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IGF-1 Inhibitor Pasireotide Lar in Combination With the m-TOR Inhibitor Everolimus
Plain-language guide to NCT01234974: phase 2 non-randomized trial of Pasireotide. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01234974
- Phase
- phase 2
- Status
- withdrawn
- Start
- 2010-12
- Completion (planned or actual)
- 2012-12
- Participants
- n/a (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Multiple Myeloma
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Pasireotide.
It had 1 arm (groups): Pasireotide (experimental).
The registry classes the interventions as drug.
More on the Plan
Multiple myeloma (MM) is a B-cell malignancy of plasma cells.
This provides an important opportunity to test their novel therapeutic approach, reserving SCT for relapse.
The advantage of the this strategy is that similar overall survival outcomes can be achieved with fewer patients undergoing SCT.
Who 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: Histologically documented multiple myeloma. Multiple myeloma relapsing or refractory to at least 2 of the currently accepted therapies for multiple myeloma. Age \> 18 years. Minimum of 4 weeks since any major surgery, radiation or 5 half life since prior systemic anticancer therapy. ECOG performance status ≤ 2.
The full record lists 12 inclusion and 15 exclusion criteria; among the exclusions: patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period; patients should not receive immunization with attenuated live vaccines during study period or within 1 week of study entry; patients with prior or concurrent malignancy.
How the Study Was Run
The set-up was non-randomized, single-group and open-label.
Being open-label, the Pasireotide study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2010-12 with completion listed for 2012-12.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Primary objective (time frame: 12 patients enrolled).
It also tracked 1 secondary outcome, for example Secondary objective.
What This Means in Plain Language
Put simply, this is a phase 2, non-randomized trial of Pasireotide in people.
It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Pasireotide compound page, all human trials.
Our Notes on the Compound
Pasireotide: An FDA-approved multi-receptor somatostatin analog for Cushing's disease and acromegaly; high blood sugar is a common side effect.
Related Pages
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.