Individualizing Pazopanib Therapy by exploRing the Role of Early Metabolic responsE and Drug Exposure as a preDICTor for Treatment Outcome in Patients With STS (PREDICT)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01995981 |
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Recruitment Status :
Completed
First Posted : November 27, 2013
Last Update Posted : December 19, 2017
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Sponsor:
Radboud University
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Radboud University
| Tracking Information | ||||||||||
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| First Submitted Date | November 21, 2013 | |||||||||
| First Posted Date | November 27, 2013 | |||||||||
| Last Update Posted Date | December 19, 2017 | |||||||||
| Actual Study Start Date | December 2013 | |||||||||
| Actual Primary Completion Date | November 10, 2017 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures |
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| Change History | ||||||||||
| Current Secondary Outcome Measures |
Adverse events (CTCAE v4.0) [ Time Frame: 2 weeks and 8 weeks after start treatment ] | |||||||||
| Original Secondary Outcome Measures | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | Individualizing Pazopanib Therapy by exploRing the Role of Early Metabolic responsE and Drug Exposure as a preDICTor for Treatment Outcome in Patients With STS | |||||||||
| Official Title | Individualizing Pazopanib Therapy by exploRing the Role of Early Metabolic responsE and Drug Exposure as a preDICTor for Treatment Outcome in Patients With STS | |||||||||
| Brief Summary | This study is a phase IV post registration prospective observational feasibility study in patients with metastatic soft tissue sarcoma. Pazopanib is the registered treatment for patients with advanced soft tissue sarcoma after chemotherapy with doxorubicin or ifosfamide.
The primary objectives are:
The secondary objectives are:
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| Detailed Description | Not Provided | |||||||||
| Study Type | Observational | |||||||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Retention: Samples With DNA Description: whole blood
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| Sampling Method | Non-Probability Sample | |||||||||
| Study Population | Patients with advanced soft tissue sarcoma who have an indication for pazopanib treatment. | |||||||||
| Condition | Sarcoma, Soft Tissue | |||||||||
| Intervention | Drug: Pazopanib
Other Name: Votrient
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| Study Groups/Cohorts | Advanced soft tissue sarcoma patients
Advanced soft tissue sarcoma patients, who have an indication for pazopanib treatment.
Intervention: Drug: Pazopanib
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| Publications * | van der Graaf WT, Blay JY, Chawla SP, Kim DW, Bui-Nguyen B, Casali PG, Schöffski P, Aglietta M, Staddon AP, Beppu Y, Le Cesne A, Gelderblom H, Judson IR, Araki N, Ouali M, Marreaud S, Hodge R, Dewji MR, Coens C, Demetri GD, Fletcher CD, Dei Tos AP, Hohenberger P; EORTC Soft Tissue and Bone Sarcoma Group; PALETTE study group. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2012 May 19;379(9829):1879-86. doi: 10.1016/S0140-6736(12)60651-5. Epub 2012 May 16. | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Completed | |||||||||
| Actual Enrollment |
22 | |||||||||
| Original Estimated Enrollment |
30 | |||||||||
| Actual Study Completion Date | November 10, 2017 | |||||||||
| Actual Primary Completion Date | November 10, 2017 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | Netherlands, United Kingdom | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT01995981 | |||||||||
| Other Study ID Numbers | UMCN-ONCO-201303 2013-003533-16 ( EudraCT Number ) |
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| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement | Not Provided | |||||||||
| Responsible Party | Radboud University | |||||||||
| Study Sponsor | Radboud University | |||||||||
| Collaborators | GlaxoSmithKline | |||||||||
| Investigators |
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| PRS Account | Radboud University | |||||||||
| Verification Date | June 2015 | |||||||||