evaluated the safety and effectiveness of LDMTX at treating inflammation and on endothelial
function in virologically suppressed HIV-infected adults who had CVD or were at increased
risk of CVD.
The total study duration was 36 weeks. Prior to enrolling in the study, participants had a
chest X-ray. Participants were randomly assigned to receive LDMTX or placebo for 24 weeks.
Participants continued taking their antiretroviral (ARV) medications as usual; ARVs were not
provided by the study. At study entry, participants underwent a medical and medication
history, physical examination, blood collection, and adherence assessments. From study entry
through Week 1, participants received either 5 mg of LDMTX or placebo once a week. For
participants who were clinically stable at the Week 1 study visit, the dose of LDMTX or
placebo was increased to 10 mg once a week through Week 12. For participants who were
clinically stable at the Week 12 study visit, the dose of LDMTX or placebo was increased to
15 mg once a week through Week 24. Participants who did not meet the criteria for dose
escalation were re-evaluated at the following study visit. In addition to LDMTX or placebo,
all participants also received 1 mg of folic acid once a day from study entry throughout Week
24. After taking the final dose of LDMTX or placebo, all participants continued taking folic
acid for an additional 4 weeks.
Post-entry visits occurred at Weeks 1, 2, 4, 8, 12, 18, 24, and 36. These included a physical
examination, blood collection, and adherence assessments; an arm ultrasound test was
performed at Weeks 12 and 24. At Week 2, some participants took part in a pharmacokinetic
(PK) assessment, which involved undergoing a blood collection several times over a 6-hour
period.
A Randomized Double-Blind Phase 2 Study Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals (Amantadine, Ribavirin, Oseltamivir Versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications
Seasonal influenza is responsible for approximately 226,000 excess hospitalizations annually
and despite effective antivirals causes significant morbidity and mortality (estimated
24,000-50,000 deaths each year in the United States alone). The influenza virus that emerged
in 2009 (A/California/07/2009 H1N1) caused fewer deaths (12,000 flu-related deaths in the
U.S) but in contrast to seasonal flu, nearly 90 percent of the deaths with the 2009 H1N1
occurred among people younger than 65 years of age. The CDC has defined an at-risk
population that is responsible for the majority of hospitalization and morbidity associated
with influenza. This study will evaluate the use of combination antivirals as compared to
oseltamivir alone in the treatment of influenza in an at-risk population.
Subjects who meet the CDC definition for being at-risk and that present with an
influenza-like illness will be screened for the study. Those subjects with a confirmatory
test for influenza (rapid antigen or PCR) will be randomized in a 1:1 manner to receive a
blinded study treatment consisting of either the combination of amantadine, oseltamivir, and
ribavirin or oseltamivir alone for 5 days. Clinical, virologic, and laboratory assessments
on Days 1, 3, 7, 14, and 28 will be used for both safety and efficacy analysis.
Objectives:
- To evaluate the effectiveness of combined treatment with oseltamivir, amantadine, and
ribavirin compared with oseltamivir alone for at-risk individuals with confirmed influenza
infection.
Eligibility:
- Individuals at least 18 years of age who have one or more medical conditions that may
cause complications from influenza, and have developed an influenza-like illness.
Design:
- Participants will be screened with a physical examination and medical history, along
with blood tests and throat swabs to confirm influenza infection.
- Eligible participants will be randomly assigned to take either oseltamivir alone (the
current standard treatment for influenza) or to take oseltamivir, amantadine, and
ribavirin. Participants will have additional blood samples and throat swabs taken at
the start of the study, and will be shown how to complete a study diary at home.
- Participants will receive a study medication kit containing the medication to take at
home twice a day for 5 days.
- Participants will return, with the medication kit, to the clinic on days 1 (the first
day after the start of the study), 3, 7, 14, and 28. The first visit may take 2 to 3
hours, but each subsequent visit should take approximately 1 to 2 hours. Additional
blood samples and throat swabs will be taken at these visits.
A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer
OBJECTIVES:
Primary
- To compare disease-free survival of patients with resected stage III colon cancer
treated with adjuvant FOLFOX chemotherapy comprising oxaliplatin, fluorouracil, and
leucovorin calcium with versus without celecoxib.
Secondary
- To contribute to an international prospective pooled analysis comparing disease-free
survival of patients treated with these regimens.
- To compare overall survival at 3 years of patients treated with these regimens.
- To contribute to an international prospective pooled analysis comparing disease-free
survival of patients treated with 6 versus 12 courses of FOLFOX chemotherapy.
- To assess toxicities of celecoxib as maintenance adjuvant therapy in these patients.
- To assess differences in cardiovascular-specific events in patients treated with versus
without celecoxib.
- To evaluate differences in toxicities, particularly cumulative peripheral neuropathy,
in patients treated with 6 versus 12 courses of FOLFOX chemotherapy.
OUTLINE: This is a multicenter study. Patients are stratified according to number of
positive lymph nodes* (1-3 vs 4 or more) and concurrent regular low-dose of aspirin (yes vs
no). Patients are randomized to 1 of 4 treatment arms.
NOTE: *Patients with N1c-only disease (i.e., no positive nodes but N1c disease by AJCC 7)
should be stratified to 1-3 nodes.
- Arm I: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2
hours, and fluorouracil IV continuously over 46-48 hours (FOLFOX) on day 1. Patients
also receive oral celecoxib once daily on days 1-14 beginning on day 1 of course 2 of
FOLFOX. Courses repeat every 14 days for 12 courses in the absence of disease
progression or unacceptable toxicity.
- Arm II: Patients receive FOLFOX as in arm I and oral placebo once daily on days 1-14
beginning on day 1 of course 2. Courses repeat every 14 days for 12 courses in the
absence of disease progression or unacceptable toxicity.
- Arm III: Patients receive FOLFOX and celecoxib as in arm I. Courses repeat every 14
days for 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm IV: Patients receive FOLFOX and placebo as in arm II. Courses repeat every 14 days
for 6 courses in the absence of disease progression or unacceptable toxicity.
In all arms, treatment with celecoxib or placebo continues for 3 years in the absence of
disease progression or unacceptable toxicity.
Blood and tissue samples maybe collected for biomarker analysis and pharmacogenomic studies.
After completion of study therapy, patients are followed up every 3 months for 1 year, every
6 months for years 2-3, and then annually for 3 years.
Not recruiting | Colon / Rectal Cancer | Multisite
18F-FMAU for Imaging in Cancer Patients
PRIMARY OBJECTIVES:
I. To determine the radiation dosimetry of 18F-FMAU in humans, confirm absence of adverse
events in humans from intravenous (i.v.) injection of 18F-FMAU for PET imaging, and
characterize the incidence of circulating metabolites of 18F-FMAU in humans.
II. To simply find out whether there is any visual uptake change of 18F-FMAU in tumors
post-therapy.
OUTLINE:
Patients receive fluorine F 18 d-FMAU IV followed by PET/CT prior to start of cancer
treatment. Patients may undergo 2 additional scans at one week prior to second course of
chemotherapy and after completion of cancer treatment depending on cancer type.
Phase II Trial of Metronomic Capecitabine and Cyclophosphamide With Lapatinib and Trastuzumab in Patients With HER2 Positive Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-Based Regimen
PRIMARY OBJECTIVES:
I. To estimate the progression free survival (PFS).
SECONDARY OBJECTIVES:
I. To evaluate the overall response rate (ORR).
II. To evaluate the clinical benefit rate (CBR; complete response, partial response, and
stable disease for >= 24 weeks).
III. To estimate the overall survival (OS).
IV. To assess the safety and tolerability.
OUTLINE:
Patients receive capecitabine orally (PO) once daily (QD), cyclophosphamide PO QD, and
lapatinib ditosylate PO QD on days 1-21 and trastuzumab intravenously (IV) on day 1. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year.
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