What side effects are associated with this type of intervention?

The most common treatments for pancreatic cancer, such as the combination of nab-paclitaxel and gemcitabine, are associated with several side effects. These include neutropenia (a decrease in white blood cells), fatigue, neuropathy (nerve damage causing pain or numbness), diarrhea, and thrombocytopenia (a decrease in platelets). In clinical trials, these treatments have shown higher response rates and improved survival but come with significant grade 3 or 4 toxicities, including febrile neutropenia, severe fatigue, and gastrointestinal issues.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including chemotherapeutic agents like gemcitabine and nab-paclitaxel, which are often used in combination. FOLFIRINOX, a regimen that includes fluorouracil, leucovorin, irinotecan, and oxaliplatin, is another approved treatment. These treatments primarily target cancer cell proliferation and survival. While Antroquinonol is being studied for its ability to inhibit the PI3K/AKT/mTOR pathway, similar mechanisms are targeted by other investigational drugs and therapies, but specific FDA-approved drugs with this exact mechanism are not highlighted in the provided context.

What other types of research exist?

Promising alternatives to Antroquinonol for pancreatic cancer treatment include: 1) Metformin, which activates AMPK and downregulates mTOR and CFTR pathways, showing efficacy in slowing cyst growth in ADPKD models. 2) Sirolimus, which has shown potential in reducing liver volume in transplant patients and may have applications in cancer treatment. 3) Everolimus, which has been studied in combination with other agents for its effects on tumor growth. These agents target similar pathways and have shown potential in clinical settings.

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Antroquinonol for Metastatic Pancreatic Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Golden Biotechnology Corporation

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Possible side effects include reactions related to the immune system due to Antroquinonol or chemotherapy agents like nab-paclitaxel and gemcitabine. These can range from mild allergic responses to severe organ inflammation. Other common chemo-related side effects may involve fatigue, digestive issues such as nausea or diarrhea, blood cell count changes leading to increased infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

MTD( phase I)

tumor assessment in millimeters

Secondary study objectives

Area Under the Curve

Body Surface Area in meter^2

CA-19-9 Antigen

+2 more

Side effects data

From 2018 Phase 2 trial • 31 Patients • NCT02047344

97%

Gastrointestinal disorders

65%

General disorders and administration site conditions

55%

Respiratory, thoracic and mediastinal disorders

35%

Metabolism and nutrition disorders

35%

Nervous system disorders

26%

Musculoskeletal and connective tissue disorders

19%

Infections and infestations

19%

Investigations

13%

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

13%

Renal and urinary disorders

13%

Psychiatric disorders

Cardiac disorders

Tachycardia

100%

80%

60%

40%

20%

Study treatment Arm

Antroquinonol (Hocena)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Antroquinonol with SOCExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Antroquinonol

Not yet FDA approved

Do I qualify?Apply below to find out

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 pancreatic cancer, such as gemcitabine and nab-paclitaxel, work by interfering with the DNA replication process, thereby inhibiting cancer cell proliferation and inducing apoptosis. Antroquinonol, currently under study, is believed to inhibit cancer cell growth and induce apoptosis through multiple pathways, including the inhibition of the PI3K/AKT/mTOR pathway, which is crucial for cell survival and proliferation. Understanding these mechanisms is vital for pancreatic cancer patients as it helps in selecting targeted therapies that can effectively disrupt cancer cell growth and improve treatment outcomes.