Anti-tumor Activity of OSI-906
| Group | Value (months) |
|---|---|
| OSI-906 + Erlotinib + Letrozole + Goserelin | 2 |
Trial · Interventional
TerminatedPhase 2Results postedRegistry dataThis trial was stopped early.
Reason given at the registry: PI closed study early, all patients experienced severe toxicities and progressed
Results were posted for this trial.
United States
1 trial · 1 stopped early · 1 with posted results
Endocrine Therapy + OSI-906 With or Without Erlotinib for Hormone-Sensitive Metastatic Breast Cancer
NCT01205685May 2010 to Jul 2011
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Erlotinib attacks a part of cancer cells that helps them live and grow. Studies done in human beings show that this drug can make a difference in the way anti-estrogens work in hormone-sensitive breast cancers. OSI-906 attacks a different part of the cancer cell that helps them live and grow. Studies done in the laboratory show that OSI-906 can make a difference in the way anti-estrogens work in hormone-sensitive breast cancers.
Experimental
OSI-906 + Erlotinib + Letrozole + Goserelin
* OSI-906 in a pill form, by mouth, twice a day (12 hours a part) * Erlotinib in a pill form, by mouth, once a day * Letrozole in a pill form, by mouth, once a day * Goserelin, by injection once per month for women who are pre-menopausal
Outcomes the sponsor listed as primary.
Anti-tumor Activity of OSI-906
Time frame · From study entry to 6 months
Time to progression measured in months from study entry to date of disease progression
Safety Profile Based on Number of Patients With Each Worst-grade Toxicity
Time frame · Every 4 weeks up to 24 weeks
According to National Cancer Institute Common Toxicity Criteria for Adverse Events with 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening/disabling, and 5 = death.
Number of Participants With Tumor Response Per RECIST
Time frame · Every 12 weeks to tumor progression
Per RECIST criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions
Correlative Studies
Time frame · < or = to 2 weeks before initiation of Phase II study treatment period
Biomarkers associated with response to OSI-906 + Erlotinib + Letrozole + Goserelin
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (months) |
|---|---|
| OSI-906 + Erlotinib + Letrozole + Goserelin | 2 |
| Group | Value (participants) |
|---|---|
| OSI-906 + Erlotinib + Letrozole + Goserelin | 2 |
| Group | Value (participants) |
|---|---|
| OSI-906 + Erlotinib + Letrozole + Goserelin | 0 |
| Group | Value |
|---|---|
| OSI-906 + Erlotinib + Letrozole + Goserelin | not posted |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| OSI-906 + Erlotinib + Letrozole + Goserelin* OSI-906 in a pill form, by mouth, twice a day (12 hours a part) * Erlotinib in a pill form, by mouth, once a day * Letrozole in a pill form, by mouth, once a day * Goserelin, by injection once per month for women who are pre-menopausal | – | 2 / 11 | 11 / 11 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
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