Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 1 study of Advanced Malignant Solid Neoplasm and Anatomic Stage III Breast Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The number of DLTs at each dose level will determine the MTD or RP2D of PI3Kbeta inhibitor AZD8186 when administered in combination with docetaxel in patients with PTEN or PIK3CB mutated advanced solid tumors.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2018-09-24 |
| Est. Completion | 2026-10-03 |
| Phase | Phase 1 |
What the registry record for NCT03218826 still lists
NCT03218826 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (87% lower).
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 lists 8 locations in 5 states (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.
Learn More About Clinical Trials
Similar trials for Advanced Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03218826's enrollment target sits among peer trials
23 90th of 108 higher than 18 of 108 other Advanced Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors
RECRUITING · Phase 1
-
Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors
RECRUITING · Phase 1
-
Phase I/II Randomized Study of NBTXR3 Activated by Abscopal or RadScopal Radiation in Combination With Immunotherapy (Anti-PD-1/L-1) for Patients With Advanced Solid Malignancies
RECRUITING · Phase 1
-
The Immune Effects of Fermented Wheat Germ Nutritional Supplementation in Patients With Advanced Solid Tumor Cancers Being Treated With Standard of Care Checkpoint Inhibitors
RECRUITING · Phase 1
-
Studying TAK-243 in Patients With Advanced Cancer
RECRUITING · Phase 1
-
Testing How the Body Responds to the Drug CBX-12 in Patients With Advanced Solid Cancers
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03616041 · 23 participants
Capsule Endoscopy for Severe Hematochezia
- NCT04348747 · 23 participants · Phase 2
Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
- NCT04587687 · 23 participants · Phase 2
Brentuximab Vedotin and Bendamustine for the Treatment of Relapsed or Refractory Follicular Lymphoma
- NCT04715022 · 23 participants · Phase 1
Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance (Vitamin C Study)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI