Clostridium Difficile Infection (CDI)

Antibodies react with C. difficile toxin, C. difficile bacteria and spores; neutralizes the toxin and inhibit the growth of spores and vegetative forms of C. difficile

IM-01

Foothills Medical Center

Treatment of Mild-moderate Clostridium Difficile Infection (CDI)

Clinical Effectiveness of Egg-derived Polyclonal Antibodies (IM-01) for the Treatment of Mild-moderate Clostridium Difficile Infection (CDI)

Decrease the frequency of unformed bowel motions to less than 3 per day and sustain for the duration of treatment to 10-14 days.

To enumerate numbers of C.difficile present per g of stool by dilution at plate counts on CCFA or Biomerieux C. difficile Chrom Agar , Total counts on three plates express as log 10 count /g versus spore counts after alcohol shock. Toxin titers: expressed as 1/dilution of the fecale filtrate neutralized by specific anti-toxin antibodies from Tech Lab using the CCNA test. .

In those that responded to treatment with resolution of CDI, the rate of recurrence of CDI in a 30, 42 and 56 day follow up period.
• Exploratory outcome: patterns of C. difficile microbial counts and toxin titres in relationship to clinical outcomes from treatment assignments

ImmuniMed Inc.

University of Calgary

University of Manitoba

Twenty four patients in each group will receive IM-01 treatment at 20g or 10g or 5g twice daily:for 10-14 days.

Patients will be randomized 1:1:1 to receive IM-01 treatment dosage at 20g or 10g or 5g twice a day

Exocrine Pancreatic Insufficiency

The diagnosis of EPI will be made through the combination of two diagnostic tests.
The labeled triolein breath test will use criteria established by the manufacturer of the product (Pancreo-Kit®) Isomed pharma.
The fecal elastase test will be performed at our own center (Bioserv Diagnostics (BS-86-01 Elastase Pancreatic ELISA) distributed by Palex Medical.) In those cases where both results are negative, it will be considered that there is no EPI. In cases where both results are positive, the diagnosis of EPI will be performed. If the results are discordant, a Sobel test or feces quantification test will be performed.

Labeled triolein urea breath test

Prevalence of Exocrine Pancreatic Insufficiency in Patients With Decompensated Cirrhosis

The diagnosis of EPI will be made through the combination of two diagnostic tests.
The labeled triolein breath test will use criteria established by the manufacturer of the product (Pancreo-Kit®) Isomed pharma.
Reference value: Normal: > 29%; Pathological: < 29% of the fat administered
The fecal elastase test (Bioserv Diagnostics (BS-86-01 Elastase Pancreatic ELISA) distributed by Palex Medical.)
A normal result will be considered: 200 to > 500 μg / g
Slight exocrine pancreatic insufficiency- Moderate: 100 - 200 μg / g
Severe exocrine pancreatic insufficiency: <100 μg / g
In those cases where both results are negative, it will be considered that there is no EPI. In cases where both results are positive, the diagnosis of EPI will be performed. If the results are discordant, a Sobel test or feces quantification test will be performed.
Coefficient of fat absorption; Pathological if elimination > 7g of fat / day with a diet of 100g fat / day.

Jordi Sanchez-Delgado

M.D; PhD

Corporacion Parc Tauli

Patients will receive single agent carfilzomib on a weekly dosing schedule (days 1, 8, 15) in a 21 day cycle. The initial dose will be 20 mg/m² for cycle 1, day 1. Dose escalation will proceed in a standard 3+3 fashion with the requirement that dose escalation to the next level can only proceed if 0 of 3 or ≤ 1 of 6 patients experience a dose limiting toxicity (DLT). Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses.

Neoplasms

Malignancies

Carfilzomib will be given as an IV infusion over 4 hours. Subjects will remain at the clinic under observation for at least 1 hour following each dose of carfilzomib in Cycle 1 and following the dose on Cycle 2 Day 1. During these observation times, post dose IV hydration may be given at physician's discretion.

Carfilzomib

Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses.

Dexamethasone

Emory University Winship Cancer Institute

Extended Infusion Carfilzomib on a Weekly Schedule in Patients With Advanced Solid Tumors

A Phase I Study of Extended Infusion Carfilzomib on a Weekly Schedule in Patients With Advanced Solid Malignancies

Evaluate safety and tolerability of weekly dosed carfilzomib as assessed by using NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v.4 criteria to determine DLTs, the MTD, and RP2D

Pharmacokinetic analysis (Tmax, Cmax, t1/2, AUC)

Pharmacodynamic (PD) evaluation of degree of 20S proteasomal inhibition in PBMC assays conducted at Emory University before treatment and at time of first restaging scan

Objective Response Rate (CR + PR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in patients who completed at least 2 cycles of protocol therapy

Clinical Benefit Rate (CR + PR + SD) by RECIST 1.1 criteria in patients who completed at least 2 cycles of protocol therapy

chymotrypsin/caureja

Treatment of Mild-moderate Clostridium Difficile Infection (CDI)

Prevalence of Exocrine Pancreatic Insufficiency in Patients With Decompensated Cirrhosis

Extended Infusion Carfilzomib on a Weekly Schedule in Patients With Advanced Solid Tumors

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