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NCT03218826 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Advanced Malignant Solid Neoplasm and Anatomic Stage III Breast Cancer AJCC v8, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
23
Enrollment target
8
Study locations

NCT03218826 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Anatomic Stage III Breast Cancer AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 23 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (87% lower). The trial reports 8 study locations across 5 states.

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The verdict

NCT03218826, a Phase 1 study of Advanced Malignant Solid Neoplasm and Anatomic Stage III Breast Cancer AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
23 participants
Enrollment target
8
Study locations

Study Summary

This phase I trial studies the side effects and best dose of PI3Kbeta inhibitor AZD8186 when given together with docetaxel in treating patients with solid tumors with PTEN or PIK3CB mutations that have spread to other places in the body (metastatic) or cannot be removed by surgery. PI3Kbeta inhibitor AZD8186 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving PI3Kbeta inhibitor AZD8186 and docetaxel may work better in treating patients with solid tumors.

Interventions

  • DRUG Docetaxel
  • OTHER Laboratory Biomarker Analysis
  • OTHER Pharmacological Study
  • DRUG PI3Kbeta Inhibitor AZD8186

Study Locations (8)

Maryland

  • Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
  • National Cancer Institute Developmental Therapeutics Clinic - Bethesda
  • National Institutes of Health Clinical Center - Bethesda

New York

  • Memorial Sloan Kettering Westchester - Harrison
  • Memorial Sloan Kettering Cancer Center - New York

Colorado

  • UCHealth University of Colorado Hospital - Aurora

New Jersey

  • Memorial Sloan Kettering Monmouth - Middletown

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2018-09-24
Est. Completion 2026-10-03
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT03218826

The ClinicalTrials.gov registry entry for NCT03218826 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (87% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 4 interventions - of which Docetaxel is the first listed.

NCT03218826 reports 8 study locations spanning 5 distinct geographic areas - top geographies include Maryland, New York, Colorado.

Frequently Asked Questions

What is clinical trial NCT03218826 about?

NCT03218826 is a clinical study titled "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". This phase I trial studies the side effects and best dose of PI3Kbeta inhibitor AZD8186 when given together with docetaxel in treating patients with solid tumors with PTEN or PIK3CB mutations that have spread to other places in the body (metastatic) or cannot be removed by surgery. PI3Kbeta inhibito...

What is the current status of trial NCT03218826?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2018-09-24. Estimated completion is 2026-10-03.

What conditions does trial NCT03218826 study?

This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Anatomic Stage IIIA Breast Cancer AJCC v8.

What interventions are being tested in trial NCT03218826?

The interventions under investigation include: Docetaxel (DRUG), Laboratory Biomarker Analysis (OTHER), Pharmacological Study (OTHER), PI3Kbeta Inhibitor AZD8186 (DRUG).

Who is sponsoring clinical trial NCT03218826?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03218826 being conducted?

This trial has 8 study locations across Colorado, Maryland, New Jersey, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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