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Prostate CancerPhase 1NCT02833883

Use of an Experimental Drug, CC-115, With Enzalutamide in Men With Castration-Resistant Prostate Cancer

A Phase 1 study testing Enzalutamide and CC-115 in people with Prostate Cancer and Castration Resistant Prostate Cancer, run by Memorial Sloan Kettering Cancer Center 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 main purpose of this study to define the good and/or bad effects of the combination of enzalutamide and CC-115 in patients with castration-resistant prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Enzalutamide and CC-115
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
5 sitesUnited States
Study dates
Jul 2016to 13 Jan 2023
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

  • Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.
  • NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
  • Males 18 years of age and above with a life expectancy of at least 6 months.
  • Histological or cytological proof of prostate cancer
  • Willing to provide a tumor sample via biopsy from a metastatic site of disease to be collected at screening if safe and feasible per treating investigator discretion. Adequate archival tissue can be used if available in lieu of baseline biopsy.
  • Documented progressive metastatic CRPC based on at least one of the following criteria:
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  • Rise in PSA: a minimum of 3 rising levels, with an interval of at least 1 week between each determination. The last determination must have a value ≥1 ng/mL, obtained within 4 weeks of starting study drug
  • Measurable disease: new or progressive soft tissue disease on computerized tomography (CT) or magnetic resonance imaging
  • Radionuclide bone scan: at least 2 new bone lesions, as defined by the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria33
  • Serum testosterone < 50 ng/dL. Patients must continue primary androgen deprivation with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy
  • ECOG performance status of 0-1
  • Finasteride, bicalutamide and nilutamide discontinued at least 4 weeks prior to registration.
  • Physiologic doses of corticosteroids are permitted (i.e., no more than 10mg of prednisone daily).
  • At least 4 weeks must have elapsed from the use of palliative radiation, Strontium-89, Radium-223, or approved immunotherapy prior to registration.
  • Less than or equal to 5 half lives or 4 weeks, whichever is shorter, from the use of any investigational therapy prior to registration.
  • Normal organ function with acceptable initial laboratory values within 14 days of registration.
  • ANC ≥ 1,500/μl
  • Hemoglobin ≥ 9g/dL
  • Platelet count ≥ 100,000/μl
  • Creatinine ≤ 1.5 x the institutional upper limit of normal (ULN), or 24-hr clearance ≥50 mL/min
  • Potassium ≥ 3.5 mmol/L (within institutional normal range, or correctable with supplements)
  • Bilirubin ≤ 1.5 x ULN (unless documented Gilbert's disease)
  • SGOT (AST) ≤ 2.5 x ULN
  • SGPT (ALT) ≤ 2.5 x ULN
  • Glycated hemoglobin (HbA1c < 6.4%
  • Able to take oral medication without crushing, dissolving or chewing tablets.
  • Able to adhere to the study visit schedule and other protocol requirements.

Who cannot join

  • Prior exposure to enzalutamide, ARN-509, or other investigational AR-directed therapy
  • Prior exposure to abiraterone acetate, ketoconazole or other specific CYP-17 inhibitors
  • Prior exposure to agents specifically targeting both mTOR complexes (dual TORC1+TORC2 inhibitors) and/or PI3K/AKT pathways
  • Prior chemotherapy for castration resistant disease. Chemotherapy given in the castration-sensitive setting is permissible. At least 6 months from registration must have elapsed since chemotherapy was last received.
  • Symptomatic central nervous system metastases
  • Known history of acute or chronic pancreatitis
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  • Persistent diarrhea or malabsorption ≥ NCI CTCAE Grade 2, despite medical management
  • Clinically significant cardiac diseases, including any of the following:
  • Unstable angina pectoris
  • Myocardial infarction ≤ 3 months prior to registration
  • Other clinically significant heart disease such as congestive heart failure requiring treatment or uncontrolled hypertension
  • Uncontrolled diabetes mellitus
  • Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
  • Major surgery ≤ 2 weeks prior to registration or who have not recovered from side effects of such therapy. Subjects must have recovered from any effects of recent radiotherapy that might confound the safety evaluation of study drug.
  • Hematopoietic stem cell transplant ≤ 3 months prior to registration.
  • Adults of reproductive potential not employing two forms of birth control:
  • Males having partners who are female with child-bearing potential must agree that they and/or their partners will use at least two effective contraceptive methods (including one barrier method) when engaging in reproductive sexual activity throughout the study from the time of informed consent, and will avoid conceiving for 28 days after the last dose of CC-115.
  • Known human immunodeficiency virus (HIV) infection
  • Known chronic hepatitis B or C virus (HBV/HCV) infection
  • Concurrent active second malignancy for which the subject is receiving therapy, other than non-melanomatous skin cancer or superficial transitional cell carcinoma.
  • History of seizure or any condition that may predispose to seizure including, but not limited to, underlying brain injury, stroke in the past 6 months, primary brain tumors, brain metastases
  • Active treatment with medications that lower the seizure threshold which cannot be held:
  • Aminophylline/theophylline;
  • Atypical antipsychotics (e.g., clozapine, olanzapine, risperidone, ziprasidone);
  • Bupropion;
  • Lithium;
  • Pethidine;
  • Phenothiazine antipsychotics (e.g., chlorpromazine, mesoridazine, thioridazine);
  • Tricyclic and tetracyclic antidepressants (e.g., amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine).
  • Any other condition which, in the opinion of the Investigator, would preclude participation in this trial

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • John Hopkins Medical Center

    Baltimore, Maryland, 21287

  • Duke University Medical Center

    Durham, North Carolina, 27701

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of California San Francisco

    San Francisco, California, 94143

  • University of Washington School of Medicine

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: A Phase 1b Study of Enzalutamide Plus CC-115 in Men With Castration-Resistant Prostate Cancer (CRPC)

The main purpose of this study to define the good and/or bad effects of the combination of enzalutamide and CC-115 in patients with castration-resistant prostate cancer.

Being tested
Enzalutamide, CC-115
Keywords
Enzalutamide, CC-115, 16-074
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 NCT02833883
Study groupRoleWhat they receive
Enzalutamide plus CC-115ExperimentalThe first several study participants will receive the lowest dose. If the drug does not cause serious side effects, it will be given to other study participants at a higher dose. The doses will continue to increase for every group of study participants until the maximum tolerated dose is identified. Participants at each site will participate in the dose escalation phase of the study. During the dose escalation phase, study participants will be assigned sequentially to three dose levels in groups (cohorts) of 3 to 6 subjects per dose level: Cohort 1: CC-115 at 5 mg dose twice a day \& enzalutamide at 160 mg once a day. Cohort 2: CC-115 at 10 mg dose twice a day \& enzalutamide at 160 mg once a day. The protocol has been amended to accrue an additional in the expansion phase treated at 7.5 mg BID. Amended to treat expansion group with 5mg BID of CC-115.
Receives: Drug: Enzalutamide; Drug: CC-115

What is being measured

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

  1. establish the maximum tolerated dose (MTD)

    Subjects will be treated in cohorts of size three and six and the dosage will be escalated if the clinical toxicity is acceptable. The maximum tolerated dose is defined as the highest dose level with an observed incidence of DLT in no more than one out of six subjects treated at a particular dose level. A DLT will be determined by cycle 1 toxicity, although all-cycle toxicity will be recorded.

    Measured: 1 year

Timeline

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

  1. First posted14 Jul 2016 (estimated)
  2. Study startJul 2016
  3. Primary completion13 Jan 2023
  4. Study completion13 Jan 2023

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02833883
Sponsor's protocol ID
16-074
Other IDs
c15-160
Status last verified
Jan 2023
First submitted
12 Jul 2016
Last updated
19 Jan 2023
Results posted
No

Publications

  • Zhao JL, Antonarakis ES, Cheng HH, George DJ, Aggarwal R, Riedel E, Sumiyoshi T, Schonhoft JD, Anderson A, Mao N, Haywood S, Decker B, Curley T, Abida W, Feng FY, Knudsen K, Carver B, Lacouture ME, Wyatt AW, Rathkopf D. Phase 1b study of enzalutamide plus CC-115, a dual mTORC1/2 and DNA-PK inhibitor, in men with metastatic castration-resistant prostate cancer (mCRPC). Br J Cancer. 2024 Jan;130(1):53-62. doi: 10.1038/s41416-023-02487-5. Epub 2023 Nov 18.

    PubMed 37980367

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Enzalutamide and CC-115 in people with Prostate Cancer and Castration Resistant Prostate Cancer, run by Memorial Sloan Kettering Cancer Center 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 27 inclusion and 30 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 19 Jan 2023. 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?

establish the maximum tolerated dose (MTD) (time frame: 1 year). 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 NCT02833883, 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 19 Jan 2023.

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