Pazopanib Vs. Pazopanib Plus Gemcitabine

NCT02203760 | Active Not Recruiting Phase 2

• 2 other identifiers: NOGGO U12012-003810-15
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 9

Brief Summary

This study is a prospective, randomized, open-label, multicenter phase II trial in order to determine progression-free survival of patients with refractory or relapsed metastatic uterine leiomyosarcomas or other metastatic uterine tumours.

Conditions

Leiomyosarcoma or Carcinosarcoma

Keywords

Relapsed/metastatic uterine leiomyosarcomas/carcinosarcomas

Outcome Measures

Primary Outcomes (1)

• Progression free survival assessed as rate of patients without progression Second malignancy or clinical progression - patients with unknown or missing PFS will be treated as non-responder

  6 months

Secondary Outcomes (6)

• Objective response rate (RECIST v1.1 criteria)

  One year

• Objective response rate (RECIST v1.1 criteria)

  One year

• Objective response rate (RECIST v1.1 criteria)

  one year

• Safety - side effects

  One year

• Quality of life (EORTC QLQ-C30)

  One year

Study Arms (2)

Pazopanib plus Gemcitabine

EXPERIMENTAL

Arm A: Pazopanib 800 mg orally once daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d 1 and d 8 q3w or

Drug: Pazopanib plus Gemcitabine

Pazopanib

ACTIVE COMPARATOR

Pazopanib 800 mg orally once daily

Drug: Pazopanib

Interventions

Pazopanib plus Gemcitabine DRUG

Pazopanib 800 mg orally once daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d 1 and d 8 q3w or

Also known as: Votrient and Gemzar

Pazopanib plus Gemcitabine

Pazopanib DRUG

Pazopanib 800 mg orally once daily

Also known as: Votrient

Pazopanib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must provide informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up. Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol
• Histologically or cytological confirmed uterine leiomyosarcoma or uterine carcinosarcoma including any subtypes
• Patients with a contraindication for doxorubicin OR patients must have received prior chemotherapies
• For patients with prior anthracycline therapy normal cardiac function with LVEF at least 50% must be assessed by quantitative echocardiogram or MUGA scan
• Prior Gemcitabine containing chemotherapy is permitted provided that at least 8 weeks have elapsed since the last dose of therapy
• ECOG performance status 0-1
• At least 18 years old
• Measurable disease according to RECIST v 1.1 criteria (in case of tumour debulking - staging CT-scan after surgery)
• Able to swallow and retain oral medication
• Adequate organ system function as defined in Table 1
• Table 1: Definitions for Adequate Organ Function System Laboratory Values Hematologic Absolute neutrophil count (ANC) \> = 1.5 X 109/L Hemoglobin1 \> = 9 g/dL (5.6 mmol/L) Platelets \> = 100 X 109/L Prothrombin time (PT) or international normalized ratio (INR)4 \<= 1.2 X upper limit of normal (ULN) Partial thromboplastin time (PTT) \<=1.2 X ULN Hepatic2 Total bilirubin \<= 1.5 X ULN AST and ALT \<= 2.5 X ULN Renal Serum creatinine \<= 1.5 mg/dL (133 µmol/L)
• Or, if greater than 1.5 mg/dL:
• Calculated creatinine clearance \> = 50 mL/min
• Urine Protein to Creatinine Ratio (UPC)3 \< 1
• Subjects may not have had a transfusion within 7 days prior to screening assessment.

You may not qualify if:

• Prior malignancy
• Note: Subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
• Patient has received prior treatment with any anti-angiogenic agent including bevacizumab and tyrosine kinase inhibitors
• Active malignancy or any malignancy in the last 5 years prior to first dose of study drug other than LMS and CS
• History or clinical evidence of central nervous system (CNS) or leptomeningeal metastases, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug. Screening with CNS imaging studies (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) is required only if clinically indicated or if the subject has a history of CNS metastases
• Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
• Active peptic ulcer disease
• Known intraluminal metastatic lesion/s with risk of bleeding
• Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment
• Grade 3/4 diarrhea
• Corrected QT interval (QTc) \> 450 Milliseconds using Barzett's formula
• History of any one or more of the following cardiovascular conditions within the past 6 months:
• Cardiac angioplasty or stenting
• Myocardial infarction

Sponsors & Collaborators

• North Eastern German Society of Gynaecological Oncology: lead
• Novartis Pharmaceuticals: collaborator
• medac GmbH: collaborator

Study Sites (9)

Universitätsklinikum Bonn

Bonn, Bonn, 53127, Germany

Location

Helios Klinikum Berlin-Buch, Klinik für Onkologie und Paliativmedizin

Berlin, Germany, 13125, Germany

Location

Universitätsmedizin Greifswald Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe

Greifswald, Greifswald, 17475, Germany

Location

Helios Klinikum Bad Saarow, Hämatologie, Onkologie und Palliativmedizin, Sarkomzentrum

Bad Saarow, 15526, Germany

Location

Universitätsmedizin Berlin Charité Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden Klinik für Frauenheilkunde und Geburtshilfe

Dresden, 01807, Germany

Location

Kliniken-Essen-Mitte Evang. Huyssens-Stiftung Klinik für Senologie / Brustzentrum

Essen, 45136, Germany

Location

Universitätsklinikum Jena

Jena, 07747, Germany

Location

Universitätsfrauenklinik Tübingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Leiomyosarcoma; Carcinosarcoma; Recurrence

Interventions

pazopanib; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neoplasms, Complex and Mixed; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Alexander Mustea, Prof. Dr. med.

  University Hospital, Bonn

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: July 30, 2014
• Study Start: October 16, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

DE (9)