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Prostate CancerPhase 1NCT02125084

Enzalutamide Plus Everolimus in Men With Metastatic Castrate-Resistant Prostate Cancer

A Phase 1 study testing Everolimus and Enzalutamide in people with Prostate Cancer, run by SCRI Development Innovations, LLC at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the safety and efficacy of a novel combination of agents, enzalutamide and everolimus, for the treatment of patients with metastatic castrate-resistant prostate cancer who have never received prior chemotherapy, or who have previously received docetaxel chemotherapy and have… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Everolimus and Enzalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
5 sitesUnited States
Study dates
Oct 2014to 3 May 2021
Phase
Phase 1
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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • KEY POINTS:
  • Adenocarcinoma of the prostate confirmed histologically.
  • Metastatic disease confirmed by biopsy or imaging studies.
  • Castrate-resistant prostate cancer (i.e., progression of prostate cancer while receiving standard androgen ablation therapy, orchiectomy or luteinizing hormone-releasing hormone [LHRH] antagonist). Castrate levels of serum testosterone must be documented at progression in patients who have not had an orchiectomy.
  • Chemotherapy-naive or previously treated with docetaxel for metastatic prostate cancer.
  • ECOG of 0 to 2.
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  • Patients must have progressive metastatic prostate cancer by at least 1 of the following criteria:
  • Progression of measurable lesions defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Bone progression defined by 2 or more new lesions on bone scan.
  • PSA progression is determined by a minimum of two rising PSA levels with an interval of 1 week or greater between each determination. The screening PSA measurement (documenting progression) must be greater than or equal to 2 ng/mL.
  • Adequate hematologic, hepatic and renal function.
  • Adequate coagulation parameters and serum chemistries.
  • Ability to swallow and retain oral medication.
  • Life expectancy of 6 months or greater.
  • Ability to understand the nature of the study and give written informed consent.

Who cannot join

  • Treatment with more than 2 prior chemotherapy regimens.
  • Previous treatment with enzalutamide or other investigational androgen receptor inhibitors.
  • Previous treatment with PI3K/mTOR inhibitors.
  • Known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or its excipients.
  • Use of an investigational drug within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug. For investigational drugs for which 5 half-lives is less than 21 days, a minimum of 10 days between termination of the investigational drug and administration of study drug is required.
  • Most recent chemotherapy ≤21 days from first dose of study treatment and/or patient did not recover from most recent chemotherapy side effects prior to study entry.
  • CNS metastases.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Tennessee Oncology

    Chattanooga, Tennessee, 37404

  • Oncology Hematology Care Inc.

    Cincinnati, Ohio, 45242

  • Florida Cancer Specialists

    Fort Myers, Florida, 33916

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203

  • Florida Cancer Center

    St. Petersburg, Florida, 33705

Other trials in United States

About this study

Official title: Enzalutamide Plus Everolimus in Men With Metastatic Castrate-Resistant Prostate Cancer: A Phase I Study With a Maximum Tolerated Dose Expansion Cohort

The purpose of this study is to determine the safety and efficacy of a novel combination of agents, enzalutamide and everolimus, for the treatment of patients with metastatic castrate-resistant prostate cancer who have never received prior chemotherapy, or who have previously received docetaxel chemotherapy and have progressive disease.

Read the detailed description

This is a multi-center, open-label, Phase I study with an expansion cohort, in patients with metastatic Castrate-Resistant Prostate Cancer (CRPC) who are chemotherapy-naive or have previously received docetaxel chemotherapy and have progressive disease at the time of study entry. The dose escalation phase of this study will establish the optimum daily dose of everolimus that can be delivered along with a standard daily dose of enzalutamide to patients with metastatic CRPC. Eligible patients must have evaluable (elevated PSA) or measurable disease (per RECIST v1.1). Following completion of the dose escalation phase, an additional cohort of patients will be treated at the maximum tolerated dose (MTD) to give preliminary information regarding the efficacy of this combination.

Conditions
Prostate Cancer
Keywords
Metastatic Prostate Cancer, Castrate-resistant, Enzalutamide, Everolimus
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02125084
Study groupRoleWhat they receive
Everolimus and EnzalutamideExperimentalDose Escalation Phase (18 patients): 3-6 patients will be treated at each dose level until the Maximum Tolerated Dose (MTD) is determined. * Everolimus: Orally (PO) once daily (dose to be determined; * Enzalutamide: 160mg (four 40mg capsules) PO continuous daily dosing. Dose Expansion Phase (23 patients): Everolimus and Enzalutamide to be administered using the MTD determined in the dose escalation phase.
Receives: Drug: Everolimus; Drug: Enzalutamide

What is being measured

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

  1. Maximum Tolerated Dose (MTD) of everolimus plus enzalutamide.

    MTD will be determined by testing increasing doses of everolimus with standard dose enzalutamide in 3-patient dose escalation cohorts. The MTD is defined as the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity (DLT) during 1 cycle (28 days) of therapy, assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

    Measured: 6-8 months

  2. Prostate-specific antigen (PSA) response rate

    PSA response will be measured by the percent decreased from the reported baseline value. The proportion of patients with documented PSA decreases of 50% and 85% in PSA levels will be reported separately.

    Measured: every 8 weeks for up to 24 months

  3. Number of patients with serious and non-serious adverse events.

    Evaluate the safety of the combination per CTCAE v4.0, every 4 weeks from date of first study treatment until the date of documented progression, up to 24 months.

    Measured: every 4 weeks up to 24 months

  4. Pharmacokinetic sampling for everolimus

    Levels of everolimus in blood samples will be collected from patients at selected timepoints prior to dosing during the first 3 cycles of treatment.

    Measured: Cycle 1, Day 1: prior to initial dose and 2hrs post-dose; Cycles 2 and 3, Day 1: prior to initial dose

Secondary outcomes (3)

  1. Time to PSA progression

    Defined as the time from date of first protocol treatment until date of PSA progression. PSA progression is defined as when patient has both a ≥25% increase above the nadir or baseline value and when the absolute increase is ≥2ng/mL.

    Measured: every 8 weeks up to 24 months

  2. Overall Response Rate (ORR)

    Soft tissue response rate [percentage of complete responders (CR) and partial responders (PR) per RECIST v1.1]

    Measured: every 8 weeks up to 24 months

  3. Progression-free survival (PFS)

    Restaging will occur every 8 weeks from date of first treatment until date of first progression, or date of death from any cause, whichever comes first - up to 24 months.

    Measured: every 8 weeks up to 24 months

Timeline

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

  1. First posted29 Apr 2014 (estimated)
  2. Study startOct 2014
  3. Primary completion3 May 2021
  4. Study completion3 May 2021

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02125084
Sponsor's protocol ID
SCRI GU 99
Status last verified
May 2021
First submitted
17 Apr 2014
Last updated
4 May 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Everolimus and Enzalutamide in people with Prostate Cancer, run by SCRI Development Innovations, LLC at 5 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 15 inclusion and 7 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: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum Tolerated Dose (MTD) of everolimus plus enzalutamide. (time frame: 6-8 months). The study lists 4 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 NCT02125084.

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 4 May 2021.

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