Promising combo trial for prostate cancer halted early
NCT ID NCT01885949
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a combination of two drugs—tivozanib and enzalutamide—in men with advanced prostate cancer that had stopped responding to standard hormone therapy. Enzalutamide blocks male hormones that fuel cancer growth, while tivozanib cuts off the tumor's blood supply. The goal was to see if the combo could delay cancer progression longer than enzalutamide alone. However, the trial was terminated early after enrolling only 5 participants, so the results are not conclusive.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tivozanib and enzalutamide
- What this could lead to
- If it worked, this combination might delay cancer progression longer than enzalutamide alone.
- What could go wrong
- The trial was terminated early with only 5 participants, so results are very limited. Tivozanib is still investigational and may add side effects without clear benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
5 people
The number who actually took part.
- Started
-
Sep 2013
- Finished
-
May 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Other studies related to the condition(s) this trial covers.
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