Enzalutamide in Patients With Androgen Receptor Positive (AR+) Ovarian, Primary Peritoneal or Fallopian Tube Cancer and One, Two or Three Prior Therapies
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|ClinicalTrials.gov Identifier: NCT01974765|
Recruitment Status : Active, not recruiting
First Posted : November 4, 2013
Last Update Posted : November 15, 2018
This is a Phase II study. The purpose of this study is to find out what effects, good and/or bad enzalutamide has on the patient and the cancer. All patients who enter the study will be closely monitored for side-effects. If multiple patients develop significant side effects from enzalutamide, the study may be stopped early.
Enzalutamide is an androgen-receptor inhibitor, which means that it blocks the activity of the hormone testosterone. In ovarian, fallopian tube, and primary peritoneal cancers that express the androgen receptor, blocking the androgen-receptor may possibly slow or stop tumor growth. Enzalutamide has been studied in women with breast cancer, but this is the first study using enzalutamide for the treatment of patients with ovarian, primary peritoneal, or fallopian tube cancer.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Epithelial Ovarian Recurrent Epithelial Ovarian Fallopian Tube Primary Peritoneal Carcinoma||Drug: Enzalutamide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Enzalutamide in Patients With Androgen Receptor Positive (AR+) Ovarian, Primary Peritoneal or Fallopian Tube Cancer and One, Two or Three Prior Therapies|
|Actual Study Start Date :||November 2013|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
After signing a screening consent, patients archival tissue will be evaluated for degree of AR positivity by AR staining. Patients with no archival tissue available will undergo a biopsy (using the modality deemed most appropriate by the patient's physician) for collection of tumor tissue for AR positivity by IHC. Only AR+ patients, defined as ≥5 % positivity by IHC, will be included. All IHC testing will be performed in the MSKCC Clinical CLIA approved laboratory.
All enrolled patients will be treated with enzalutamide 160 mg by mouth QD until progression of disease (POD), unacceptable toxicity or withdrawal from study. All treatments will be administered in the outpatient setting.
All enrolled patients will be treated with enzalutamide 160mg by mouth QD. Study drugs will be self-administered by patients. A cycle is 28 days.
- complete response [ Time Frame: 6 months ]by RECIST 1.1 criteria
- partial response [ Time Frame: 6 months ]by RECIST 1.1 criteria
- adverse events [ Time Frame: every 2 weeks during the first cycle and every 4 weeks during subsequent cycles of treatment ]To determine the frequency and severity of adverse events as assessed by NCI CTCAE version 4.0.
- AR expression levels on tissue [ Time Frame: 2 years ]will be determined using standard immunohistochemistry methodology on all tissue and reported as percent tumor cells with nuclear
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): NCT01974765
|United States, New Jersey|
|Memorial Sloan Kettering Cancer Center at Basking Ridge|
|Basking Ridge, New Jersey, United States|
|Memorial Sloan Kettering Monmouth|
|Middletown, New Jersey, United States, 07748|
|United States, New York|
|Memorial Sloan Kettering Cancer Center @ Suffolk|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Westchester|
|Harrison, New York, United States, 10604|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan Kettering Cancer Center at Mercy Medical Center|
|Rockville Centre, New York, United States, 11570|
|Principal Investigator:||Rachel Grisham, MD||Memorial Sloan Kettering Cancer Center|