Opioid Growth Factor (OGF) and Gemcitabine: Novel Treatment for Pancreatic Cancer

Plain-language guide to NCT00783172: phase 1 interventional trial of Met-Enkephalin (Opioid Growth Factor), 4 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00783172
Phase: phase 1
Status: terminated early
Start: 2009-01
Completion (planned or actual): 2010-08
Participants: 4 (actual)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Pancreatic Cancer
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 1 trial, researchers set out to test Met-Enkephalin (Opioid Growth Factor).

The study includes two aims, the first is to evaluate the safety and toxicity of the combination of OGF and gemcitabine chemotherapy.

It had 1 arm (groups): OGF & Gemcitabine (experimental).

The registry classes the interventions as biological and drug.

Who Took Part

4 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Unresectable and histological or cytological confirmation of adenocarcinoma of the pancreas and measurable disease by CT scan.

The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: uncontrolled cardiovascular disease (congestive heart failure, symptoms of coronary artery disease, cardiac arrhythmias); suffered from myocardial infarction in preceding 6 months; pregnant or nursing women.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Met-Enkephalin (Opioid Growth Factor) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2009-01 with completion listed for 2010-08.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: progression measured with CT scan (time frame: every 8 weeks).

What This Means in Plain Language

Put simply, this is a phase 1 trial of Met-Enkephalin (Opioid Growth Factor) in 4 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Met-Enkephalin (Opioid Growth Factor) compound page, all human trials.

Our Notes on the Compound

Met-Enkephalin (Opioid Growth Factor): A 5-amino-acid natural opioid peptide; studied as "opioid growth factor" in a small number of trials.

Met-Enkephalin (Opioid Growth Factor) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.