What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, such as paclitaxel, cisplatin, and olaparib, have several known side effects. Paclitaxel can cause peripheral neuropathy, hair loss, and myelosuppression, leading to increased risk of infection, anemia, and bleeding. Cisplatin is associated with nephrotoxicity, ototoxicity, and severe nausea and vomiting. Olaparib, a PARP inhibitor, can cause fatigue, nausea, anemia, and other hematologic toxicities. These side effects can significantly impact the patient's quality of life and require careful management.

What prior FDA approvals exist?

The FDA has approved several treatments for ovarian cancer, particularly focusing on targeted therapies and combination regimens. Olaparib, a PARP inhibitor, has been approved for maintenance therapy in patients with BRCA-mutated ovarian cancer following a response to platinum-based chemotherapy. Other PARP inhibitors like niraparib and rucaparib have also received FDA approval for similar indications. Bevacizumab, an angiogenesis inhibitor, is approved in combination with chemotherapy for the treatment of advanced ovarian cancer. These treatments aim to exploit specific vulnerabilities in cancer cells, similar to the potential anti-tumor effects being studied with NUV-868 in combination with olaparib or enzalutamide.

What other types of research exist?

Promising novel alternatives to NUV-868 for ovarian cancer patients include: 1) M3814 in combination with PLD, which has shown enhanced activity over PLD alone. 2) STK899704, a tubulin inhibitor with efficacy comparable to 5-fluorouracil. 3) Combination treatment with cisplatin and olaparib, which has demonstrated synergistic effects and dose reduction potential. 4) SQ1274, a microtubule inhibitor with a lower IC50 than paclitaxel in ovarian cancer cell lines.

← Back to Search

Other

NUV-868 + Olaparib/Enzalutamide for Cancer

Q: What is the mechanism of action of this treatment?

Common treatments for ovarian cancer include chemotherapy, targeted therapy, and investigational treatments like those in the NUV-868 trial. Chemotherapy drugs, such as paclitaxel and carboplatin, kill cancer cells by damaging their DNA. Targeted therapies, like PARP inhibitors (e.g., olaparib), are particularly effective in patients with BRCA mutations as they block the cancer cells' ability to repair DNA, leading to cell death. NUV-868, combined with olaparib, is being studied for its potential to enhance anti-tumor effects by inhibiting specific survival pathways in cancer cells. Understanding these mechanisms helps in tailoring treatments to the cancer's genetic profile, improving efficacy and outcomes for patients.

Phase 1 & 2

Recruiting

Research Sponsored by Nuvation Bio Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with advanced solid tumors that have progressed during or after treatment with approved therapies or for which there is no standard effective therapy available (Phase 1)

Have no known active or symptomatic central nervous system (CNS) disease

Must not have

Received treatment with an investigational agent for any indication within 14 days for non-myelosuppressive agent, or within 21 days or < 5 half-lives (whichever is longer) for myelosuppressive agent, prior to the first dose of study treatment

Female patients who are pregnant of breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 8 weeks during the first 24 weeks and then every 12 weeks, up to an average of 12 months (end of treatment)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

NUV-868 is being tested alone and combined with Olaparib or Enzalutamide in patients with advanced solid tumors to find safe doses (Phase 1/1b) and test effectiveness (Phase 2). Patients take NUV-868 orally daily for 28-day cycles until they no longer benefit.

What are the potential side effects?

Potential side effects of NUV-868, Olaparib, or Enzalutamide may include reactions related to the immune system's response to the drugs, gastrointestinal issues due to oral administration, fatigue from treatment regimens, as well as possible impacts on liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My advanced cancer has worsened despite treatment, or there's no effective treatment for it.

Select...

I do not have any active brain or spinal cord diseases.

Select...

I do not have any active brain or spinal cord diseases.

Select...

I can perform all self-care but may not be able to work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I haven't taken experimental drugs recently.

Select...

I am currently pregnant or breastfeeding.

Select...

I need medication that strongly affects certain liver enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 8 weeks during the first 24 weeks and then every 12 weeks, up to an average of 12 months (end of treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 8 weeks during the first 24 weeks and then every 12 weeks, up to an average of 12 months (end of treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks during the first 24 weeks and then every 12 weeks, up to an average of 12 months (end of treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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: Pharmacokinetic (PK) profiles of NUV-868 and enzalutamide when administered in combination

Phase 1b Dose Escalation, NUV-868 + Enzalutamide: Safety and tolerability of NUV-868 in combination with enzalutamide to determine the RP2cD

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Active Control

Group I: Phase 2: NUV-868 MonotherapyExperimental Treatment1 Intervention

NUV-868 will be administered at the RP2D in one arm of a randomized Phase 2 combination (NUV-868 + enzalutamide) cohort.

Group II: Phase 2 Combination: NUV-868 + OlaparibExperimental Treatment2 Interventions

NUV-868 will be administered at the RP2cD. Olaparib will be administered at the RP2cD.

Group III: Phase 2 Combination: NUV-868 + EnzalutamideExperimental Treatment2 Interventions

NUV-868 will be administered at the RP2cD. Enzalutamide will be administered at the RP2cD.

Group IV: Phase 1b Combination: NUV-868 + OlaparibExperimental Treatment2 Interventions

NUV-868 will be administered at escalating dose levels in combination with olaparib until the recommended Phase 2 combination dose (RP2cD) is determined. 300 mg olaparib will be administered orally twice daily throughout the 28-day cycles of NUV-868.

Group V: Phase 1b Combination: NUV-868 + EnzalutamideExperimental Treatment2 Interventions

NUV-868 will be administered daily at escalating dose levels in combination with enzalutamide until the RP2cD is determined. 160 mg enzalutamide will be administered orally daily throughout the 28-day cycles of NUV-868.

Group VI: Phase 1 MonotherapyExperimental Treatment1 Intervention

NUV-868 will be administered at escalating dose levels until the maximum tolerated dose (MTD) is reached or a recommended Phase 2 dose (RP2D) is determined.

Group VII: Phase 2: Enzalutamide MonotherapyActive Control1 Intervention

160 mg enzalutamide will be administered orally daily in one arm of a randomized Phase 2 combination (NUV-868 + enzalutamide) cohort.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

2007

Completed Phase 4

~2190

Enzalutamide

2014

Completed Phase 4

~3820

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ovarian cancer include chemotherapy, targeted therapy, and investigational treatments like those in the NUV-868 trial. Chemotherapy drugs, such as paclitaxel and carboplatin, kill cancer cells by damaging their DNA. Targeted therapies, like PARP inhibitors (e.g., olaparib), are particularly effective in patients with BRCA mutations as they block the cancer cells' ability to repair DNA, leading to cell death. NUV-868, combined with olaparib, is being studied for its potential to enhance anti-tumor effects by inhibiting specific survival pathways in cancer cells. Understanding these mechanisms helps in tailoring treatments to the cancer's genetic profile, improving efficacy and outcomes for patients.