Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06498648 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma
A Phase 1 study of Metastatic Soft Tissue Sarcoma and Advanced Soft Tissue Sarcoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
- 1
- Study location
NCT06498648 is a Phase 1 study of Metastatic Soft Tissue Sarcoma and Advanced Soft Tissue Sarcoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 74 participants, below the 134-participant average among 12 other Metastatic Soft Tissue Sarcoma trials with a reported enrollment target (45% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06498648, a Phase 1 study of Metastatic Soft Tissue Sarcoma and Advanced Soft Tissue Sarcoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial tests the side effects and best dose of abemaciclib when added to gemcitabine and compares the effectiveness of that treatment to the usual treatment of gemcitabine with docetaxel for the treatment of patients with soft tissue sarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) (phase 1) or patients with leiomyosarcoma or dedifferentiated liposarcoma (phase 2). Abemaciclib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Giving abemaciclib with gemcitabine may be safe and effective when compared to treatment with gemcitabine and docetaxel for patients with advanced or metastatic soft tissue sarcoma or leiomyosarcoma or dedifferentiated liposarcoma.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Docetaxel
- PROCEDURE Biopsy Procedure
- DRUG Abemaciclib
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2026-03-18 |
| Est. Completion | 2027-01-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06498648
The ClinicalTrials.gov registry entry for NCT06498648 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 134-participant average among 12 other Metastatic Soft Tissue Sarcoma trials with a reported enrollment target (45% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Metastatic Soft Tissue Sarcoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06498648 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06498648 about?
NCT06498648 is a clinical study titled "Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma". This phase I/II trial tests the side effects and best dose of abemaciclib when added to gemcitabine and compares the effectiveness of that treatment to the usual treatment of gemcitabine with docetaxel for the treatment of patients with soft tissue sarcoma that may have spread from where it first st...
What is the current status of trial NCT06498648?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2026-03-18. Estimated completion is 2027-01-31.
What conditions does trial NCT06498648 study?
This clinical trial studies the following conditions: Metastatic Soft Tissue Sarcoma, Advanced Soft Tissue Sarcoma, Metastatic Dedifferentiated Liposarcoma, Metastatic Leiomyosarcoma, Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8.
What interventions are being tested in trial NCT06498648?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Docetaxel (DRUG), Biopsy Procedure (PROCEDURE), Abemaciclib (DRUG).
Who is sponsoring clinical trial NCT06498648?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06498648 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Soft Tissue Sarcoma
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.
-
First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma
RECRUITING · Phase 1
-
Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Sarcoma or Colorectal Metastases
RECRUITING · Phase 1
-
SAINT:Trabectedin, Ipilimumab and Nivolumab for Previously Treated Advanced Soft Tissue Sarcoma
RECRUITING · Phase 1
-
Zanzalintinib in Combination With Ipilimumab and Nivolumab in Patients With Metastatic Soft Tissue Sarcoma
RECRUITING · Phase 1
-
T Cell Membrane-Anchored Tumor-Targeted IL12 -Modified TIL Cell Therapy (attIL12-TIL) for Advanced/Metastatic Soft Tissue and Bone Sarcoma Patients.
RECRUITING · Phase 1
-
Study of LVGN3616 and LVGN6051±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors
ACTIVE NOT RECRUITING · Phase 1
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.