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Metastatic Prostate CarcinomaPhase 1/2NCT02935205

Enzalutamide and Indomethacin in Treating Patients With Recurrent or Metastatic Hormone-Resistant Prostate Cancer

A Phase 1/2 study testing Enzalutamide and Indomethacin in people with Metastatic Prostate Carcinoma and Recurrent Prostate Carcinoma, run by Mamta Parikh at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This phase I/II trial studies the side effects of enzalutamide and indomethacin and to see how well they work in treating patients with prostate cancer that does not respond to treatment with hormones, has come back, or has spread from where it started to other places in the body. Read more about this study

Who is it for?
Ages 19 years and older, men only
What is being tested?
Enzalutamide and Indomethacin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
17 Jan 2017to Dec 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

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 19 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically or cytologically confirmed prostate cancer (CaP); CaP can be recurrent disease after definitive therapy (radical prostatectomy or radiation therapy) for localized CaP, or metastatic CaP
  • Patients must have CaP deemed to be castration-resistant by one or more of the following criteria (despite androgen deprivation when applicable):
  • Progression of unidimensionally measurable disease assessed within 42 days prior to initial administration of drug
  • Progression of evaluable but not measurable disease assessed within 42 days prior to initial administration of drug for PSA evaluation and for imaging studies (e.g, bone scans)
  • Rising PSA, defined as at least two consecutive rises in PSA to be documented over a reference value (measure 1); the first rising PSA (measure 2) should be taken at least 7 days after the reference value; a third confirmatory PSA measure (2nd beyond the reference level) should be greater than the second measure, and it must be obtained at least 7 days after the 2nd measure; if this is not the case, a fourth PSA measurement is required to be taken and be greater than the second measure
  • Measurable disease is not required
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  • Patients who have measurable disease must have had X-rays, scans or physical examinations used for tumor measurement completed within 28 days prior to initial administration of drug
  • Patients must have non-measurable disease (such as nuclear medicine bone scans) and non-target lesions (such as PSA level) assessed within 28 days prior to initial administration of drug
  • Soft tissue disease that has been radiated within two months prior to registration is not assessable as measurable disease; soft tissue disease that has been radiated two or more months prior to registration is assessable as measurable disease provided that the lesion has progressed following radiation; as the biology of previously irradiated tumors may be different from non-irradiated tumors, patients must have at least one measurable lesion outside the previously irradiated region in order to be considered to have measurable disease
  • If PSA is the only indicator of disease and patients do not have any metastatic disease, PSA value must be 5.0 or higher
  • Patients must have been surgically or medically castrated; if the method of castration was luteinizing hormone-releasing hormone (LHRH) agonists (leuprolide or goserelin) or antagonists (degarelix), then the patient must be willing to continue the use of LHRH agonists or antagonists; serum testosterone must be at castration levels (< 50 ng/dL) within 3 months prior to registration
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
  • Life expectancy of greater than 6 months
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Total bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 1.5 x institutional upper limit of normal
  • Creatinine =< 1.5 x institutional upper limit of normal
  • Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of enzalutamide administration
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Patients who are receiving any other investigational agents within the preceding 4 weeks
  • Patients on herbs or other alternative medicines for the treatment of prostate cancer, including but not limited to saw palmetto, PC-SPES
  • Patient has received enzalutamide or ketoconazole for the treatment of prostate cancer; however, previous treatment with other hormonal therapy (bicalutamide, abiraterone, flutamide, and nilutamide) or chemotherapy (docetaxel, cabazitaxel, or mitoxantrone) is allowed
  • Other malignancies within the past 3 years except for adequately treated basal or squamous cell carcinomas of the skin or other stage 0 or I cancers
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
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  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to enzalutamide or indomethacin
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
  • Patients with an active bleeding diathesis
  • History of noncompliance to medical regimens
  • Patients unwilling to or unable to comply with the protocol
  • Patients with symptomatic metastatic prostate cancer such as moderate to severe pain, impaired organ function, or spinal cord compression will be excluded from this study unless these issues have been taken care of
  • Patients with a history of seizure disorder, underlying brain injury with loss of consciousness, transient ischemic attack within the past 12 months, cerebral vascular accident, brain metastases, brain arteriovenous malformation
  • Patients with a history of peptic ulcer disease or gastrointestinal bleeding

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

    Chong-Xian Pan, 916-734-3771, cxpan@ucdavis.edu

    Chong-Xian Pan

    Recruiting

Other trials in United States

About this study

Official title: A Phase I/II Study of Enzalutamide in Combination With Indomethacin in Castration-Resistant Prostate Cancer (CRPC)

This phase I/II trial studies the side effects of enzalutamide and indomethacin and to see how well they work in treating patients with prostate cancer that does not respond to treatment with hormones, has come back, or has spread from where it started to other places in the body. Androgens can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide and indomethacin may fight prostate cancer by lowering the amount of androgen the body makes and/or blocking the use of androgen by the tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the toxicity of indomethacin and enzalutamide when given in combination, and to determine the prostate-specific antigen (PSA) response that is defined as a 50% or more reduction from the baseline.

SECONDARY OBJECTIVES:

  1. To determine the overall response as determined by the Prostate Cancer Working Group 2 criteria (PCWG2).

II. To evaluate the progression-free survival (PFS) and overall survival of castration-resistant prostate cancer (CRPC) patients treated with indomethacin and enzalutamide.

III. To evaluate molecular correlatives for patient response and outcomes through the analysis of patient baseline tumor specimens (diagnostic biopsy) along with serial blood specimens.

OUTLINE:

Patients receive enzalutamide orally (PO) once daily (QD) and indomethacin PO twice daily (BID) or QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 3 months.

Being tested
Enzalutamide, Indomethacin
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 ASP9785, MDV3100, Xtandi

    Given PO

  • IndomethacinDrug

    Also called Indocin, Indometacin

    Given PO

Study groups in NCT02935205
Study groupRoleWhat they receive
Treatment (enzalutamide, indomethacin)ExperimentalPatients receive enzalutamide PO QD and indomethacin PO BID or QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Enzalutamide; Drug: Indomethacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

    Adverse events and adverse events of grade 3 or higher will be listed for each patient and summarized by body system in a frequency table.

    Measured: Up to 3.5 years

  2. PSA response rate defined as >= 50% decrease from the baseline

    The characteristics of the study participants will be summarized using frequencies and percentages for categorical variables and descriptive statistics (mean, standard deviation, median, minimum, maximum) for numeric variables. The proportion of participants who experience a PSA response will be computed, along with the exact 95% confidence interval.

    Measured: Up to 3.5 years

Secondary outcomes (3)

  1. Overall response determined by PCWG2 criteria

    Measured: Up to 3.5 years

  2. Overall survival

    Will be estimated using the product-limit method of Kaplan and Meier; medians and 95% confidence intervals will be computed.

    Measured: Up to 3.5 years

  3. PFS

    Will be estimated using the product-limit method of Kaplan and Meier; medians and 95% confidence intervals will be computed.

    Measured: Up to 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2016 (estimated)
  2. Study start17 Jan 2017
  3. Primary completionMar 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02935205
Sponsor's protocol ID
949968
Other IDs
UCDCC#267, UCDCC#267, P30CA093373, NCI-2016-01479
Status last verified
Nov 2023
First submitted
13 Oct 2016
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Enzalutamide and Indomethacin in people with Metastatic Prostate Carcinoma and Recurrent Prostate Carcinoma, run by Mamta Parikh at 1 site 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 21 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (time frame: Up to 3.5 years). The study lists 2 primary outcomes in all. 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 NCT02935205.

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 29 Nov 2023.

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