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ASG-5ME

Phase 1

Gastric Neoplasms | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Aug 27, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment51

FDA Designations

No designations recorded

Clinical trial landscape

ASG-5ME · 1 trial · 2 indications

Phase 1 1
NCT01166490A Phase 1 Dose Escalation Trial of ASG-5ME in Pancreatic or Gastric AdenocarcinomaGastric Neoplasms
COMPLETED51 Analytics
PHASE1COMPLETED
A Phase 1 Dose Escalation Trial of ASG-5ME in Pancreatic or Gastric Adenocarcinoma
Gastric NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events and laboratory abnormalities
Through 1 month after last dose

Secondary Endpoints

Best clinical response
Every 2 months
Overall and progression-free survival
Every month until death or study closure
Concentrations of ASG-5ME and metabolites in blood
Through 1 month after last dose
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALASG-5ME

Interventions

NameTypeDescription
ASG-5MEDRUG0.3-3.0 mg/kg IV on Days 1, 8, and 15 of 28-day cycles
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Pathologically confirmed metastatic pancreatic adenocarcinoma or pathologically confirmed AGS-5-positive gastric or gastric esophageal junction adenocarcinoma * Measurable disease (at least one nonresectable, non-nodal lesion greater than or equal to 10 mm in longest diameter ...

Countries:United States
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Frequently asked questions about ASG-5ME

What is ASG-5ME used for?

ASG-5ME is an investigational small molecule being developed for the treatment of gastric neoplasms, a type of stomach cancer. It was studied in a Phase 1 clinical trial that also included patients with pancreatic adenocarcinoma, another form of cancer.

Who makes ASG-5ME?

ASG-5ME is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in clinical development and has not been approved by regulatory authorities.

What phase is ASG-5ME in?

ASG-5ME is in Phase 1 clinical development. A Phase 1 dose escalation trial of the drug has been completed, but it remains investigational and is not yet approved for any use. Further clinical studies would be needed to establish its safety and efficacy.

What clinical trials is ASG-5ME in?

ASG-5ME has been studied in one clinical trial, identified as NCT01166490, titled 'A Phase 1 Dose Escalation Trial of ASG-5ME in Pancreatic or Gastric Adenocarcinoma.' This trial enrolled 51 participants in the United States and has been completed.

Is ASG-5ME FDA approved?

ASG-5ME is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial, but it has not received marketing approval from the U.S. Food and Drug Administration or any other regulatory agency.