Neoplasms

Digestive System Diseases

All Conditions

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

A decision support intervention that is a literacy sensitive paper based tool with educational information targeted to the patient's age and gender.

The placebo comparator is an attention control with information about driving tips for drivers age 65 and older.

Targeted by age and gender with 3 components.

1. Educational component
2. Values clarification exercise
3. Individualized decision making worksheet

The intervention or control condition is administered before the index visit with the patient's provider.

Making A Decision About CRC Screening

This text booklet is provided as an attention control for those in the control arm and like the intervention is administered prior to the index visit with the patient's provider.

Drivers 65 Plus

Carmen L Lewis, MD, MPH

Rowena J Dolor, MD, MHS

The purpose of this research study is to explore ways to improve appropriate colorectal cancer (CRC) screening in the elderly by attempting to target screening in those most likely to benefit and avoiding screening in those least likely to benefit.

The investigators propose a randomized controlled trial at the patient level to determine the efficacy of a colorectal cancer screening decision support intervention for patients ages 70 to 84 within a clinical setting. The investigators hypothesize that the use of the intervention will prepare patients for individualized decision making with their providers and result in an improvement in appropriate CRC screening decisions and screening outcomes. To assess appropriate CRC screening decisions and screening, the investigators will use a classification scheme derived from the literature based on age and the Charlson Comorbidity Index. Using this scheme, appropriate screening will include screening for those in the best health because they are likely to benefit, no screening for those in the worst health because they are unlikely to benefit, and evidence of a discussion about CRC screening for those in the intermediate health group because the benefit is unclear.

Elders Preferences in Care Decisions

Improving Appropriate Colorectal Cancer Screening in Elderly Patients

The proportion of participants classified as having appropriate colorectal cancer screening in the intervention group compared to the control group. Appropriate screening is a combined outcome measure using patient report of completion or non-completion of CRC screening tests and patient report of discussions about CRC screening with their provider at the index visit. The outcome will be measured six months after the index visit. The index visit is the patient/provider visit that occurred after the decision support intervention or control condition was administered.

The proportion of participants classified as having appropriate colorectal cancer screening decisions in the intervention group will be compared to the control group. Appropriate screening decision making is a combined outcome measure using patient report of intent to complete or not complete CRC screening tests and discussions about CRC screening with their provider. This outcome will be measured immediately after the patient and provider index visit. The index visit is the patient/provider visit that occurred after the decision support intervention or control condition was administered.

For the mediation analysis covariates will be evaluated as potential mediators. The potential mediators to be examined include adequate preparation for individualized decision making (adequate knowledge+ clear values); knowledge scores, screening preference before the index visit, decisional balance, reported discussion during the index visit, gender, previous screening, functional status, and literacy level.

Once we have tested our hypothesis for the main effects, we will also perform hypothesis-generating exploratory analyses to examine effect of the intervention in sub-groups of patients. We will examine the effect in the three strata (best, intermediate, worst health groups) defined by age and Charlson comorbidity score.

For this analysis, appropriate screening test completion will include stool cards for all age groups and health groups. Analyses described for the primary outcome will be performed using this classification of appropriate screening test completion.

Duke University

Agency for Healthcare Research and Quality (AHRQ)

University of North Carolina, Chapel Hill

Symptoms and General Pathology

Rare Diseases

Neoplasm Metastasis

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neoplastic Processes

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

Gastrointestinal Agents

Octreotide

Antineoplastic Agents, Hormonal

Octreotide LAR 30 mg intramuscularly every 28 days

Placebo - Sodium chloride intramuscularly every 28 days

Octreotide LAR (Long-acting release)

Sodium chloride intramuscularly every 28 days

Placebo

Rudolf Arnold, MD, Prof

Placebo-controlled prospective randomized phase III study to investigate the antiproliferative effect of octreotide in patients with metastasized neuroendocrine tumors of the midgut

Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut

Study to Investigate the Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut

Median time to tumor progression at the time of the planned interim analysis that includes all data observed until June 2008.

Carmen Schade-Brittinger

Sponsor-representative

Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days

Octreotide LAR (SMS995)

Total

Age, Continuous

Sex: Female, Male

Conservative Intent to Treat (ITT) population consisting of all participants who received study drug. 3 participants in the Octreotide group and 1 participant in the placebo group without liver involvement at the beginning of the study were excluded from this analysis.

Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)

Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals

Biochemical Response at 3 Month Intervals

Symptom Control at 3 Month Intervals

Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study

Survival

Overall Study

Blood and Lymph Conditions

Syndrome

Leukemia

Preleukemia

Myelodysplastic Syndromes

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Leukemia, Myelomonocytic, Acute

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Leukemia, Myeloid

Myeloproliferative Disorders

Myelodysplastic-Myeloproliferative Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Acute Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Myelodysplastic/myeloproliferative Disease

Azacitidine

Antimetabolites

Enzyme Inhibitors

Azacitidine 75 mg/m2 IV on days 1-5, 8 \& 9 OR days 1-7 and birinapant 13 mg/m2 IV twice a week (days 1 \& 4) for 3 out of 4 weeks

Azacitidine 75mg/m2 IV days 1-5, 8 \& 9 OR days 1-7 and placebo IV twice a week (days 1 \& 4) for 3 out of 4 weeks

birinapant

This is a randomized double blind placebo controlled study of azacitidine with or without birinapant in subjects with higher risk Myelodysplastic syndrome, secondary MDS or myelomonocytic leukemia (CMMoL) who are naïve, to azacitidine therapy. Pre-clinical and mechanistic studies support that azacitidine may modulate pathways that enable birinapant-mediated anti-tumor activity.

This is a randomized double blind placebo controlled study of azacitidine with or without birinapant in subjects with higher risk Myelodysplastic syndrome, secondary MDS or myelomonocytic leukemia (CMMoL)

The primary purpose of this study is :

-To compare the relative effect of azacitidine plus birinapant versus azacitidine plus placebo on response rate in patients with higher-risk MDS, secondary MDS or CMMoL.

The secondary purpose of this study is to compare effect of azacitidine plus birinapant relative to azacitidine with placebo on:

* Hematologic improvement
* Relapse free survival
* Time to respond
* Change in transfusion requirements
* Duration of response
* Overall survival
* Adverse events

The exploratory objective of this study is to assess exploratory translational biomarkers for antitumor effects.

Study of Azacitidine With or Without Birinapant in Subjects With MDS or CMMoL

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Azacitidine With or Without Birinapant With a Single Arm Open-Label Run-In Phase in Subjects With Higher Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

TetraLogic Pharmaceuticals

Nervous System Diseases

Immune System Diseases

Sclerosis

Multiple Sclerosis

Multiple Sclerosis, Chronic Progressive

Atrophy

Autoimmune Diseases

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Demyelinating Diseases

Channel Blockers

Natriuretic Agents

Psychotropic Drugs

Anticonvulsants

Neuroprotective Agents

Amiloride

Fluoxetine

Riluzole

Selective Serotonin Reuptake Inhibitors

Serotonin

Neurotransmitter Agents

Antidepressive Agents

Cytochrome P-450 Enzyme Inhibitors

Excitatory Amino Acid Antagonists

Protective Agents

Diuretics

Sodium Channel Blockers

Diuretics, Potassium Sparing

Amiloride 5 mg twice per day (5 mg once per day for first 4 weeks) for 96 weeks

Riluzole 50 mg twice per day (50 mg once per day for first 4 weeks) for 96 weeks

Fluoxetine 20 mg twice per day (20 mg once per day for first 4 weeks) for 96 weeks

Matched placebo 1 capsule twice per day (1 capsule a day for first 4 weeks) for 96 weeks

Jeremy Chataway

Siddharthan Chandran

Multiple sclerosis (MS) is a disabling and progressive neurological disease that affects approximately 100,000 people in the UK. Many patients with MS experience two phases of disease; early MS (also called relapsing remitting MS, RRMS) and late MS (also called secondary progressive MS (SPMS). Early MS is due to inflammation of the nerves and the insulation (called myelin) that surrounds the nerves. Early MS is often characterised by periods of "attacks" interspersed with periods of "remission" with no or low disease symptoms. Late or progressive MS, which affects the majority of patients and typically emerges after 10-15 years of disease, results from actual nerve death (also called neurodegeneration). The progressive stage of disease results not in individual attacks but slow, cumulative and irreversible disability affecting walking, balance, vision, cognition, pain control, bladder and bowel function. Critically, and unlike early disease, there is no proven treatment for the late stage of MS. This is therefore an urgent and major unmet health need. MS-SMART directly addresses this need and will evaluate in this clinical trial three drugs (fluoxetine, riluzole or amiloride), all of which have shown some promise in MS, and in particular in SPMS. The trial is randomised and blinded. Randomisation means patients can get any one of the three active drugs or the inactive placebo/dummy; blinded means that neither patients nor the doctors will know which drug or placebo patients are receiving. Randomisation and blinding are standard approaches in clinical trials to ensure unbiased testing of drugs. All patients in MS-SMART will have periodic MRI (magnetic resonance imaging) brain scans and after 96 weeks these will be analysed. We will then compare the scans of each drug to the placebo or dummy to see if any of the drugs slow the rate of brain shrinkage that normally occurs in SPMS. This measured change in brain size is the primary (major) outcome of MS-SMART.

MS-SMART will test the efficacy and mechanism of action of three repurposed drugs (fluoxetine, riluzole and amiloride). All three drugs are in human use and have a good safety record. Critically for the purpose of MS-SMART they all have shown promise in early phase human MS clinical trials and target one or more of the pivotal neurodegenerative causing pathways implicated in SPMS. This is a Type B trial, as the IMPs are all in human use, have a good safety profile but are not currently used for this patient population.

The major need for patients with established and progressive MS is neuroprotective or disease modifying treatments that will slow or even stop disease progression. This study will evaluate three highly promising putative neuroprotective drugs as well as comprehensively address several of the current knowledge gaps related to the understanding of neuroprotection and neurodegeneration in SPMS through MRI and CSF examination.

MS-SMART is a multicentre, multi-arm, double blind, placebo-controlled phase IIb randomised controlled trial. A total of 440 patients with SPMS, with an entry criteria of an EDSS score of 4.0-6.5 will be equally randomised to receive placebo or one of the three active agents (fluoxetine 20mg bd, amiloride 5mg bd or riluzole 50mg bd). Patients will be followed up for 96 weeks with outcome-data collected after 0, 24, 48 and 96 weeks. That is, the duration of the trial for a trial participant is 96 weeks (a telephone assessment at week 100, 4 weeks post completion will be conducted). This is standard practice for phase II trials in SPMS.

MS-SMART: Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial

A Multi-arm Phase IIB Randomised, Double Blind Placebo-controlled Clinical Trial Comparing the Efficacy of Three Neuroprotective Drugs in Secondary Progressive Multiple Sclerosis.

Persistent new T1 hypointense lesion count to assess neuroprotection in new lesions.

Grey matter volume change to assess cortical neuroprotection.

MR spectroscopy (MRS) to measure N-acetyl aspartate (reversal of neuronal mitochondrial dysfunction), myoinositol (prevention of glial cell inflammation) and glutamate (prevention of excitotoxicity).

Magnetic Transfer Ratio (MTR) to evaluate myelination.

Cervical cord imaging to assess cord neuroprotection.

Composite MRI/disability scores to increase sensitivity and study interaction of treatment mechanisms.

Quantification of Cerebrospinal fluid (CSF) neurofilament levels to measure neuroprotection.

Optical Coherence Tomography (OCT) measured Retinal Nerve Fibre Layer (RNFL) thickness as a measure of neuroprotection.

To establish whether a drug, from a panel of 3 leading candidate neuroprotective drugs, slows the rate of brain volume loss in SPMS over 96 weeks using MRI-derived percentage brain volume change (PBVC).

To establish that a multi-arm trial strategy is an efficient way of screening drugs in SPMS and can become the template for future work.

To explore any anti-inflammatory drug activity using the count of new and enlarging T2 lesions.

Examining for evidence of pseudo-atrophy (to ensure reliability of the primary outcome measure).

To examine the clinical effect of neuroprotection as measured by clinician - EDSS, MSFC, SDMT, SLCVA, relapse rate and patient reported outcome measures - MSIS29 v2, MSWS v2, Pain - NPRS and BPI and Fatigue - NFI.

To collect basic health economic data (EQ-5D) to inform future phase III trials.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Elders Preferences in Care Decisions	NCT01575990	Early Detection... Colon Cancer Decision Making Patient-Centere...	Making A Decisi... Drivers 65 Plus	70 Years - 84 Years	University of North Carolina, Chapel Hill
Elders Preferences in Care Decisions	NCT01575990	Early Detection... Colon Cancer Decision Making Patient-Centere...	Making A Decisi... Drivers 65 Plus	70 Years - 84 Years	University of North Carolina, Chapel Hill
Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut	NCT00171873	Neuroendocrine ...	Octreotide LAR ... Placebo	18 Years -	Philipps University Marburg Medical Center
Study of Azacitidine With or Without Birinapant in Subjects With MDS or CMMoL	NCT02147873	Myelodysplastic... Chronic Myelomo...	birinapant Azacitidine Placebo	18 Years -	TetraLogic Pharmaceuticals
MS-SMART: Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial	NCT01910259	Secondary Progr...	Amiloride Riluzole Fluoxetine Placebo	25 Years - 65 Years	University College, London

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