23 Participants Needed

AZD8186 + Docetaxel for Advanced Cancer

Recruiting at 7 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: National Cancer Institute (NCI)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug (AZD8186) combined with chemotherapy (docetaxel) in patients with advanced solid tumors with specific genetic mutations. The new drug aims to block enzymes needed for cancer growth, while the chemotherapy helps kill or stop the spread of cancer cells. AZD8186 has shown enhanced efficacy when combined with other treatments.

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

The trial does not specify if you need to stop taking your current medications, but you cannot take medications that strongly affect CYP3A4 enzymes. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

What safety information is available for the combination of AZD8186 and Docetaxel in treating advanced cancer?

Docetaxel, also known as Taxotere, has been associated with side effects like neutropenia (low white blood cell count), alopecia (hair loss), skin reactions, and fluid retention. In some cases, it has also been linked to a scleroderma-like illness (a condition causing hardening and tightening of the skin).12345

What makes the drug AZD8186 + Docetaxel unique for advanced cancer treatment?

The combination of AZD8186, a PI3Kbeta inhibitor, with Docetaxel is unique because it targets the PI3K pathway, which is involved in cancer cell growth and survival, potentially enhancing the effectiveness of Docetaxel, a standard chemotherapy drug, by increasing cancer cell death.15678

What data supports the effectiveness of the drug AZD8186 + Docetaxel for advanced cancer?

Research shows that combining docetaxel with PI3K inhibitors, like GDC-0941 and PX-866, enhances the effectiveness of docetaxel in treating cancers such as breast cancer and non-small cell lung cancer by increasing cancer cell death. This suggests that AZD8186, a similar PI3K inhibitor, might also improve the effectiveness of docetaxel in advanced cancer.15789

Who Is on the Research Team?

AM

Alison M Schram

Principal Investigator

JHU Sidney Kimmel Comprehensive Cancer Center LAO

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have specific mutations (PTEN or PIK3CB) and can't be removed by surgery or have spread. Participants must be able to take oral meds, have no major gastrointestinal issues affecting drug absorption, and agree to use contraception. Prior treatments are allowed; however, prior treatment with PI3K/AKT inhibitors or certain other conditions may disqualify a person.

Inclusion Criteria

My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.
You have enough white blood cells called neutrophils.
Your platelet count is at least 100,000 per microliter.
See 24 more

Exclusion Criteria

I have a bleeding condition or am at high risk for bleeding.
You are currently taking any other experimental medications.
My cancer has a RAF or PIK3CA mutation.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive docetaxel IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 orally twice daily for 5 days each week. Cycles repeat every 21 days.

21-day cycles until April 30, 2022
1 visit every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

30 days and then every 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Docetaxel
  • PI3Kbeta Inhibitor AZD8186
Trial Overview The trial is testing the combination of a new drug called AZD8186, which targets enzymes involved in tumor cell growth, with docetaxel, a chemotherapy drug. The goal is to find the safest dose and see if this combo works better than current treatments for these types of tumors.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (docetaxel, PI3Kbeta inhibitor AZD8186)Experimental Treatment4 Interventions

Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:

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Approved in United States as Taxotere for:
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Approved in European Union as Taxotere for:
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Approved in Canada as Taxotere for:
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Approved in Japan as Taxotere for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Docetaxel is an effective treatment for non-small cell lung cancer (NSCLC), showing comparable efficacy to newer platinum-based therapies in advanced stages, and has been approved for use in this context.
Clinical trials are ongoing to explore the best ways to combine docetaxel with other treatments, such as thoracic radiotherapy and molecularly targeted agents, to enhance its effectiveness in various stages of NSCLC.
Docetaxel in non-small cell lung cancer: a review.Davies, AM., Lara, PN., Mack, PC., et al.[2019]
Docetaxel is an effective treatment for advanced non-small cell lung cancer (NSCLC), showing survival benefits in both first- and second-line therapy, and is comparable or superior to other platinum-based chemotherapy options.
The drug has a manageable toxicity profile and has shown promising results when combined with novel targeted agents in Phase II studies, indicating its versatility in treatment regimens.
Docetaxel in advanced non-small cell lung cancer.Wakelee, H., Ramalingam, S., Belani, CP.[2018]
Docetaxel shows significant efficacy in treating advanced non-small cell lung cancer, with a 30% partial response rate in chemotherapy-naive patients and 20% in those who had previously failed platinum-based treatments, based on six phase II studies involving 268 patients.
The primary side effect of docetaxel is neutropenia, while fluid retention is common but usually manageable with corticosteroids, indicating that the treatment has a manageable safety profile.
Summary of phase II data of docetaxel (Taxotere), an active agent in the first- and second-line treatment of advanced non-small cell lung cancer.Fossella, FV., Lee, JS., Berille, J., et al.[2018]

Citations

Docetaxel in non-small cell lung cancer: a review. [2019]
A multicenter phase 1 study of PX-866 in combination with docetaxel in patients with advanced solid tumours. [2021]
GDC-0941, a novel class I selective PI3K inhibitor, enhances the efficacy of docetaxel in human breast cancer models by increasing cell death in vitro and in vivo. [2022]
Docetaxel in advanced non-small cell lung cancer. [2018]
A randomized, phase 2 trial of Docetaxel with or without PX-866, an irreversible oral phosphatidylinositol 3-kinase inhibitor, in patients with relapsed or metastatic non-small-cell lung cancer. [2020]
Summary of phase II data of docetaxel (Taxotere), an active agent in the first- and second-line treatment of advanced non-small cell lung cancer. [2018]
Scleroderma in association with the use of docetaxel (taxotere) for breast cancer. [2018]
A Phase Ib, open-label, dose-finding study of alpelisib in combination with paclitaxel in patients with advanced solid tumors. [2019]
Synergistic effect of the γ-secretase inhibitor PF-03084014 and docetaxel in breast cancer models. [2023]
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