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Phase 2 Combination Trial of Tivozanib and Enzalutamide in Men With Advanced Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Phase 2 Combination Trial of Tivozanib and Enzalutamide in Men With Advanced Prostate Cancer

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 medication, enzalutamide, will be taken every day throughout each

Patients will be given a Study Drug Administration Diary to keep a brief record of
medication administration, and to record any side effects or symptoms.

Patients will be seen in the clinic at the beginning of each cycle (every 4 weeks). During
each visit they will have the following procedures: medical history, vital sign
measurements, complete physical examination, performance status, routine blood tests, urine
sample, prostate specific antigen (PSA) test, assessment of tumor, review of study drug
administration diary, and review of current medications.

About four weeks after stopping the study drug patients will be asked to return to the
research clinic for a final study visit. The following procedures will be done: medical
history, vital sign measurements, brief physical examination, electrocardiogram, review of
other medications used since the last visit, routine blood tests, urine sample and a review
of any changes in health.

Inclusion Criteria:

- 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 Criteria:

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Description:

The primary objective of this study will be to demonstrate an improvement in progression free survival in men with metastatic castration resistant prostate cancer (mCRPC) treated with tivozanib and enzalutamide.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

M. Dror Michaelson, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

June 2013

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Metastatic
  • Prostatic Neoplasms



Massachusetts General HospitalBoston, Massachusetts  02114-2617