Prostate CancerPhase 2NCT02452008
Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer
A Phase 2 study testing Enzalutamide and LY2157299 in people with Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 4 sites in United States.
Trial summary
The primary objective of this study is to compare the progression free survival (PFS) of patients with metastatic castration-resistant prostate cancer treated with enzalutamide in combination with LY2157299 (Arm 1) versus enzalutamide alone (Arm 2). Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Enzalutamide and LY2157299
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 May 2016to Dec 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have metastatic castration-resistant prostate cancer
- Must have had prior abiraterone treatment
- Life expectancy of greater than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2
- Age ≥18 years
- Have measurable disease
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- Patients acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator).
- Ability to take oral medication
- Patients must have adequate organ and marrow function defined by study-specified laboratory tests
- Must use acceptable form of birth control while on study
- Ability to understand and willingness to sign a written informed consent document
Who cannot join
- Known history or evidence of brain metastases
- Prior chemotherapy for metastatic disease in castration-resistant prostate cancer
- Had surgery within 4 weeks prior to the first dose of study drug
- Had radiation, biological, or other investigational cancer therapy within 2 weeks prior to the first dose of study drug
- Had second-line hormonal therapy within 2 weeks prior to the first dose of study drug
- Systemic steroids within 1 weeks prior to the first dose of study drug
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- Had prior enzalutamide, ARN-509, or galeterone therapy
- Have moderate or severe cardiovascular disease
- Have a history of a seizure
- Have uncontrolled intercurrent illness, including but not limited to ongoing or active infection, systematic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric condition that would limit compliance with study requirements
- Have a history of any autoimmune disease:inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythmatosus (SLE) autoimmune vasculitis (e.g., Wegener's Granulomatosis), central nervous system (CNS) or motor neuropathy considered to be of autoimmune origin (e.g., Guillian-Barre Syndrome, Myasthenia Gravis, Multiple Sclerosis)
- Have known history of infection with HIV, hepatitis B, or hepatitis C
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University
Baltimore, Maryland, 21205
Northwestern University
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
About this study
Official title: Overcoming Drug Resistance in Metastatic Castration-resistant Prostate Cancer With Novel Combination of TGF-β Receptor Inhibitor LY2157299 and Enzalutamide: a Randomized Multi-site Phase II Study
The primary objective of this study is to compare the progression free survival (PFS) of patients with metastatic castration-resistant prostate cancer treated with enzalutamide in combination with LY2157299 (Arm 1) versus enzalutamide alone (Arm 2).
- Conditions
- Prostate Cancer
- Being tested
- Enzalutamide, LY2157299
- Keywords
- metastatic castration-resistant prostate cancer, enzalutamide, LY2157299, TGF-β receptor inhibitor
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnzalutamideDrug
Also called XTANDI
160mg of enzalutamide is administered orally once a day on days 1-28 of each cycle.
LY2157299Drug
Also called TGF-β receptor inhibitor
150 mg of LY2157299 is administered orally twice a day on days 1-14 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Enzalutamide with LY2157299 | Experimental | Not described Receives: Drug: Enzalutamide; Drug: LY2157299 |
| Arm 2: Enzalutamide alone | Experimental | Not described Receives: Drug: Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival in Patients With Metastatic Castration-resistant Prostate Cancer Treated With Enzalutamide and LY2157299 (Arm 1) Versus Enzalutamide Alone (Arm 2) Using RECIST 1.1 Criteria.
Measured: 8 years
Secondary outcomes (3)
Number of Participants With (PSA50) Response
PSA50 response in patients with metastatic castration-resistant prostate cancer treated with enzalutamide and LY2157299
Measured: 4 years
Overall Survival (OS) in Patients With Metastatic Castration-resistant Prostate Cancer Treated With Enzalutamide and LY2157299 (Arm 1) Versus Enzalutamide Alone (Arm 2).
Measured: 8 years
Number of Patients Experiencing Treatment-related Toxicities
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study start3 May 2016
- Primary completion8 Dec 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, National Capital Foundation
- Responsible party
- Sponsor
- Investigators
- Channing Paller, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452008
- Sponsor's protocol ID
- J1557
- Other IDs
- IRB00065746
- Status last verified
- Nov 2026
- First submitted
- 20 May 2015
- Last updated
- 6 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rodriguez Y, Unno K, Truica MI, Chalmers ZR, Yoo YA, Vatapalli R, Sagar V, Yu J, Lysy B, Hussain M, Han H, Abdulkadir SA. A Genome-Wide CRISPR Activation Screen Identifies PRRX2 as a Regulator of Enzalutamide Resistance in Prostate Cancer. Cancer Res. 2022 Jun 6;82(11):2110-2123. doi: 10.1158/0008-5472.CAN-21-3565.
PubMed 35405009
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overcoming Drug Resistance in Metastatic Castration-resistant Prostate Cancer With Novel Combination of TGF-β Receptor Inhibitor LY2157299 and Enzalutamide: a Randomized Multi-site Phase II Study
- ClinicalTrials.gov ID
- NCT02452008
- Acronym / sponsor ID
- J1557
- Conditions
- Prostate Cancer
- Keywords
- metastatic castration-resistant prostate cancer, enzalutamide, LY2157299, TGF-β receptor inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, National Capital Foundation
- Study start
- 3 May 2016 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 May 2015 (estimated)
- Results
- Posted 6 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare the progression free survival (PFS) of patients with metastatic castration-resistant prostate cancer treated with enzalutamide in combination with LY2157299 (Arm 1) versus enzalutamide alone (Arm 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Enzalutamide with LY2157299 | Experimental | Drug: Enzalutamide, Drug: LY2157299 |
| Arm 2: Enzalutamide alone | Experimental | Drug: Enzalutamide |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Have metastatic castration-resistant prostate cancer
- Must have had prior abiraterone treatment
- Life expectancy of greater than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2
- Age ≥18 years
Key exclusion criteria (12 listed)
- Known history or evidence of brain metastases
- Prior chemotherapy for metastatic disease in castration-resistant prostate cancer
- Had surgery within 4 weeks prior to the first dose of study drug
- Had radiation, biological, or other investigational cancer therapy within 2 weeks prior to the first dose of study drug
- Had second-line hormonal therapy within 2 weeks prior to the first dose of study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnzalutamideAlso: XTANDI160mg of enzalutamide is administered orally once a day on days 1-28 of each cycle. | Drug | Arm 1: Enzalutamide with LY2157299, Arm 2: Enzalutamide alone |
| LY2157299Also: TGF-β receptor inhibitor150 mg of LY2157299 is administered orally twice a day on days 1-14 of each cycle. | Drug | Arm 1: Enzalutamide with LY2157299 |
Primary outcome
Progression Free Survival in Patients With Metastatic Castration-resistant Prostate Cancer Treated With Enzalutamide and LY2157299 (Arm 1) Versus Enzalutamide Alone (Arm 2) Using RECIST 1.1 Criteria.
Time frame: 8 years
3 secondary outcomes
Number of Participants With (PSA50) Response
Time frame: 4 years
Overall Survival (OS) in Patients With Metastatic Castration-resistant Prostate Cancer Treated With Enzalutamide and LY2157299 (Arm 1) Versus Enzalutamide Alone (Arm 2).
Time frame: 8 years
Number of Patients Experiencing Treatment-related Toxicities
Time frame: 8 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35405009Rodriguez Y, Unno K, Truica MI, Chalmers ZR, Yoo YA, Vatapalli R, Sagar V, Yu J, Lysy B, Hussain M, Han H, Abdulkadir SA. A Genome-Wide CRISPR Activation Screen Identifies PRRX2 as a Regulator of Enzalutamide Resistance in Prostate Cancer. Cancer Res. 2022 Jun 6;82(11):2110-2123. doi: 10.1158/0008-5472.CAN-21-3565.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Channing Paller, MD principal investigator
Johns Hopkins University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enzalutamide and LY2157299 in people with Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival in Patients With Metastatic Castration-resistant Prostate Cancer Treated With Enzalutamide and LY2157299 (Arm 1) Versus Enzalutamide Alone (Arm 2) Using RECIST 1.1 Criteria. (time frame: 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02452008, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.