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MK-2206+Endocrine Therapy in Patients With Hormone Receptor-Positive Breast Cancer
Plain-language guide to NCT01240928: phase 1 interventional trial of Goserelin. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01240928
- Phase
- phase 1
- Status
- withdrawn
- Start
- n/a
- Completion (planned or actual)
- n/a
- Participants
- n/a (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Metastatic Breast Cancer
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Goserelin.
It had 1 arm (groups): MK-2206 + exemestane +/- goserelin (experimental).
Oral MK-2206 and oral exemestane and subcutaneous goserelin (for pre-menopausal participants only).
The registry classes the interventions as drug.
More on the Plan
The phase II portion of this trial will be listed under a separate NCT number.
Who Took Part
It was open to women only 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: Female and ≥ 18 years of age on the day of signing informed consent. Performance status of 0 or 1 on the ECOG Performance Scale. Adequate organ function as indicated by the following laboratory values:. Absolute neutrophil count (ANC) ≥ 1,500 /μL. Platelets ≥ 100,000 /μL.
The full record lists 21 inclusion and 23 exclusion criteria; among the exclusions: must be at least 4 weeks post-major surgical procedure, and all surgical wounds must be fully healed; currently participating or has participated in a study with an investigational compound or device within 30 days of study day 1; primary central nervous system tumor.
How the Study Was Run
It was run as a single-group and open-label study.
Everyone knew when Goserelin 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.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 2 secondary outcomes, for example Number of participants with adverse events as a measure of safety of MK-2206 when combined with exemestane +/- goserelin.
What This Means in Plain Language
Put simply, this is a phase 1 trial of Goserelin in people.
It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Goserelin compound page, all human trials.
Our Notes on the Compound
Goserelin: A GnRH analog implant (Zoladex) used to lower sex-hormone levels in prostate and breast cancer and gynecologic conditions.
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.