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ISIS 2503

Phase 2

Pancreatic Cancer | Small molecule | Oncology |Ionis Pharmaceuticals, Inc.|Trials Updated: Jan 4, 2011

ISIS 2503 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since May 2001

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment4

FDA Designations

No designations recorded

ISIS 2503 clinical trials

ISIS 2503 · 1 trial · 1 indication

Phase 2 1
NCT00005594ISIS 2503 in Treating Patients With Advanced Cancer of the PancreasPancreatic Cancer
COMPLETED4 Analytics
PHASE2COMPLETED
ISIS 2503 in Treating Patients With Advanced Cancer of the Pancreas
Pancreatic CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary outcome measure of this study is to estimate the response rate and observe the time to tumor progression of the patients treated on this study.
24 weeks

Secondary Endpoints

Determine the duration of response in responding patients. Further characterize the safety profile of ISIS 2503 at the recommended dose and schedule.
24 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ISIS 2503EXPERIMENTALAll patients will begin treatment at a dose of 6 mg/kg/day of ISIS 2503. ISIS 2503 at the assigned dose will be given as a continuous i.v. infusion over the first 14 days of a 21-day treatment cycle. No drug will be administered during the third week of each treatment cycle.

Interventions

NameTypeDescription
ISIS 2503DRUGBeginning dosage of ISIS 2503 is 6 mg/kg/day given as a continuous i.v. infusion over the first 14 days of a 21-day treatment cycle. This will be repeated for the first two weeks of every three-week treatment cycle.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

DISEASE CHARACTERISTICS: Histologically confirmed advanced adenocarcinoma of the pancreas that is considered inoperable Measurable disease with at least 1 lesion measuring at least 2 cm in widest diameter identifiable on CT or MRI scan PATIENT CHARACTERISTICS: Age: 18 and over Performance status: E...

Countries:United States
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Competitive Landscape -Pancreatic Cancer 248 trials

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Frequently asked questions about ISIS 2503

What is ISIS 2503 used for?

ISIS 2503 was studied for the treatment of advanced pancreatic cancer. It is an investigational agent that was evaluated in a Phase 2 clinical trial in patients with advanced cancer of the pancreas. It is not an approved therapy, and no active trials of ISIS 2503 are currently listed.

Who is developing ISIS 2503?

ISIS 2503 was developed by Ionis Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker IONS. The company sponsored the clinical research evaluating the agent in pancreatic cancer.

What phase is ISIS 2503 in?

ISIS 2503 is in Phase 2 development. It has been studied in a single Phase 2 trial in advanced pancreatic cancer, and that trial is now completed. No active trials of ISIS 2503 are listed, and the agent is not approved for any indication.

What clinical trials is ISIS 2503 in?

ISIS 2503 was evaluated in one clinical trial, NCT00005594, titled "ISIS 2503 in Treating Patients With Advanced Cancer of the Pancreas." The Phase 2 study enrolled 4 patients in the United States, was uncontrolled, and is now completed.

Is ISIS 2503 FDA approved?

No. ISIS 2503 is an investigational agent and is not approved by the FDA. Its only recorded clinical study, a Phase 2 trial in advanced pancreatic cancer, has been completed, and no active trials are listed.

How many patients were enrolled in the ISIS 2503 trial?

The Phase 2 trial of ISIS 2503 in advanced pancreatic cancer, NCT00005594, enrolled 4 patients. The study was uncontrolled, was not randomized or double blinded, and has been completed.