A Phase 1b Study of TAK-700 in Postmenopausal Women With Hormone-receptor Positive Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01808040|
Recruitment Status : Completed
First Posted : March 8, 2013
Last Update Posted : September 21, 2017
In this study the investigators want to find out about the effects of this drug in women with metastatic breast cancer. The study has two major parts; dose escalation and dose expansion. In the first part or dose escalation, subjects will be treated at the lowest dose effective in men: 300 mg two times daily. Orteronel (TAK-700) will be increased to reach the highest dose tolerated in men: 400 mg two times daily. This part of the study is designed to see if female subjects can safely tolerate orteronel (TAK-700), and to measure the changes in estrogens and androgens at different levels of TAK-700.
In the second part of the study (dose expansion), seven women will be treated with the dose identified in the first part of the study as being safest and most effective. In this part of the study, the investigators want to see if orteronel (TAK-700) will routinely and significantly decrease the estrogen levels at the dose which will be used for any future studies.
|Condition or disease||Intervention/treatment||Phase|
|Post Menopausal, Hormone Receptor Positive Breast Cancer||Drug: TAK700||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Study of TAK-700 in Postmenopausal Women With Hormone-receptor Positive Metastatic Breast Cancer|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||December 9, 2016|
Tak700 (orteronel) dose escalation schedule:
dose is dependant on dose escalation timepoint and dose expansion cohort dose will be the RP2D determined based on the dose escalation cohort final dose recommendation
Other Name: Orteronel
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability as a way to determine the recommended phase 2 dose. [ Time Frame: one year ]Determine the RP2D of orteronel in postmenopausal women with hormone-receptor positive (HR+) metastatic breast cancer.
- decrease in serum estradiol level [ Time Frame: one year ]To demonstrate clinically significant decrease in serum estradiol following treatment with orteronel at RP2D in postmenopausal women with HR+ metastatic breast cancer.
- Overall Response Rate [ Time Frame: one year ]Determine the overall response rate (ORR) and disease control rate (DCR) for orteronel in all patients treated with orteronel on protocol
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: one year ]Determine toxicity of orteronel in patients being treated at the RP2D
- pharmacodynamic activity of orteronel with steroid and endocrine levels [ Time Frame: two years ]Demonstrate the pharmacodynamic activity of orteronel by assessing steroid hormone and other endocrine levels before and following administration of orteronel.
- response rate, progression-free survival and time to progression [ Time Frame: 2 years ]To determine the ORR, DCR, progression-free survival (PFS) and time-to-progression (TTP) in HR+ metastatic breast cancer patients receiving orteronel in the dose-expansion cohort
- assess changes in serum estrogen, progesterone, androgen and other hormones [ Time Frame: 2 years ]Assess changes in serum estrogen, progesterone, androgen and other hormones in response to orteronel, and correlate tumor response to orteronel with reduction in serum levels of estrogens and androgens. See Table 4-1 and 4-2 for planned steroid hormone and other endocrine levels.
- Response to orteronel with AR and ER alpha expression [ Time Frame: 2 years ]Correlate response to orteronel with tumor expression of androgen receptor (AR), estrogen receptor alpha (ERα), and progesterone receptor (PgR), determined by immunohistochemistry (IHC) in primary and/or metastatic biopsies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808040
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Amye J Tevaarwerk, MD||University of Wisconsin, Madison|