search
Back to results

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

Primary Purpose

Prostate Cancer, Prostatic Cancer, Cancer of Prostate

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NUV-422
Enzalutamide
Sponsored by
Nuvation Bio Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Phase 1, Phase 2, metastatic castration-resistant prostate cancer, NUV-422, enzalutamide, Xtandi, CDK, CDK inhibition, CDK2/4/6

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gabrail Cancer Center Research
  • Pennsylvania Cancer Specialists and Research Institute
  • NEXT Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Phase 1b Dose Escalation

Phase 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Phase 1b Dose Escalation: Safety and tolerability of NUV-422 in combination with enzalutamide to determine the recommended Phase 2 combination dose (RP2cD)
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), and laboratory abnormalities
Phase 2 Dose Expansion: Prostate-specific antigen (PSA)-response rate (PSA-RR)
PSA per standard criteria
Phase 2 Dose Expansion: Objective response rate (ORR)
ORR per standard criteria

Secondary Outcome Measures

Full Information

First Posted
December 22, 2021
Last Updated
August 2, 2022
Sponsor
Nuvation Bio Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05191017
Brief Title
Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC
Official Title
Phase 1b/2 Safety and Efficacy Study of NUV-422 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor decision
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nuvation Bio Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostatic Cancer, Cancer of Prostate, Cancer of the Prostate, Prostate Neoplasm, Castrate Resistant Prostate Cancer, Castration Resistant Prostatic Cancer, Castration Resistant Prostatic Neoplasms
Keywords
Phase 1, Phase 2, metastatic castration-resistant prostate cancer, NUV-422, enzalutamide, Xtandi, CDK, CDK inhibition, CDK2/4/6

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1b Dose Escalation
Arm Type
Experimental
Arm Description
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.
Arm Title
Phase 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
NUV-422
Intervention Description
NUV-422 is an investigational drug for oral dosing.
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Other Intervention Name(s)
Xtandi
Intervention Description
Enzalutamide
Primary Outcome Measure Information:
Title
Phase 1b Dose Escalation: Safety and tolerability of NUV-422 in combination with enzalutamide to determine the recommended Phase 2 combination dose (RP2cD)
Description
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), and laboratory abnormalities
Time Frame
During the DLT period (28 days)
Title
Phase 2 Dose Expansion: Prostate-specific antigen (PSA)-response rate (PSA-RR)
Description
PSA per standard criteria
Time Frame
Every 4 weeks throughout study treatment, an average of 6 months
Title
Phase 2 Dose Expansion: Objective response rate (ORR)
Description
ORR per standard criteria
Time Frame
Every 8 weeks throughout study treatment, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of metastatic castration-resistant prostate cancer with disease progression despite castrate levels of testosterone Have radiographic or biochemical evidence of progression as determined by Investigator per standard criteria Have no known active or symptomatic central nervous system (CNS) disease 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 Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2 Adequate bone marrow and organ function Eligible to receive enzalutamide Life expectancy of > 6 months Exclusion Criteria: History of seizure or any condition that may predispose to seizure (prior cortical stroke or significant brain trauma) 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 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 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 Prior therapy with enzalutamide, apalutamide, darolutamide, or investigational androgen receptor inhibitors Known allergy or hypersensitivity to enzalutamide
Facility Information:
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Pennsylvania Cancer Specialists and Research Institute
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
NEXT Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs