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NCT02240238 · ClinicalTrials.gov registry record · Phase 1
Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer
A Phase 1 study of Solid Tumors, sponsored by NanoCarrier Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 119
- Enrollment target
- 20
- Study locations
NCT02240238: Completed Phase 1 study of Solid Tumors, sponsored by NanoCarrier Co..
NCT02240238 is a Phase 1 study of Solid Tumors that has completed, run by NanoCarrier Co.. The registered enrollment target is 119 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02240238, a Phase 1 study of Solid Tumors, has completed, sponsored by NanoCarrier Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 119 participants
- Enrollment target
- 20
- Study locations
Study Summary
In the dose escalation phase (Part 1), this study will determine the dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD) and recommended Phase 2 (RPII) dose of NC 6004 in combination with gemcitabine. In the expansion phase of the study (Part 2), study will evaluate the activity, safety, and tolerability at the RPII dose identified in Part 1 in patients with squamous NSCLC, biliary tract, and bladder cancer.
Primary Outcome
In the dose-escalation phase of the study (Part 1), to determine the dose-limiting toxicities (DLTs), MTD, and RPII dose of NC-6004 in combination with gemcitabine
Conditions Studied
Interventions
- DRUG Gemcitabine
- DRUG NC-6004
Study Locations (20)
Other
- Complex Oncology Center - Shumen EOOD - Shumen
- Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - Meldola
- ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda - Milan
- Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie - Krakow
- Med-Polonia Sp. z o.o. - Poznan
- Fundeni Clinical Institute - Bucharest
- Coltea Clinical Hospital - Bucharest
- Prof Dr I Chiricuta Institute of Oncology - Cluj-Napoca
- Oncology Center Sfantul Nectarie - Craiova
California
- California Cancer Associates for Research and Excellence - Encinitas
- UC San Diego Moores Cancer Center - La Jolla
- Pacific Hematology Oncology Associates - San Francisco
Texas
- University of Texas Southwestern Medical Center - Dallas
- MD Anderson Cancer Center - Houston
Illinois
- Northwestern University Feinberg School of Medicine - Chicago
Massachusetts
- Tufts Medical Center - Boston
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Ohio
- University Hospitals Case Medical Center - Cleveland
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2014-05 |
| Est. Completion | 2019-05-06 |
| Phase | Phase 1 |
What the finished NCT02240238 record still lists
NCT02240238 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which Gemcitabine is the first listed.
NCT02240238 names 20 study sites across 9 states, led by Other, California, Texas.
Frequently Asked Questions
What is clinical trial NCT02240238 about?
NCT02240238 is a clinical study titled "Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer". In the dose escalation phase (Part 1), this study will determine the dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD) and recommended Phase 2 (RPII) dose of NC 6004 in combination with gemcitabine. In the expansion phase of the study (Part 2), study will evaluate the activity, safe...
What is the current status of trial NCT02240238?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 119 participants. The study started on 2014-05. Estimated completion is 2019-05-06.
What conditions does trial NCT02240238 study?
This clinical trial studies the following conditions: Solid Tumors.
What interventions are being tested in trial NCT02240238?
The interventions under investigation include: Gemcitabine (DRUG), NC-6004 (DRUG).
Who is sponsoring clinical trial NCT02240238?
This trial is sponsored by NanoCarrier Co., which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02240238 being conducted?
This trial has 20 study locations across California, Illinois, Massachusetts, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Solid Tumors
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 NCT02240238's enrollment target sits among peer trials
119 48th of 125 higher than 78 of 125 other Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumors 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
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A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
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Study of AUBE00 in Patients With Solid Tumors
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