Antroquinonol for Metastatic Pancreatic Cancer

Not currently recruiting at 12 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called antroquinonol for individuals with Stage IV metastatic pancreatic cancer. The goal is to determine if combining antroquinonol with standard chemotherapy drugs nab-paclitaxel and gemcitabine is safe and effective. The trial will first identify the optimal dose of antroquinonol, then assess its efficacy. Individuals recently diagnosed with metastatic pancreatic cancer who have not received prior treatment may be suitable candidates. As a Phase 1/Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial group, offering a chance to be among the first to benefit from this new approach.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not take any drugs known to strongly affect certain liver enzymes (CYP2C19, CYP3A4, CYP2C8, and CYP2E1) within 14 days before starting the study and during the study. If you're on such medications, you may need to stop them.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that antroquinonol is generally safe and well-tolerated when used alone. One study found that taking up to 600 mg daily for four weeks did not cause any major safety issues. This trial will test antroquinonol with standard chemotherapy drugs, nab-paclitaxel and gemcitabine, to assess its safety for people with advanced pancreatic cancer. Early testing will help determine the safest dose. So far, antroquinonol has not caused serious side effects at the doses tested, which is encouraging for potential trial participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Antroquinonol for metastatic pancreatic cancer because it introduces a unique approach by combining with the standard treatment of nab-paclitaxel and gemcitabine. Unlike typical treatments that mainly focus on stopping cell division, Antroquinonol works by potentially inhibiting specific enzymes related to cancer growth, offering a novel mechanism of action. This new angle on tackling cancer cells might provide more effective results and possibly enhance patient outcomes compared to current options.

What evidence suggests that antroquinonol might be an effective treatment for metastatic pancreatic cancer?

In this trial, participants will receive Antroquinonol alongside standard treatments for advanced pancreatic cancer. Studies have shown promising results for this combination. Specifically, a previous study with 40 patients demonstrated that this combination allowed patients to live for an average of 5.3 months without their cancer worsening. Additionally, the average overall survival was 14.1 months, a significant improvement compared to the usual 8.5 months with standard treatments alone. These findings suggest that adding Antroquinonol may help patients live longer and slow the progression of their cancer. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.3_suppl.648

A phase I/II study of antroquinonol in combination with nab ... In the phase II study of 40 patients, the median PFS was 5.3 (95% CI: 3.7–7.5) months and 6-month PFS rate was 40% (95% CI: 21%–57%), whereas ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03310632

NCT03310632 | Determine Function of Antroquinonol in ... The proposed clinical trial is a Phase I/II study designed to evaluate antroquinonol in combination with nab-paclitaxel and gemcitabine in first line treatment ...

3. biospace.com biospace.com/asco-gi-2024-golden-biotech-s-antroquinonol-shows-significantly-prolonged-survival-in-untreated-metastatic-pancreatic-cancer-patients

ASCO GI 2024: Golden Biotech's Antroquinonol Shows ... The trial showed a positive median overall survival (mOS) of 14.1 months, which is a substantial increase compared to 8.5 months mOS observed in the standard ...

4. meetings.asco.org meetings.asco.org/abstracts-presentations/229456

A phase I/II study of antroquinonol in combination with nab- ... Conclusions: In this phase I/II trial, antroquinonol plus Gem/Nab-P showed good efficacy in survival and less adverse events than a first-line strategy of Gem/ ...

5. goldenbiotech.com goldenbiotech.com/en/news.php?act=view&id=31

Golden Biotech Announces Positive Results with Longer ... Antroquinonol in combination with standard treatment appears to have a significant survival advantage over current first-line treatments for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4665158/

A phase I multicenter study of antroquinonol in patients ... In conclusion, antroquinonol administered up to a dose level of 600 mg daily for 4 weeks was generally safe and tolerable, as no particular safety concerns or ...

7. npcf.us npcf.us/clinical-trials/determine-function-of-antroquinonol-in-combination-with-soc-in-first-line-metastatic-pancreatic-cancer/

Determine Function Of Antroquinonol In Combination With ... The first part of study will focus on the treatment of pancreatic cancer with 200 mg TID and 300 mg TID, clinical treatment duration of 4 weeks, to determine ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0955286311001422

Antroquinonol, a natural ubiquinone derivative, induces ... In summary, the data suggest that antroquinonol induces anticancer activity in human pancreatic cancers through an inhibitory effect on PI3-kinase/Akt/mTOR ...

9. withpower.com withpower.com/trial/phase-2-pancreatic-neoplasms-11-2017-a14d7

Antroquinonol for Metastatic Pancreatic Cancer This trial tests a new drug, antroquinonol, combined with standard chemotherapy drugs to treat advanced pancreatic cancer. It aims to find the safest dose ...