I need some help here. I apologize if this has already been covered. I am looking at the study on the company website. I am trying to understand how many cohorts there might be if increasing doses don't produce DLT (dose limiting toxicity). The website shows an estimated Primary Completion Date of October 2013. Is this estimate based on prior nonhuman studies, and flexible based on ongoing results with successive cohorts at increased dosing levels?
From the CTIX website:
Purpose
In the laboratory, Kevetrin activates p53, a tumor suppressor protein that has an important role in protecting the body. p53 functions by activating proteins that repair DNA and kill cells that have genetic mutations such as in cancers. Research experiments showed that when cancer cells were treated with Kevetrin, it activated p53 which induced p21, a protein that inhibits cancer cell growth. p53 also induced PUMA (p53 up-regulated modulator of apoptosis), a protein that causes tumor cell death. Because of these activities, slowing cancer cell growth and causing cancer cell death, Kevetrin may help to treat tumors.
Condition Intervention Phase
Solid Tumors
Drug: thioureidobutyronitrile
Phase 1
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin (Thioureidobutyronitrile) Administered Intravenously, in Patients With Advanced Solid Tumors
Resource links provided by NLM:
MedlinePlus related topics: Cancer
U.S. FDA Resources
Further study details as provided by Cellceutix Pharmaceuticals:
Primary Outcome Measures:
Maximum Tolerated Dose (MTD) of Kevetrin [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
A dose will be declared the MTD if at least 1 patient out of 6 patients experience a dose limiting toxicity (DLT) at the highest dose level below the maximally administered dose. Once an MTD has been established, up to 12 additional patients may be enrolled at the MTD dose level for confirmation of safety.
The maximally administered dose is if 1 or more of 6 patients experience a DLT.
Dose Limiting Toxicities (DLT) of Kevetrin. [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ]
The definition of dose limiting toxicity (DLT) is in accord with the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Dose limiting toxicity will be defined as:
Grade 3 or 4 neutropenia complicated by fever, or greater than 38.5°C documented infection, or Grade 4 neutropenia of greater than 7 days duration
Grade 4 thrombocytopenia or grade 3 thrombocytopenia complicated by hemorrhage
Any grade greater than 3 non-hematologic toxicity unless there is clear alternative evidence that the adverse event (AE) was not caused by Kevetrin
Grade 3 diarrhea, nausea, or vomiting may be excluded from dose-limiting toxicities provided that the maximum time limit for supportive measures is 48 hours.
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