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Mitotic Inhibitor

AZD8186 + Docetaxel for Advanced Cancer

Phase 1

Waitlist Available

Led By Alison M Schram

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective

PTEN loss of function mutation or PIK3CB gain of function mutation identified by local Clinical Laboratory Improvement Act (CLIA) certified next generation sequencing (NGS)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is testing the effects of a new drug, AZD8186, when given with the standard chemotherapy drug docetaxel, in patients with solid tumors that have certain mutations and have spread or can't be removed by surgery.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects include reactions related to blocking enzymes needed for cell growth which could affect normal cells as well as cancer cells. Chemotherapy like docetaxel can cause hair loss, nausea, fatigue, low blood counts leading to increased infection risk and bleeding problems.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.

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My cancer has a specific genetic change detected by a certified test.

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My breast cancer is either estrogen receptor positive and HER2 negative, or it is triple negative.

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I have never received docetaxel treatment.

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I can swallow pills and don’t have stomach issues affecting medicine absorption.

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My kidney function, measured by creatinine or its clearance, is within the normal range.

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My advanced cancer has a PTEN or PIK3CB mutation.

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I have a tumor that can be measured and is big enough according to specific guidelines.

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I have never been treated with docetaxel.

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I have a tumor that can be measured and is larger than 1 cm.

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I have advanced prostate cancer resistant to standard treatments.

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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Adverse Events (AEs) Grades 3-5

Number of Participants With Dose Limiting Toxicity (DLT)

Secondary outcome measures

Clinical Benefit Rate (CBR) Defined as Complete Response (CR), Partial Response (PR), or Stable Disease

Drug-drug Interaction Between Docetaxel and PI3Kbeta Inhibitor AZD8186

Objective Response Rate (ORR)

Other outcome measures

Co-mutated genes in PTEN or PIK3CB mutated tumors

Isoform-specific AKT inhibition

Ovulation Inhibition

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (docetaxel, PI3Kbeta inhibitor AZD8186)Experimental Treatment4 Interventions

Patients receive docetaxel IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~5620

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,130 Total Patients Enrolled

Alison M SchramPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO

Media Library

Docetaxel (Mitotic Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03218826 — Phase 1

Cancer Research Study Groups: Treatment (docetaxel, PI3Kbeta inhibitor AZD8186)

Cancer Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT03218826 — Phase 1

Docetaxel (Mitotic Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03218826 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are presently being welcomed into this research endeavor?

"Unfortunately, this trial has been closed to new participants as of October 18th 2022. If you are looking for alternative opportunities, there are currently 7804 trials that involve malignant neoplasms and 321 Pharmacological Studies seeking volunteers."

Answered by AI

In which clinical scenarios is Pharmacological Study prescribed?

"Pharmacological Study has been employed to successfully treat malignant neoplasms, advance directives, and sarcoma."

Answered by AI

Are enrollments being accepted at this time for participation in the trial?

"The information hosted on clinicaltrials.gov confirms that this particular study is no longer searching for volunteers to participate in their trial. The initial post was made on March 16th 2018, while the last update occurred October 18th 2022. Although this investigation has finished recruitment, there are currently 8125 other trials actively seeking patients across the world."

Answered by AI

Are there any adverse effects associated with participating in this Pharmacological Study?

"Our experts at Power rated the safety of Pharmacological Study a 1 on account of it being in Phase 1, thus having limited evidence to attest its efficacy or security."

Answered by AI

Are there various sites hosting this experiment in the metropolis?

"This clinical trial is taking place at the Memorial Sloan Kettering Cancer Center in New york, National Cancer Institute Developmental Therapeutics Clinic in Bethesda and 6 additional sites including Memorial Sloan Kettering Westchester in Harrison."

Answered by AI

What other experiments have been conducted regarding Pharmacological Study?

"As of now, 321 investigations into Pharmacological Study are underway. Of those active trials, 126 are in Phase 3. Centres spread across the globe have begun to offer this treatment with Fuzhou, Fujian being a major hub out of 22392 total locations conducting research on it."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery

2018. "PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03218826.

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