Pazopanib in Second-line Therapy in Renal Cell Carcinoma

NCT01577784 | Unknown Phase 2

• 1 other identifier: APRO02-2011
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 10

Brief Summary

The principal aim of the study is to determine the objective response rate that offers the second-line treatment with pazopanib in patients with carcinoma of advanced renal cells that have progressed or that have not tolerated the first line of treatment with a Tyrosine Kinase Inhibitor. The secondary aims are to determine the overall survival and the treatment safety profile for these patients in second-line treatment with pazopanib. The exploratory aim is to determine the correlation between biomarkers in patient blood and tumor samples, and the clinical results obtained with pazopanib.

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Advanced renal cell carcinoma; second-line treatment with pazopanib; first line of treatment with a Tyrosine Kinase Inhibitor

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  To asses the Objective Response (Complete Response or Partial Response) which provides second-line treatment with pazopanib in patients with carcinoma of advanced renal cell who have progressed or have not tolerated a first line of treatment with a Tyrosine Kinase Inhibitor. The Objective Response Rate will be evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  30 months

Secondary Outcomes (2)

• Overall Survival

  30 months

• Treatment Safety Profile

  30 months

Study Arms (1)

Pazopanib

EXPERIMENTAL

800 mg / day of pazopanib in monotherapy

Drug: Pazopanib

Interventions

Pazopanib DRUG

800 mg / day of pazopanib in monotherapy.

Also known as: Pazopanib (GW786034; Votrient®)

Pazopanib

Eligibility Criteria

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

You may qualify if:

• Signed Inform Consent
• Age ≥ 18
• Histologically confirmed diagnosis of clear cell renal carcinoma metastatic or locally recurrent unresectable.
• Patients must have received only a first-line treatment with a Tyrosine Kinase Inhibitor. Patients must have progressed during treatment or within three months after stopping treatment with these agents. Patients who discontinued treatment with a Tyrosine Kinase Inhibitor for unacceptable toxicity are also eligible for the study.
• Patients must have been previously treated by nephrectomy with removal of the primary tumor, except that there is a contraindication (eg liver I extensive bone metastatic disease or primary tumor smaller than 5 cm).
• Patients with ECOG PS 0 or 1.
• To be included in the study, the renal tumor should be classified in a group of low or intermediate risk according to the Motzer classification.
• Eligibility criteria under RECIST v.1.1
• Adequate hematologic function:
• Absolute neutrophil count ≥ 1.5 x 109 / L Platelet count ≥ 100 x 109 / L Hemoglobin ≥ 9 g / dL (5.6 mmol / L). Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.2 X ULN. Activated partial thromboplastin time (APTT) ≤ 1.2 X ULN
• Adequate hepatic function:
• total bilirubin ≤ 1.5 X ULN ALT ≤ 2.5 x ULN
• Adequate renal function:
• Serum creatinine ≤ or 1.5 mg / dL (133 mol / L). If\> 1.5 mg / dL, then the calculated creatinine clearance has to be ≥ 50 mL / min (Appendix 1).
• Urine protein / creatinine ratio \<1.

You may not qualify if:

• Previous treatment with more then one Tyrosine Kinase Inhibitor or more than one previous traditional regime (eg, chemotherapy, immunotherapy or chemo-immunotherapy).
• Known history or clinical evidence of nervous system metastases or leptomeningeal carcinomatosis, except that metastases in the central nervous system have been previously treated, are asymptomatic and not requiring treatment with corticosteroids or anticonvulsant medication within six months before the first administration of pazopanib.
• Clinically significant gastrointestinal disorders that may increase the risk of bleeding gastrointestinal.
• Clinically significant gastrointestinal disorders which may affect the absorption of pazopanib.
• Presence of uncontrolled infection.
• ECG QT interval longer than 480 milliseconds, according to the Bazett formula.
• Cardiac angioplasty or stent placement Myocardial infarction Unstable angina Surgery or coronary bypass Symptomatic peripheral vascular disease
• Congestive heart failure Class III or IV, as defined by the New York Heart Association
• Poorly controlled hypertension (defined as systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).
• History of stroke (including transient ischemic attack), pulmonary embolism or deep vein thrombosis not treated within 6 months.
• Major surgery or major trauma within 28 days prior to administering the first dose of study and / or presence of any unhealed wound, fracture, or ulcer (not considered major procedures such as venous catheter placement with or without a reservoir).
• Evidence of bleeding diathesis or active bleeding.
• Endobronchial lesions known and / or lesions infiltrating major pulmonary vessels.
• Hemoptysis greater than 2.5 milliliters in the 8 weeks before the first administration of study drug.
• Any medical condition, psychiatric or any other nature, unstable or severe, which could interfere with patient safety, with the ability to give informed consent or compliance with study procedures.

Sponsors & Collaborators

• Associació per a la Recerca Oncologica, Spain: lead
• Trial Form Support S.L.: collaborator

Study Sites (10)

Hospital Universitari Son Espases

Palma de Mallorca, Balearic Islands, 07010, Spain

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Corporació Sanitaria Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, 28009, Spain

Location

Hospital 12 de Octubre

Madrid, Madrid, 28026, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33006, Spain

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Joaquim Bellmunt, MD

  Hospital del Mar

  STUDY CHAIR

• Marta Guix, MD

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

• Juan Manuel Sepúlveda, MD

  Hospital 12 de Octubre

  PRINCIPAL INVESTIGATOR

• Enrique Gallardo, MD

  Corporació Sanitaria Parc Taulí

  PRINCIPAL INVESTIGATOR

• Xavier García del Muro, MD

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

• Olatz Etxaniz, MD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

• José Luis González Larriba, MD

  Hospital San Carlos, Madrid

  PRINCIPAL INVESTIGATOR

• Jose Angel Arranz, MD

  Hospital General Universitario Gregorio Marañón

  PRINCIPAL INVESTIGATOR

• Emilio Esteban, MD

  Hospital Universitario Central de Asturias

  PRINCIPAL INVESTIGATOR

• Aranzazu González del Alba, MD

  Hospital Son Espases

  PRINCIPAL INVESTIGATOR

• Pablo Maroto, MD

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 16, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2015
• Last Updated: March 12, 2014

Record last verified: 2014-03

Locations

ES (10)