Pazopanib in Combination With Interferon Alfa 2-A, in Patients With Advanced Renal Cell Carcinoma

NCT01513187 | Completed Phase 1

• 1 other identifier: SOGUG-2010-01
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 13

Brief Summary

Phase I / II, open, prospective, multicenter single-arm, Clinical Trial in two stages: in the first stage it will determine the optimal dose of the combination of pazopanib and interferon alfa-A2 in the treatment of patients with advanced renal carcinoma and a second stage that will determine the efficacy of this combination measured in terms of response rate.

Conditions

Advanced Renal Cell Carcinoma

Keywords

Advanced renal cell carcinoma; SOGUG; Pazopanib; Pazopanib in combination with interferon alpha 2A

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD) - Phase I

  The MTD is defined as the dose at wich two of the patients have experienced dose-limiting toxicity.

  Up to September 2012

• Efficacy, response rate (Phase II)

  Response rate is defined as the percentage of patients with complete response or partial response confirmed according RECIST v.1.1

  Up to July 2013

Secondary Outcomes (4)

• Progression free survival

  Up to July 2013

• Overall Survival

  Up to December 2013

• Frequency of adverse events

  Up to July 2013

• Translational Substudy

  Up to December 2013

Study Arms (1)

Pazopanib + interferon

EXPERIMENTAL

Five levels of pazopanib in different doses: 400, 600 and 800 mg / day and interferon alfa 2-A 3, 6 and 9 MIU three times a week, in cycles of 28 days. Treatment will continue until disease progression, unacceptable toxicity, non-compliance or withdrawal of consent by the patient

Drug: Pazopanib + interferon alpha 2A

Interventions

Pazopanib + interferon alpha 2A DRUG

Five levels of pazopanib in different doses: 400, 600 and 800 mg / day and interferon alfa 2-A 3, 6 and 9 MIU three times a week, in cycles of 28 days. Treatment will continue until disease progression, unacceptable toxicity, non-compliance or withdrawal of consent by the patient

Pazopanib + interferon

Eligibility Criteria

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

You may qualify if:

• Signed informed consent
• Age ≥ 18 years.
• Patients diagnosed histologically clear cell carcinoma of the kidney metastatic or unresectable locally advanced, previously untreated. However, in Phase I may include patients with primary tumors other than renal cell can benefit from these drugs and patients with renal cell carcinoma treated before.
• Performance status (ECOG) 0-1.
• Patients must have measurable disease by RECIST criteria V 1.1. Progression should be documented in the two months prior to study entry.
• Patients may not have received prior treatment with anti-VEGF agents, mTOR inhibitors or cytokines. However, in Phase I may include patients who have received any previous treatment.
• Paraffin tumor sample should be available and collection of serum from all subjects for biomarker analysis previously and / or during treatment with study medication.
• Adequate Hematologic, liver and kidney functions.
• Able to swallow oral compound.
• Willingness and ability to attend scheduled visits, to follow the treatment schedule and to undergo clinical trials and other study procedures

You may not qualify if:

• History of prior malignancies diagnosed or treated over the past 5 years except basal cell skin cancer or prostate cancer incidentally detected previously treated. However, patients with a history of malignancy but free of the disease over the past 5 years, or patients with a history of nonmelanoma skin carcinoma-completely-resected or carcinoma in situ treated successfully can participate in the study .
• In Phase I, patients diagnosed with other previous or concomitant malignant diseases can be included.
• Presence of metastases in the central nervous system (CNS) or leptomeningeal carcinomatosis, except for patients with previously treated CNS metastases, asymptomatic and have not needed corticosteroids or anticonvulsant drugs in the 3 months prior to administering the first dose of the drug under study. Only is required CNS imaging studies (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) if clinically indicated or if the individual has a history of CNS metastases.
• Clinically significant gastrointestinal disorders may increase the risk of gastrointestinal bleeding including, but not limited to:
• Active peptic ulcer disease Known metastatic lesions with probable intraluminal bleeding Inflammatory bowel disease (ulcerative colitis, Crohn's disease) or other gastrointestinal disorders with increased risk of perforation History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days before the start of study treatment.
• Clinically significant gastrointestinal abnormalities may affect the absorption of the investigational product such as but not limited to:
• Malabsorption syndrome Major resection of the stomach or small intestine Grade 3 diarrhea
• Patients with active infection or other disease or serious medical condition.
• Prolongation of the corrected QT wave (QTc)\> 480 ms on baseline ECG according to the Bazett formula.
• Angioplasty or stent placement Myocardial infarction Unstable Angina Coronary bypass surgery Symptomatic peripheral vascular disease Congestive heart failure Class II, III or IV New York Heart Association (NYHA)
• Poorly controlled hypertension \[defined as systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure stress (DBP) ≥ 90 mmHg\] while the patient is on antihypertensive therapy.
• Note: the commencement or adjustment of antihypertensive medication it is possible before the patient study start. In the baseline period measure blood pressure at least twice with a minimum interval of 24 hours. The mean values of SBP / DBP in each blood pressure reading should be \<140/90 mmHg to include the subject in the study.
• Note: may be included subjects with recent DVT who received anticoagulants for at least 6 months.
• Evidence of active bleeding or bleeding diathesis.
• Pregnant or breastfeeding.

Sponsors & Collaborators

• Spanish Oncology Genito-Urinary Group: lead
• GlaxoSmithKline: collaborator

Study Sites (13)

Instituto Catalán de Oncología, Hospitalet del Llobregat

L'Hospitalet de Llobregat, Barcelona, 08097, Spain

Location

Centro Integral Oncológico Clara Campal

PAU de Sanchinarro, Sanchinarro - Madrid, 28050, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Clínic

Barcelona, 08036, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Central de Asturias

Oviedo, 33066, Spain

Location

Hospital Son Espases

Palma, 07010, Spain

Location

Clinica Univ. Navarra

Pamplona, 31008, Spain

Location

Hospital Virgen de la Macarena

Seville, 41009, Spain

Location

Hospital Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Virgen de la Salud

Toledo, 45004, Spain

Location

IVO

Valencia, 46009, Spain

Location

MeSH Terms

Interventions

pazopanib; Interferon alpha-2

Intervention Hierarchy (Ancestors)

Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Xavier García del Muro, MD

  Instituto Catalán de Oncología, Hospitalet del Llobregat

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2012
• First Posted: January 20, 2012
• Study Start: July 11, 2011
• Primary Completion: December 1, 2015
• Study Completion: February 22, 2019
• Last Updated: March 10, 2022

Record last verified: 2020-03

Locations

ES (13)