Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC

August 2, 2022 updated by: Nuvation Bio Inc.

Phase 1b/2 Safety and Efficacy Study of NUV-422 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NUV-422-04 is an open-label Phase 1b/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with enzalutamide. The study population is comprised of adults with mCRPC. Patients will self-administer NUV-422 and 160 mg enzalutamide orally in 28-day cycles. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center Research
    • Pennsylvania
      • Gettysburg, Pennsylvania, United States, 17325
        • Pennsylvania Cancer Specialists and Research Institute
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • NEXT Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis of metastatic castration-resistant prostate cancer with disease progression despite castrate levels of testosterone
  2. Have radiographic or biochemical evidence of progression as determined by Investigator per standard criteria
  3. Have no known active or symptomatic central nervous system (CNS) disease

  4. Prior therapy with abiraterone required and:

    • For Phase 1b only: up to 2 prior taxane-based chemotherapy regimens allowed for castration-resistant disease
    • For Phase 2 only: Patients must not have received prior taxane-based chemotherapy for castrate-resistant disease or prior treatment with CDK inhibitors
  5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
  6. Adequate bone marrow and organ function
  7. Eligible to receive enzalutamide
  8. Life expectancy of > 6 months

Exclusion Criteria:

  1. History of seizure or any condition that may predispose to seizure (prior cortical stroke or significant brain trauma)
  2. Have received chemotherapy, hormonal therapy (with the exception of ongoing LHRH analogs) radiation, or biological anti-cancer therapy within 14 days prior to first dose of NUV-422 and enzalutamide
  3. Received treatment with an investigational agent for any indication within 14 days for non-myelosuppressive agent or 21 days (or < 5 half-lives) for myelosuppressive agent prior to the first dose of NUV-422 and enzalutamide

  4. Requires medications that are known to be strong inducers and /or inhibitors of CYP3A4/5 enzymes, except enzalutamide

    • For Phase 1b only: Requires medications that are known to be moderate inducers and /or inhibitors of CYP3A4/5 enzymes, except enzalutamide
  5. Prior therapy with enzalutamide, apalutamide, darolutamide, or investigational androgen receptor inhibitors
  6. Known allergy or hypersensitivity to enzalutamide

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1b Dose Escalation

NUV-422 will be administered orally at escalating dose levels in combination with enzalutamide until the recommended Phase 2 combination dose (RP2cD) is determined.

160 mg enzalutamide will be administered orally daily throughout the 28-day cycles of NUV-422.
Drug: NUV-422
NUV-422 is an investigational drug for oral dosing.
Drug: Enzalutamide
Enzalutamide
Other Names:
  • Xtandi
Experimental: Phase 2

NUV-422 will be administered orally at the RP2cD in combination with enzalutamide.

160 mg enzalutamide will be administered orally daily throughout the 28-day cycles of NUV-422.
Drug: NUV-422
NUV-422 is an investigational drug for oral dosing.
Drug: Enzalutamide
Enzalutamide
Other Names:
  • Xtandi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1b Dose Escalation: Safety and tolerability of NUV-422 in combination with enzalutamide to determine the recommended Phase 2 combination dose (RP2cD)
Time Frame: During the DLT period (28 days)
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), and laboratory abnormalities
During the DLT period (28 days)
Phase 2 Dose Expansion: Prostate-specific antigen (PSA)-response rate (PSA-RR)
Time Frame: Every 4 weeks throughout study treatment, an average of 6 months
PSA per standard criteria
Every 4 weeks throughout study treatment, an average of 6 months
Phase 2 Dose Expansion: Objective response rate (ORR)
Time Frame: Every 8 weeks throughout study treatment, an average of 6 months
ORR per standard criteria
Every 8 weeks throughout study treatment, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nuvation Bio Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

July 1, 2026

Study Registration Dates

First Submitted

December 22, 2021

First Submitted That Met QC Criteria

January 12, 2022

First Posted (Actual)

January 13, 2022

Study Record Updates

Last Update Posted (Actual)

August 5, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUV-422-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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