Status:
TERMINATED
Tivozanib + Enzalutamide in Adv Prostate Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Comprehensive Cancer Network
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational combination of drugs to learn whether they work in treating a specific cancer. "Investi...
Detailed Description
Patients will be treated in treatment cycles of 28 days (4 weeks), during which time they will take tivozanib once a day for 21 days (3 weeks) followed by a one week break from treatment. The other me...
Eligibility Criteria
Inclusion
- Adenocarcinoma of the prostate that is metastatic or unresectable and for which standard curative options do not exist
- Radiographic evidence of metastatic prostate cancer
- Progressive disease despite ongoing androgen deprivation therapy (ADT), defined as castration resistant prostate cancer (CRPC)
- Other than ongoing prior treatment with other hormonal agents such as antiandrogens or ketoconazole must have been stopped at least two weeks prior to enrollment
- Have received prior docetaxel-based chemotherapy for prostate cancer within the past 12 months. Such chemotherapy must have been stopped at least 3 weeks prior to the first dosing in this study
- Life expectancy of at least 12 weeks
- Must agree to use adequate contraception prior to study entry and for the duration of study participation
Exclusion
- Prior treatment with enzalutamide, TOK-001, or ARN-509
- Participants who have received more than two prior chemotherapy regimens for metastatic CRPC
- Receiving any other investigational anticancer agents
- Known brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to tivozanib or enzalutamide
- Radiotherapy or minor surgical procedure within 2 weeks, or major surgical procedure within 4 weeks prior to administration of first dose of study drug; inadequate recovery from prior surgical procedure
- History of seizure of condition that may predispose to seizure
- Significant cardiovascular disease
- Non-healing wound, bone fracture or skin ulcer
- Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis or other gastrointestinal condition with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to administration of first dose of study drug
- Serious/active infection or infection requiring parenteral antibiotics
- Significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug
- Currently active second primary malignancy, including hematologic malignancies, except for non-melanoma skin cancers, in situ cervical cancer, and ductal or lobular carcinoma in situ of the breast
- History of genetic or acquired immune suppression disease such as HIV; subjects on immune suppressive therapy for organ transplant
- Inability to swallow capsules, malabsorption syndrome or gastrointestinal disease that severly affects the absorption of study drugs, major resection of the stomach or small bowel, or gastric bypass procedure
- Significant bleeding disorders within 6 months prior to administration of first dose of study drug
- Psychiatric disorder or altered mental status precluding informed consent or protocol-related testing
Key Trial Info
Start Date :
September 3 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01885949
Start Date
September 3 2013
End Date
May 23 2024
Last Update
July 16 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114