A Study of CC-90011 and Comparators in Participants With Prostate Cancer

NCT04628988 | Completed Phase 1 FDA Drug

• 2 other identifiers: CC-90011-PCA-001U1111-1257-9342
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, positron emission tomography (PET) imaging Proof of Biology (POB) study to determine whether CC -90011 reverses, by the induction of androgen receptor (AR) expression, the castration resistance, due to lineage switch, in participants with mCRPC that have failed enzalutamide as last prior therapy. This study aims to assess whether CC-90011 can induce AR expression and, consequently, re-sensitize tumors to anti-hormonal therapy.

Conditions

Prostatic Neoplasms

Keywords

mCRPC; AR; enzalutamide; abiraterone; LSD1; Prostate Cancer; CC-90011; Prednisone

Outcome Measures

Primary Outcomes (1)

• Assessment of androgen receptor (AR) level

  FDG/FDHT PET imaging will be compared with Screening to Cycle 1 (each cycle is 28 days) and from Cycle 1 to Cycle 3 (Cycle 2-3 is combined therapy period) to assess changes in AR expression.

  From Screening to the end of cycle 3 (each cycle is 28 days)

Secondary Outcomes (3)

• Safety and tolerability assessed by Adverse events (AEs)

  From the time the subject signs the ICF until 90 days (± 3 days) after the last dose of study medication

• Safety and tolerability assessed by dose-limiting toxicities (DLTs)

  Through study completion, Up to 1.5 years

• Assessment of anti-tumor activity

  Through study completion, Up to 3 years

Study Arms (1)

CC-90011 in combination with Abiraterone and Prednisone

EXPERIMENTAL

Oral administration (PO) of CC-90011 monotherapy administered once per week (QW), for 4 weeks. From cycle 2 onwards, all participants will receive 60 mg of CC-90011 PO QW, in combination with 100 mg of abiraterone PO daily, and 5 mg of prednisone PO every 12 hours (10mg QD)

Drug: CC-90011; Drug: Abiraterone; Drug: Prednisone

Interventions

CC-90011 DRUG

Capsule

CC-90011 in combination with Abiraterone and Prednisone

Abiraterone DRUG

Tablet

Also known as: Zytiga

CC-90011 in combination with Abiraterone and Prednisone

Prednisone DRUG

Tablet

Also known as: Deltasone

CC-90011 in combination with Abiraterone and Prednisone

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is a male ≥ 18 years of age the time of signing the informed consent form (ICF).
• Histologically confirmed adenocarcinoma of the prostate.
• Surgically or medically castrated, with testosterone levels of \< 50 ng/dL (\<2.0 nM). If the participant is being treated with luteinizing hormone-releasing hormone (LHRH) agonists/antagonists (participant who have not undergone orchiectomy) this therapy must have been initiated at least 4 weeks prior to Cycle 1 Day 1 and must be continued throughout the study.
• Participants must have failed prior therapy with enzalutamide or apalutamide
• Has completed at least 12 weeks of prior continuous therapy with enzalutamide or apalutamide .
• Has been without enzalutamide, or apalutamide treatment for \>30 days prior to initiation of study treatment.
• Documented prostate cancer progression as assessed by the investigator with one of the following:
• Prostate-specific antigen (PSA) progression defined by a minimum of 3 rising PSA levels with an interval of ≥1 week between each determination. The PSA value at screening must be ≥1 µg/L (1 ng/mL) if PSA is the only indication of progression; participants on systemic glucorticoids for control of symptoms must have documented PSA progression by PCWG3 criteria while on systemic glucocorticoids prior to commencing Cycle 1 Day 1 treatment.
• Radiographic progression of soft tissue disease by RECIST 1.1 or bone metastasis with 2 or more documented new bone lesions on a bone scan with or without PSA progression.
• Participants must have FDHT lesion \>2 cm lesion that has an SUVmax of 2.9 or less in bone, or 2.4 or less in soft tissue, or two or more smaller lesions that meet those criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening.
• Participants must have the following laboratory values:
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L without growth factor support for 7 days (14 days if participant received pegfilgastrim)
• Hemoglobin (Hgb) ≥ 9 g/dL (≥ 90 g/L or \> 5.59 mmol/L)
• Platelet count (plt) ≥ 100 x 109/L

You may not qualify if:

• Participant has received anti-cancer therapy (either approved or investigational) \< 4 weeks or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1.
• \- \< 42 days for prior nitrosureas or mitomycin C
• Toxicities resulting from prior systemic cancer therapies must have resolved to ≤ NCI CTCAE Grade 1 prior to starting CC-90011 treatment (with exception of Grade 2 peripheral neuropathy and alopecia).
• Previous anaphylactic reaction to either FDHT or FDG.
• Participant has undergone major surgery ≤ 4 weeks or minor surgery ≤ 2 weeks prior to Cycle 1 Day 1 or who have not recovered from surgery.
• Participant has completed any radiation treatment \< 4 weeks prior to Cycle 1 Day 1 or \< 2 weeks for palliative bone radiotherapy (single fraction). Participants with \> 25% of myelopoietic bone marrow radiation are not allowed to be enrolled on this study.
• Participant has persistent diarrhea due to a malabsorptive syndrome (such as celiac sprue or inflammatory bowel disease) ≥ NCI CTCAE Grade 2, despite medical management), or any other significant GI disorder that could affect the absorption of CC-90011.
• Participant with symptomatic or uncontrolled ulcers (gastric or duodenal), particularly those with a history of and/or risk of perforation and GI tract hemorrhages.
• Participant with any hemorrhage/bleeding event \> CTCAE Grade 2 or haemoptysis \> 1 teaspoon within 4 weeks prior to the first dose
• Symptomatic and untreated or unstable central nervous system (CNS) metastases or clinically significant spinal cord compression.
• Participant recently treated with whole brain radiation or stereotactic radiosurgery for CNS metastases must have completed therapy at least 4 weeks prior to Cycle 1, Day 1 and have a follow-up brain computed tomography (CT) or magnetic resonance imaging (MRI) demonstrating either stable or improving metastases 4 or more weeks after completion of radiotherapy (the latter to be obtained as part of the Screening Assessments, refer to Section 6.1)
• Participant must be asymptomatic and off steroids or on stable dose of steroids for at least 4 weeks (?10 mg/day prednisone equivalent)
• Participant has known symptomatic acute or chronic pancreatitis.
• Participant with severe hepatic impairment (Child-Pugh Class C).
• Medical castration with LHRH analogue is not permitted at any time during treatment with abiraterone and prednisone if not started at least 4 weeks prior to Cycle 2 Day 1.

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Local Institution - 101

New York, New York, 10021, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

pulrodemstat besilate; abiraterone; Abiraterone Acetate; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 16, 2020
• Study Start: July 28, 2021
• Primary Completion: May 26, 2023
• Study Completion: May 26, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (1)