Pazopanib Maintenance Phase II

NCT02207309 | Terminated Phase 2 Results

• 2 other identifiers: NPM0012013-000522-58
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This trial compares pazopanib to placebo as maintenance treatment over 2 years in patients with retroperitoneal and visceral high-risk soft tissue sarcomas after multimodal treatment including prior neo- and/or adjuvant doxorubicin / ifosfamide chemotherapy with regional hyperthermia.

Conditions

Sarcoma

Keywords

high-risk soft tissue sarcoma; pazopanib; retroperitoneal soft tissue sarcoma; visceral soft tissue sarcoma; votrient

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  The study could not be evaluated. Only one patient was included.

  Study Start Dat: June 22, 2015; Study Completion Date: July 29, 2016 ; an approximate study duration of 13 months

Secondary Outcomes (1)

• Overall Survival (OS)

  Study Start Dat: June 22, 2015; Study Completion Date: July 29, 2016 ; an approximate study duration of 13 months

Study Arms (2)

Pazopanib

ACTIVE COMPARATOR

800mg, oral, 24 months

Drug: Pazopanib

Placebo

PLACEBO COMPARATOR

800mg, oral, 24 months

Drug: Placebo (for Pazopanib)

Interventions

Pazopanib DRUG

Also known as: Votrient

Pazopanib

Placebo (for Pazopanib) DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• 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
• Patients must have histological evidence of high-grade soft tissue sarcoma (grade 2 - 3) according to the FNLCC grading system, tumor size ≥ 5 cm and deep localization with regard to the superficial fascia, excluding the following tumor types:
• Embryonal rhabdomyosarcoma
• Chondrosarcoma (excluding extraskeletal myxoid chondrosarcoma)
• Osteosarcoma (excluding extraskeletal osteosarcoma)
• Ewing tumors / primitive neuroectodermal tumor (PNET)
• Gastro-intestinal stromal tumors (GIST)
• Dermatofibrosarcoma protuberans
• Patients who had undergone previous surgery with inadequate margins (tumour-free margins ≤1 cm or margins contaminated) are eligible if thermochemotherapy has been started within 8 weeks after surgery
• Unstained slides and ideally tumour blocks must be available for histological central review
• Completed 4 to 8 cycles of thermochemotherapy with doxorubicin and ifosfamide at least 21 days but no more than 42 days prior to study entry
• No evidence of disease following completion of first-line thermochemotherapy and within ≤ 21 days of study entry
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• No other prior chemotherapy except thermochemotherapy with doxorubicin and ifosfamide
• Adequate organ system function

You may not qualify if:

• No prior or concurrent second primary malignant tumors (except adequately treated in situ carcinoma of cervix, or basal cell carcinoma)
• No symptomatic or known Central nervous system (CNS) metastases at baseline
• 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, Chrohn'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.
• Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
• Malabsorption syndrome
• Major resection of the stomach or small bowel.
• Corrected QT interval (QTc) \> 480 msecs
• History of any one or more of the following cardiovascular conditions within the past 6 months:
• Cardiac angioplasty or stenting
• Myocardial infarction
• Unstable angina

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Ludwig-Maximilians University of Munich, Klinikum Großhadern

Munich, Bavaria, 81377, Germany

Location

MeSH Terms

Conditions

Sarcoma

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Lars Lindner
• Organization: Ludwigs-Maximilians-Universtity of Munich

Lars.Lindner@med.uni-muenchen.de

0049894400

Study Officials

• Lars Lindner, MD, PhD

  Ludwig-Maximilians - University of Munich

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 4, 2014
• Study Start: June 22, 2015
• Primary Completion: July 29, 2016
• Study Completion: July 29, 2016
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-02

Locations

DE (1)