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NCT01956669 · ClinicalTrials.gov registry record · Phase 2
Pazopanib Paediatric Phase II Trial Children's Oncology Group (COG) in Solid Tumors
A Phase 2 study of Solid Tumours, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
- 20
- Study locations
NCT01956669: Completed Phase 2 study of Solid Tumours, sponsored by Novartis Pharmaceuticals.
NCT01956669 is a Phase 2 study of Solid Tumours that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 57 participants, below the 140-participant average among 9 other Solid Tumours trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01956669, a Phase 2 study of Solid Tumours, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
ORR was defined as the percentage of participants achieving either a Complete Response (CR) or partial Response (PR) based on the Investigator review. The responses were assessed by CT or MRI based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST1.1). CR, disappearance of all target and non-target lesions; PR, at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study enrollment, also no new lesion o
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 |
What the finished NCT01956669 record still lists
NCT01956669 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 140-participant average among 9 other Solid Tumours trials with a reported enrollment target (59% lower).
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.
NCT01956669 names 20 study sites across 13 states, led by California, Florida, Missouri.
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.
What interventions are being tested in trial NCT01956669?
The interventions under investigation include: Pazopanib (DRUG).
Who is sponsoring clinical trial NCT01956669?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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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 NCT01956669's enrollment target sits among peer trials
57 7th of 9 higher than 3 of 9 other Solid Tumours trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumours 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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