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Pazopanib Paediatric Phase II Trial Children's Oncology Group (COG) in Solid Tumors
NCT01956669 · View on ClinicalTrials.gov ↗
Study Summary
The study design was an open-label Phase II pediatric clinical study. The purpose of Study X2203 was to identify any efficacy signal in subjects with the disease subtypes under study, when treated with pazopanib monotherapy. Furthermore, it was to define the toxicities of pazopanib in children, as well as examine biological markers, e.g. cytokines and angiogenic factors, that could help further characterize any response of pazopanib in children. Pazopanib was administered as monotherapy in tablet and powder suspension formulations at daily doses of 450 mg/m2/dose or 225 mg/m2/dose, respectively. The first 6 enrolled subjects receiving oral suspension formulation were assessed for tolerability and extended PK sampling; and, only if pazopanib was tolerated, subsequent subjects were enrolled at the same starting dose with the suspension. Dose escalation was not permitted. For the tablet, a dosing nomogram was used based on the subject's BSA. Dose reduction was dependent upon the toxicity of pazopanib and disease status of the infants, toddlers, children, adolescents, and young adults. Subjects could be as young as 1 year-old infants to screen for enrollment. Subjects were assessed for initial response after 8 weeks of treatment prior to Cycle 3. A cycle was defined as 28 days of pazopanib treatment with no rest period between cycles. Treatment was administered continuously once daily. Treatment was to be discontinued if there was evidence of disease progression, unacceptable treatment-related toxicity, pregnancy. Histological classification was an important diagnostic inclusion in these subjects with a wide variety of refractory solid tumors, i.e. 7 different tumor types and each being a cohort.
Conditions Studied
Interventions
- DRUG Pazopanib
Study Locations (20)
California
- Novartis Investigative Site — Long Beach
- Novartis Investigative Site — Madera
- Novartis Investigative Site — Orange
- Novartis Investigative Site — Palo Alto
- Novartis Investigative Site — San Francisco
Florida
- Novartis Investigative Site — Orlando
- Novartis Investigative Site — St. Petersburg
Missouri
- Novartis Investigative Site — Kansas City
- Novartis Investigative Site — St Louis
North Carolina
- Novartis Investigative Site — Chapel Hill
- Novartis Investigative Site — Charlotte
Connecticut
- Novartis Investigative Site — Hartford
Illinois
- Novartis Investigative Site — Chicago
Indiana
- Novartis Investigative Site — Indianapolis
Minnesota
- Novartis Investigative Site — Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2014-10-08 |
| Est. Completion | 2019-11-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01956669
The ClinicalTrials.gov registry entry for NCT01956669 describes a study currently listed as completed. It is categorized as Phase 2, 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 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Solid Tumours appearing as the primary indexed condition, and to 1 intervention — of which Pazopanib 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: NCT01956669 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Missouri. 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 NCT01956669 about?
NCT01956669 is a clinical study titled "Pazopanib Paediatric Phase II Trial Children's Oncology Group (COG) in Solid Tumors". The study design was an open-label Phase II pediatric clinical study. The purpose of Study X2203 was to identify any efficacy signal in subjects with the disease subtypes under study, when treated with pazopanib monotherapy. Furthermore, it was to define the toxicities of pazopanib in children, as w...
What is the current status of trial NCT01956669?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2014-10-08. Estimated completion is 2019-11-05.
What conditions does trial NCT01956669 study?
This clinical trial studies the following conditions: Solid Tumours. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01956669?
The interventions under investigation include: Pazopanib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01956669?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01956669 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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