Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02212015
Other study ID # GISG-06
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date July 2014
Est. completion date July 1, 2020

Study information

Verified date January 2022
Source Heidelberg University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Open-label phase II trial investigating the efficacy and safety of the investigational combination of pazopanib and paclitaxel.


Description:

Open-label phase II trial investigating the efficacy and safety of the investigational combination of pazopanib and paclitaxel.This multi-center, open-label, prospective, single arm phase II study was designed to evaluate the clinical efficacy and safety of the experimental combination of pazopanib with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.The safety evaluations (physical examination, laboratory checks as defined in protocol, toxicity/adverse event assessment according Eastern Cooperative Oncology Group version 4.0) are scheduled every cycle at day 1, 8, 15 and 29 (= day 1 of the next cycle).


Recruitment information / eligibility

Status Terminated
Enrollment 26
Est. completion date July 1, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up. Note: Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging studies) and obtained prior to signing informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol. - Age = 18 years - Life expectancy > 3 months - Ability to swallow tablets - Histological confirmed angiosarcoma, primary and secondary angiosarcoma (e.g. radiation-induced or angiosarcoma in chronical lymphedema) are eligible. - Tumor must be locally advanced (unresectable) or metastatic. A progression must be documented within a 6-month period prior to screening. - Eastern Cooperative Oncology Group performance status = 2 - At least one measurable skin lesion or one measurable radiological (CT or MRI) target lesion (RECIST 1.1) - Adequate organ system function as described in protocol - A female is eligible to enter and participate in this study if she is either of non childbearing potential (defined in protocol) or childbearing potential with negative pregnancy test within 2 weeks prior to the first dose of study drug and agrees to use adequate contraception (as defined in protocol) during the study and for 30 days after the last dose of study drug. - All sexually active male patients must agree to use adequate methods of birth control (see protocol) throughout the study and for 30 days after the last dose of study drug. Exclusion Criteria: - Patients who need an active treatment for another malignant disease other than angiosarcoma - Prior treatment with taxane within the last 12 months before study entry - History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal sarcomatosis.(see protocol) - Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding (see protocol) - Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product (see protocol) - Presence of uncontrolled infection - QT prolongation interval (QTc) > 480 msec. - Clinically significant cardiovascular disorders within the past 6 months - Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer - Poorly controlled hypertension (see protocol) - Evidence of active bleeding or bleeding diathesis - Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels - Uncontrolled seizures, disorders of the CNS or psychiatric disorders which may put patient safety at risk, prevent giving informed consent or impact the patient's compliance with the use of study medication - Women who are pregnant or breast feeding - Patients who are not able or not willing to interrupt the intake of medications that are not allowed according to study protocol for at least 14 days before start of study medication and for the whole study period - Chemotherapy or radiotherapy within 14 days before start of study medication - Any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is progressing in severity, except alopecia

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pazopanib + Paclitaxel
pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.

Locations

Country Name City State
Austria Universitätsklinik Graz Graz
Austria Universitätsklinik Wien Wien
Germany Helios-Klinikum Bad Saarow Bad Saarow
Germany Helios Klinikum Berlin-Buch Berlin
Germany Universitätsklinikum Carl Gustav Carus Dresden
Germany Universitätsklinikum Essen Essen
Germany Universitätsklinikum Hamburg-Eppendorf Hamburg
Germany Medizinische Hochschule Hannover Hannover
Germany University Medical Center Mannheim
Germany Klinikum der Universität München Campus Großhadern München

Sponsors (12)

Lead Sponsor Collaborator
Heidelberg University Hannover Medical School, Helios Klinikum Berlin-Buch, Klinikum der Universitaet Muenchen, Grosshadern, Medical University Innsbruck, Medical University of Graz, Medical University of Vienna, Novartis Pharmaceuticals, Universitätsklinikum Hamburg-Eppendorf, Universitätsmedizin Mannheim, University Hospital Dresden, University Hospital, Essen

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of Progression-free Survival The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions. 6 Month
Primary Rate of Progression-free Survival, Subgroup 1 Analysis Rate of progression-free survival for Subgroup 1 categorizing the 12 participants who showed PFS after 6 months into cutaneous angiosarcoma versus visceral angiosarcoma The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions. 6 months
Primary Rate of Progression-free Survival, Subgroup 2 Analysis Rate of progression-free survival for Subgroup 1 categorizing the 12 participants who showed PFS after 6 months into primary angiosarcoma versus secondary angiosarcoma.
The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.
6 months
Secondary Overall Survival Survival time of patient from start of treatment until death from start of treatment until death within study's actual observation time for OS (22 months).
Secondary Overall Survival, Subgroup 1 Analysis Survival time of patients from start of treatment until death, Subgroup 1 categorizing 26 overall participants into 18 cutaneous angiosarcoma versus 8 visceral angiosarcomas from start of treatment until death within study's actual observation time for OS (22 months)
Secondary Overall Survival, Subgroup 2 Analysis Survival time of patients from start of treatment until death, Subgroup 2 categorizing 26 overall participants into 13 primary cutaneous angiosarcoma versus 13 secondary angiosarcomas from start of treatment until death within study's actual observation time for OS (22 months)
Secondary Response Rate (RR) Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1.
RR is given as 'Best overall response" BOR" defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies
determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BOR
Secondary Response Rate (RR), Subgroup1 Analysis Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1.
RR is given as 'Best overall response" BOR" defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies for Subgroup 1 which is the analysis of cutaneous angiosarcoma versus visceral angiosarcoma
determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BOR
Secondary Response Rate (RR), Subgroup 2 Analysis Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1.
RR is given as 'Best overall response" BOR" defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies for Subgroup 2 which is the analysis of primary angiosarcoma versus secondary angiosarcoma
determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BOR
Secondary Adverse Events and Serious Adverse Events Number of patients in which adverse events occur during treatment according to Common Toxicity Criteria for Adverse Effects, Version 4.0 30 days after EOS of last patient or end of overall study observation period (22 months)
See also
  Status Clinical Trial Phase
Withdrawn NCT04906876 - A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas Phase 2
Completed NCT01303497 - Efficacity of Weekly Paclitaxel in Association or Not With Bevacizumab in Metastatic or Locally Advanced Angiosarcomas Phase 2
Recruiting NCT02625389 - Evaluation of Lipiodol® Ultra Fluid in Association With Surgical Glues During Vascular Embolization. Phase 4
Completed NCT04293289 - Boron Neutron Capture Therapy Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma N/A
Recruiting NCT05859074 - A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer Phase 1
Not yet recruiting NCT02732678 - Dose-Finding of Propranolol in Combination With Metronomic Fixed Oral Cyclophosphamide Based on Bivariate Efficacy-tolerability Outcome in Patients With Locally Advanced or Metastatic Angiosarcoma: A Collaborative and Innovative Phase I-II Sequential Trial by the French Sarcoma Group (GSF/GETO) Phase 1/Phase 2
Recruiting NCT04055220 - Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas N/A
Recruiting NCT06375941 - Prospective Observational Study of Localized Angiosarcoma of Any Site: ProStars
Recruiting NCT05799612 - Phase I Study of TH1 Dendritic Cell Immunotherapy for the Treatment of Cutaneous Angiosarcoma Phase 1
Withdrawn NCT05116800 - Phase 2 Study of 9-ING-41 With Chemotherapy in Sarcoma Phase 2
Recruiting NCT01042379 - I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer Phase 2
Active, not recruiting NCT01786889 - Identification, Molecular Epidemiology Angiosarcoma of the Liver France N/A
Active, not recruiting NCT02834013 - Nivolumab and Ipilimumab in Treating Patients With Rare Tumors Phase 2
Active, not recruiting NCT03331250 - Eribulin in Angiosarcoma and Epithelioid Hemangioendothelioma (EHE) Phase 2
Completed NCT02584309 - Doxorubicin With Upfront Dexrazoxane for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma Phase 2
Not yet recruiting NCT06277154 - MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma Phase 2
Withdrawn NCT04607200 - AGEN2034 & AGEN1884 in Patients With Recurrent, Inoperable Angiosarcoma Phase 2
Completed NCT04518124 - Propranolol in Angiosarcoma Phase 2
Recruiting NCT05961761 - Propranolol and Pembrolizumab in Advanced Soft Tissue Sarcoma Patients Phase 2
Completed NCT00887809 - Gemcitabine and Docetaxel With Bevacizumab in Selected Sarcoma Subtypes Phase 2