Antroquinonol for Metastatic Pancreatic Cancer

Recruiting at 8 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Golden Biotechnology Corporation

Must not be taking: CYP inhibitors/inducers

Disqualifiers: Other malignancies, Serious infections, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

52 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, antroquinonol, combined with standard chemotherapy drugs to treat advanced pancreatic cancer. It aims to find the safest dose and see how well the combination works. The study focuses on patients who haven't been treated before for their cancer.

Eligibility Criteria

Adults over 18 with Stage IV metastatic pancreatic cancer, who haven't had systemic therapy for it (except certain past therapies if progression occurred >6 months ago). They must have a life expectancy of at least 12 weeks, be able to consent, and agree to use effective contraception. Excluded are those with uncontrolled illnesses or conditions that could affect safety or study compliance, known allergies to trial drugs, inability to take oral meds, recent substance abuse issues, other cancers within the last 5 years (with some exceptions), and active infections.

Inclusion Criteria

Your blood, liver, and kidney function tests must show that they are working properly. Your hemoglobin, white blood cell count, platelet count, liver enzymes, albumin, and kidney function need to be within certain ranges.

My pancreatic cancer is confirmed and measurable.

I am fully active or can carry out light work.

Exclusion Criteria

My condition involves a tumor in the pancreas.

I cannot take pills by mouth or have severe ongoing diarrhea.

I haven't taken any strong medication affecting liver enzymes in the last 14 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I: Dose Escalation

Determine the maximum tolerable dose (MTD) of antroquinonol in combination with nab-paclitaxel and gemcitabine

4 weeks

Weekly visits for 3 weeks, then 1 week off

Phase II: Cohort Expansion

Evaluate the efficacy of antroquinonol at the MTD or MFD/RD in combination with SOC

Ongoing until unacceptable toxicity or progressive disease

Weekly visits for 3 weeks, then 1 week off

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Antroquinonol

Trial Overview The trial is testing Antroquinonol combined with standard chemotherapy drugs nab-paclitaxel and gemcitabine in patients newly diagnosed with metastatic pancreatic cancer. It's a two-part study: first determining the maximum tolerated dose of Antroquinonol (Phase I) and then assessing its effectiveness alongside standard treatment (Phase II).

Participant Groups

Group I: Antroquinonol with SOC Experimental Treatment 1 Intervention

Antroquinonol will first be conducted by dose escalation(200mg TID and 300mgTID) to characterize the safety of antroquinonol in combination with the standard of care (SOC) (nab-paclitaxel + gemcitabine) and to identify the MTD of antroquinonol in patients with metastatic pancreatic cancer. At the cohort expansion part of the study, up to an additional 40 patients will be enrolled at the MTD or MFD/RD.

Who Is Running the Clinical Trial?

Golden Biotechnology Corporation

Lead Sponsor

Trials

12

Recruited

570+

Covance

Industry Sponsor

Trials

124

Recruited

13,300+

Dr. Paul Kirchgraber

Covance

Chief Executive Officer since 2019

MD

Dr. Robert Dow

Covance

Chief Medical Officer since 2020

MD