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A Dose Finding Study of TKM-080301 Infusion in Neuroendocrine Tumors (NET) and Adrenocortical Carcinoma (ACC) Patients
NCT01262235 · View on ClinicalTrials.gov ↗
Study Summary
This study will be a Phase I/II, open-label, non-randomized, dose-finding trial conducted at multiple clinical centers. The study is designed to determine the safety, tolerability and PK of TKM-080301 in adult patients with solid tumors or lymphomas that are refractory to standard therapy or for whom there is no standard therapy. After the determination of the maximum tolerated dose this dose will be utilized in an expansion cohort or subjects with refractory neuroendocrine tumors (NET) or adrenocortical carcinoma (ACC) tumors.
Conditions Studied
Interventions
- DRUG TKM-080301
Study Locations (8)
Arizona
- Scottsdale Healthcare Research Institute — Scottsdale
- Mayo Clinic Arizona — Scottsdale
Florida
- Moffitt Cancer Center — Tampa
Iowa
- University of Iowa/Holden Comprehensive Cancer Center — Iowa City
Massachusetts
- Dana Farber Cancer Institute — Boston
Michigan
- University of Michigan Comprehensive Cancer Center — Ann Arbor
Minnesota
- Mayo Clinic — Rochester
Texas
- Westchase Oncology Center — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2010-12 |
| Est. Completion | 2015-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01262235
The ClinicalTrials.gov registry entry for NCT01262235 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arbutus Biopharma Corporation, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Cancer appearing as the primary indexed condition, and to 1 intervention — of which TKM-080301 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01262235 reports 8 study locations spanning 7 distinct geographic areas — top geographies include Arizona, Florida, Iowa. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01262235 about?
NCT01262235 is a clinical study titled "A Dose Finding Study of TKM-080301 Infusion in Neuroendocrine Tumors (NET) and Adrenocortical Carcinoma (ACC) Patients". This study will be a Phase I/II, open-label, non-randomized, dose-finding trial conducted at multiple clinical centers. The study is designed to determine the safety, tolerability and PK of TKM-080301 in adult patients with solid tumors or lymphomas that are refractory to standard therapy or for who...
What is the current status of trial NCT01262235?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2010-12. Estimated completion is 2015-08.
What conditions does trial NCT01262235 study?
This clinical trial studies the following conditions: Cancer, Neuroendocrine Tumors, Adrenocortical Carcinoma, ACC, NET. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01262235?
The interventions under investigation include: TKM-080301 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01262235?
This trial is sponsored by Arbutus Biopharma Corporation, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01262235 being conducted?
This trial has 8 study locations across Arizona, Florida, Iowa, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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