NUV-868 + Olaparib/Enzalutamide for Cancer
Trial Summary
What is the purpose of this trial?
This trial tests a new drug, NUV-868, taken regularly by mouth, in patients with advanced cancers. It aims to find the best dose and see if combining it with other drugs can improve treatment. The study includes patients with advanced solid tumors and a specific type of prostate cancer.
Will I have to stop taking my current medications?
The trial requires that you stop taking chemotherapy, hormonal therapy (except certain ongoing treatments), radiation, or biological anticancer therapy at least 14 days before starting the study medication. Additionally, you cannot take medications that strongly affect certain liver enzymes (CYP3A4/5) while participating in the trial.
Will I have to stop taking my current medications?
The trial requires that you stop taking chemotherapy, hormonal therapy (except certain ongoing treatments), radiation, or biological anticancer therapy at least 14 days before starting the study drug. Additionally, you cannot take medications that strongly affect certain liver enzymes (CYP3A4/5).
What data supports the effectiveness of the drug combination NUV-868 + Olaparib/Enzalutamide for cancer?
Research shows that Olaparib, when used alone, significantly improves survival in patients with certain genetic changes and advanced prostate cancer. Enzalutamide has also been effective in treating advanced prostate cancer, and combining it with other treatments has shown promise in overcoming resistance in preclinical models.12345
What data supports the effectiveness of the drug combination NUV-868 + Olaparib/Enzalutamide for cancer?
Research shows that Olaparib, when used alone, significantly improves survival in patients with certain genetic changes in prostate cancer. Additionally, Enzalutamide has proven effective in treating advanced prostate cancer, and combining it with other drugs has shown promise in overcoming resistance in preclinical models.12345
Is the combination of NUV-868, Olaparib, and Enzalutamide safe for humans?
Enzalutamide has been studied for safety in prostate cancer patients, showing some risks like seizures, high blood pressure, and falls. Olaparib has been used in prostate cancer treatment, but specific safety details are not provided in the available research. No specific safety data for NUV-868 is mentioned in the research provided.56789
What safety information is available for Enzalutamide and Olaparib in cancer treatment?
What makes the drug NUV-868 combined with Olaparib or Enzalutamide unique for cancer treatment?
NUV-868 combined with Olaparib or Enzalutamide is unique because it targets specific pathways in cancer cells, potentially overcoming resistance to existing treatments like enzalutamide. This combination may offer a new approach for patients with advanced prostate cancer who have not responded to other therapies.134510
What makes the drug NUV-868 combined with Olaparib or Enzalutamide unique for cancer treatment?
NUV-868 combined with Olaparib or Enzalutamide is unique because it targets specific pathways involved in cancer progression, potentially offering a new approach for patients who have developed resistance to existing treatments like enzalutamide. This combination may enhance the effectiveness of current therapies by addressing different mechanisms of cancer cell survival.134510
Eligibility Criteria
Adults with advanced solid tumors like ovarian, pancreatic, prostate, or breast cancer who have recovered from previous cancer therapy side effects and have good bone marrow and organ function. They must not be pregnant or breastfeeding, haven't had certain treatments recently, and can't have active brain disease.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Monotherapy
NUV-868 is administered at escalating dose levels until the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) is determined
Phase 1b Combination
NUV-868 is administered in combination with olaparib or enzalutamide to determine the recommended Phase 2 combination dose (RP2cD)
Phase 2 Combination
NUV-868 is administered at the RP2cD in combination with olaparib or enzalutamide to assess safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Enzalutamide
- NUV-868
- Olaparib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nuvation Bio Inc.
Lead Sponsor