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Advanced Renal Cell CarcinomaPhase 1/2NCT01513187

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

A Phase 1/2 study testing Pazopanib + interferon alpha 2A in people with Advanced Renal Cell Carcinoma, run by Spanish Oncology Genito-Urinary Group at 13 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Renal Cell Carcinoma
What is being tested?
Pazopanib + interferon alpha 2A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
13 sitesSpain
Study dates
11 Jul 2011to 22 Feb 2019
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Women of childbearing potential must be using an effective method of birth control (abstinence, any intrauterine device [IUD] published data showing that the expected minimum rate of failure is less than 1% per year, or any other method the published data show that the expected minimum rate of failure is less than 1% per year) before inclusion in the study and continue using it during the same six months after completion. Women of childbearing age should get a negative pregnancy test in urine or serum (minimum sensitivity 25 IU / L or equivalent units of beta fraction of human chorionic gonadotropin [β-HCG]) during the seven days prior to the randomization.
  • 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

Who cannot join

  • 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:
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  • 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.
  • Subjects with a history of one or more of the following cardiovascular disease in the last 6 months prior to the inclusion in the study:
  • 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.
  • Background, in the last six months prior to the inclusion of stroke (including transient ischemic attacks), pulmonary embolism or deep vein thrombosis (DVT) untreated.
  • Note: may be included subjects with recent DVT who received anticoagulants for at least 6 months.
  • Surgery or trauma in the last 28 days, or minor surgery (eg., Removal of central venous catheter) in the last 7 days prior to inclusion or unhealed wound, fracture, or ulcer.
  • Evidence of active bleeding or bleeding diathesis.
  • Hemoptysis within 6 weeks prior to inclusion.
  • Pregnant or breastfeeding.
  • Any medical condition (eg. Uncontrolled infection), psychiatric or other to be serious and / or unstable and may interfere with the safety of the patient, obtaining informed consent or compliance with study procedures.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Spain13 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Clínic

    Barcelona, 08036

  • Instituto Catalán de Oncología, Hospitalet del Llobregat

    L'Hospitalet de Llobregat, Barcelona, 08097

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Central de Asturias

    Oviedo, 33066

  • Hospital Son Espases

    Palma, 07010

  • Clinica Univ. Navarra

    Pamplona, 31008

  • Centro Integral Oncológico Clara Campal

    PAU de Sanchinarro, Sanchinarro - Madrid, 28050

  • Hospital Virgen de la Macarena

    Seville, 41009

  • Hospital Virgen del Rocio

    Seville, 41013

  • Hospital Virgen de la Salud

    Toledo, 45004

  • IVO

    Valencia, 46009

Other trials in Spain

About this study

Official title: Phase I/II Prospective, Open Label and Multicentric Clinical Trial to Determine the Recommended Dose (Phase I) and Efficacy of Pazopanib in Combination With Interferon Alfa 2-A (Phase II), in Patients With Advanced Renal Cell Carcinoma

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.

Being tested
Pazopanib + interferon alpha 2A
Keywords
Advanced renal cell carcinoma, SOGUG, Pazopanib, Pazopanib in combination with interferon alpha 2A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pazopanib + interferon alpha 2ADrug

    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

Study groups in NCT01513187
Study groupRoleWhat they receive
Pazopanib + interferonExperimentalFive 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
Receives: Drug: Pazopanib + interferon alpha 2A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD) - Phase I

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

    Measured: Up to September 2012

  2. 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

    Measured: Up to July 2013

Secondary outcomes (4)

  1. Progression free survival

    Period between the start of treatment until the day in in wich the progression is confirmed by RECIST guidelines (version 1.1) or death from any cause.

    Measured: Up to July 2013

  2. Overall Survival

    Period between the start of treatment and date of death from any cause.

    Measured: Up to December 2013

  3. Frequency of adverse events

    Toxicity evaluation of the combination using the NCI-CTC Criteria version 3.0

    Measured: Up to July 2013

  4. Translational Substudy

    To analyze the different biomarkers and their variations with clinical outcomes of patients.

    Measured: Up to December 2013

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2012 (estimated)
  2. Study start11 Jul 2011
  3. Primary completionDec 2015
  4. Study completion22 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01513187
Sponsor's protocol ID
SOGUG-2010-01
Status last verified
Mar 2020
First submitted
10 Jan 2012
Last updated
10 Mar 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pazopanib + interferon alpha 2A in people with Advanced Renal Cell Carcinoma, run by Spanish Oncology Genito-Urinary Group at 13 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) - Phase I (time frame: Up to September 2012). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01513187.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.

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