NUV-868 for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lawrence J. Ellison Institute for Transformative Medicine, Los Angeles, CAProstate Cancer+18 MoreNUV-868 - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial is testing a new drug, NUV-868, for safety and efficacy in patients with advanced solid tumors. The drug will be taken orally, either as a monotherapy or in combination with other drugs olaparib or enzalutamide, in 28-day cycles. The trial will continue until the disease progresses, there are unacceptable side effects, the patient withdraws consent, or the trial is terminated.

Eligible Conditions
  • Ovarian Cancer
  • Pancreatic Cancer
  • Prostate Cancer
  • Castration-resistant Prostate Cancer
  • Triple Negative Breast Cancer
  • Breast Cancer
  • Advanced Solid Tumors
  • Ovarian Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

10 Primary · 0 Secondary · Reporting Duration: Every 4 weeks throughout study treatment, up to an average of 12 months (end of treatment)

Day 28
Phase 1b Dose Escalation, NUV-868 + Olaparib: Pharmacokinetic (PK) profiles of NUV-868 and olaparib when administered in combination
Day 28
Phase 1b Dose Escalation, NUV-868 + Enzalutamide: Pharmacokinetic (PK) profiles of NUV-868 and enzalutamide when administered in combination
Day 28
Phase 1 Monotherapy Dose Escalation: Safety and tolerability of NUV-868 to determine the recommended Phase 2 dose (RP2D)
Phase 1b Dose Escalation, NUV-868 + Enzalutamide: Safety and tolerability of NUV-868 in combination with enzalutamide to determine the RP2cD
Phase 1b Dose Escalation, NUV-868 + Olaparib: Safety and tolerability of NUV-868 in combination with olaparib to determine the recommended Phase 2 combination dose (RP2cD)
Month 12
Phase 2 Monotherapy Expansion: Change from Baseline in Prostate-specific antigen (PSA) measurements
Phase 2b Combination Expansion, NUV-868 + Enzalutamide: Change from Baseline in PSA measurements
Phase 2b Combination Expansion, NUV-868 + Olaparib: Change from Baseline in PSA measurements
Month 12
Phase 2 Monotherapy Expansion: Change from Baseline in Tumor Imaging
Phase 2b Combination Expansion, NUV-868 + Olaparib: Change from Baseline in Tumor Imaging

Trial Safety

Safety Progress

1 of 3

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Trial Design

6 Treatment Groups

Phase 1 Monotherapy Dose Escalation
1 of 6
Phase 1b Dose Escalation: NUV-868 + Enzalutamide
1 of 6
Phase 2b Combination Expansion: NUV-868 + Enzalutamide
1 of 6
Phase 2 Monotherapy Expansion
1 of 6
Phase 1b Dose Escalation: NUV-868 + Olaparib
1 of 6
Phase 2b Combination Expansion: NUV-868 + Olaparib
1 of 6

Experimental Treatment

246 Total Participants · 6 Treatment Groups

Primary Treatment: NUV-868 · No Placebo Group · Phase 1 & 2

Phase 1 Monotherapy Dose Escalation
Drug
Experimental Group · 1 Intervention: NUV-868 · Intervention Types: Drug
Phase 1b Dose Escalation: NUV-868 + EnzalutamideExperimental Group · 2 Interventions: NUV-868, Enzalutamide · Intervention Types: Drug, Drug
Phase 2b Combination Expansion: NUV-868 + EnzalutamideExperimental Group · 2 Interventions: NUV-868, Enzalutamide · Intervention Types: Drug, Drug
Phase 2 Monotherapy Expansion
Drug
Experimental Group · 1 Intervention: NUV-868 · Intervention Types: Drug
Phase 1b Dose Escalation: NUV-868 + OlaparibExperimental Group · 2 Interventions: NUV-868, Olaparib · Intervention Types: Drug, Drug
Phase 2b Combination Expansion: NUV-868 + OlaparibExperimental Group · 2 Interventions: NUV-868, Olaparib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~2610
Olaparib
2017
Completed Phase 4
~1430

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: every 4 weeks throughout study treatment, up to an average of 12 months (end of treatment)

Who is running the clinical trial?

Nuvation Bio Inc.Lead Sponsor
3 Previous Clinical Trials
72 Total Patients Enrolled
2 Trials studying Prostate Cancer
72 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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Frequently Asked Questions

Are people still able to sign up for this experiment?

"That is accurate. The information available on clinicaltrials.gov demonstrates that this study, which was initially posted on 3/29/2022, is still recruiting participants. 246 individuals are needed for the trial taking place at 7 different locations." - Anonymous Online Contributor

Unverified Answer

Are there any other locations where this experiment is taking place?

"Currently, there are 7 sites enrolling patients for this trial. The locations of these centres include Baltimore, Detroit, Huntersville and other cities. To reduce the amount of travel required, make sure to select the centre nearest you when enrolling." - Anonymous Online Contributor

Unverified Answer

How many people are eligible to participate in this research project?

"In order to run the study, 246 people who meet the clinical trial's requirements must be recruited. The sponsor, Nuvation Bio Inc., will manage and operate the trial from different locations which include Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, Maryland as well as Karmanos Cancer Institute in Detroit, Michigan." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.