AzTrials
AzTrials

Renal Cell CarcinomaPhase 2/3NCT00420888

ABR-217620/Naptumomab Estafenatox With Interferon-alpha (IFN-alpha) Compared to IFN-alpha Alone in Patients With Advanced Renal Cell Carcinoma

A Phase 2/3 study testing ABR-217620/naptumomab estafenatox and IFN-alpha in people with Renal Cell Carcinoma, run by Active Biotech AB at 51 sites in 5 countries.

Completed

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

Official record
Search all trials

Trial summary

The drug ABR-217620/naptumomab estafenatox is a fusion of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body's normal immune system. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
ABR-217620/naptumomab estafenatox and IFN-alpha
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
526 participants
Where
51 sitesin 5 countries
Study dates
Jan 2007to Jan 2013
Phase
Phase 2/3
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

  • Histologically or cytologically confirmed RCC (clear cell and papillary types)
  • Metastatic or inoperable locally advanced RCC
  • Eligible for therapy with IFN-alpha.
  • Measurable disease defined by at least 1 measurable lesion on CT scan (lesion diameter greater than or equal to 2.0 cm by a standard CT scanner or greater than or equal to 1.0 cm by a spiral CT scanner)
  • Favorable or moderate risk group prognosis by MSKCC (Motzer) criteria (score 0-2)
  • Karnofsky performance status greater than or equal to 70
Show all 19Show fewer
  • Age greater than or equal to 18
  • Life expectancy greater than 3 months
  • Baseline blood counts:
  • Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L
  • Platelets greater than or equal to 100 x 10^9/L
  • Haemoglobin greater than or equal to 100 g/L
  • Baseline blood chemistry levels:
  • Creatinine less than or equal to 1.5 x upper limit of normal (ULN)
  • Bilirubin less than or equal to 2 x ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN. AST and ALT allowed less than or equal to 5 x ULN for patients with liver metastases.
  • If fertile, patient will use effective method of contraception throughout the study
  • Willing and able to comply with the treatment and follow-up visits and examinations
  • Capable of understanding the parameters in the protocol and able to sign a written consent form

Who cannot join

  • Pregnant or breastfeeding women
  • Serious uncontrolled medical disorder or active infection ongoing or resolved within 2 weeks before first dose of study drug and that the investigator believes would impair the patient's ability to receive study drug
  • History of malignancy within 5 years or concurrent malignancy, except successfully treated non-melanoma skin cancer, cervical cancer in situ, ductal carcinoma in situ or lobular carcinoma in situ of breast may be included
  • History and/or signs of parenchymal brain metastases
  • Significant cardiac disease including: history (within 6 months) or current unstable angina pectoris, congestive heart failure (NYHA stage III-IV), myocardial infarction within 12 months, or uncontrolled arterial hypertension.
  • History of stroke within 5 years and/or transient ischemic attack within 6 months.
Show all 21Show fewer
  • Acute illness or evidence of infection, including unexplained fever (>100.5ºF or 38.1ºC) within 2 weeks before start of treatment
  • Treatment with biological response modifiers within 3 weeks prior to the start of treatment and up to the End-of-Study visit
  • Treatment with beta-blockers, including topical therapy for glaucoma, within 5 days before start of treatment and during the 4-day ABR-217620/naptumomab estafenatox treatment
  • Treatment with systemic corticosteroids within 2 weeks before start of treatment or likely need for such treatment during the study
  • Active autoimmune disease requiring therapy or any history of systemic lupus erythematosus or rheumatoid arthritis
  • Known positive serology for HIV
  • Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of chronic virus hepatitis or known virus carrying; patients who recovered from Hepatitis A are allowed
  • Treatment with anticoagulants within 2 weeks before start of treatment, except when used to maintain the patency of a central or peripheral venous line
  • Radiotherapy less than 4 weeks before start of treatment
  • Major surgery or tumor embolization less than 4 weeks before start of treatment
  • Previous exposure to murine monoclonal antibodies or known hypersensitivity to murine proteins
  • Currently on renal dialysis treatment
  • Known allergy or hypersensitivity to aminoglycosides and kanamycin
  • Previous systemic anti-tumor therapy for RCC (including immunotherapy with IFN-alpha or IL-2 or any chemotherapy) except sunitinib or other oral antiangiogenic therapy
  • Participation in any study with investigational drugs for RCC within 6 weeks

Trial locations and contacts

51 sites in 5 countries.

51 sites in 5 countries

Russia19 sites

  • Arkhangelsk Regional Oncology Center

    Arkhangelsk

  • Chelyabinsk Regional Oncology Center

    Chelyabinsk, 454087

  • Republican Clinical Oncology Center

    Kazan', 420029

  • Kazan City Oncology Center

    Kazan', 420111

  • Research Institute of Urology

    Moscow, 105425

  • Russian Oncological Research Center n.a. N.N. Blokhin

    Moscow, 115478

  • Russian Research Center of Radiology

    Moscow, 117997

  • Medical Radiology Research Center

    Obninsk, 249036

  • Orenburg Regional Clinical Oncology Center

    Orenburg, 460021

  • Leningrad Regional Oncological Center

    Saint Petersburg, 191104

  • Municipal Aleksandrovskaya Hospital

    Saint Petersburg, 193312

  • Municipal Multi-Speciality Hospital #2

    Saint Petersburg, 194354

  • Municipal Hospital #26

    Saint Petersburg, 196247

  • Municipal Clinical Oncology Center

    Saint Petersburg, 197022

  • Central Research Institute of Roentgenology and Radiology

    Saint Petersburg, 197758

  • Research Institute of Oncology n.a. Professor N.N. Petrov

    Saint Petersburg, 197758

  • Municipal Hospital #15

    Saint Petersburg, 198205

  • Stavropol Territorial Clinical Oncology Center

    Stavropol, 355047

  • Regional Clinical Oncology Hospital

    Yaroslavl, 150054

Other trials in Russia

Ukraine11 sites

  • Cherkassy Regional Oncology Center

    Cherkassy, 18009

  • Chernigov Regional Oncology Center

    Chernihiv, 14029

  • Urology Department, Dnepropetrovsk State Medical Academy

    Dnipro, 49005

  • City General Hospital #4

    Dnipro, 49102

  • Donetsk Regional Antitumor Center

    Donetsk, 83092

  • Ivano-Frankovsk Regional Oncology Center

    Ivano-Frankivsk, 76000

  • Kharkiv Regional Urology and Nephrology Center

    Kharkiv, 61037

  • Institute of Urology under the Academy of Medical Sciences of Ukraine, Department of Plastic and Supportive Urology

    Kiev, 04053

  • Institute of Urology under the Academy of Medical Sciences of Ukraine, Urology Department

    Kiev, 04053

  • State Regional Diagnostics and Treatment Oncology Center

    Lviv, 79031

  • Regional Oncology Center

    Uzhhorod, 88014

Other trials in Ukraine

Romania8 sites

  • Fundeni Clinical Institute - Urology Department

    Bucharest, 022328

  • Dinu Uromedica

    Bucharest, 041345

  • "Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic

    Bucharest, 050659

  • "I. Chiricuta" Institute of Oncology

    Cluj-Napoca, 400015

  • E-URO Medical Center

    Cluj-Napoca, 400016

  • Provita Center SRL

    Constanța, 900635

  • Sibiu Clinical Country Hospital - Urology Clinic

    Sibiu, 550245

  • Oncomed SRL

    Timișoara, 300239

Other trials in Romania

United Kingdom7 sites

  • Addenbrooke's Hospital, Cambridge Clinical Trials Centre

    Cambridge, CB2 0QQ

  • Derby Hospital NHS Trust

    Derby, DE1 2QY

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • St. James's Institute of Oncology

    Leeds, LS9 7TF

  • The Royal Marsden NHS Trust

    London, SW6 6JJ

  • The Christie Hospital NHS Trust

    Manchester, M20 4BX

  • South Wales Cancer Institute, Singleton Hospital

    Swansea, SA2 8QA

Other trials in United Kingdom

Bulgaria6 sites

  • Department of Chemotherapy, University General Hospital for Active Treatment "Georgi Stranski"

    Pleven, 5800

  • 1st Internal Department District Dispensary for Cancer Diseases with Inpatient Hospital

    Plovdiv, 4004

  • Multifile Hospital "Aleksandrovska", Urology Clinic, Department of Oncourology

    Sofia, 1431

  • Oncology Clinic, University General Hospital for Active Treatment "Tzaritza Yoanna"

    Sofia, 1527

  • Urology Clinic, General Hospital for Active Treatment "St. Anna"

    Varna, 9002

  • Department of Chemotherapy, Inter-district Dispensary for Cancer Diseases with Inpatient Hospital

    Veliko Tarnovo, 5000

Other trials in Bulgaria

About this study

Official title: A Randomized, Open-label, Multi-center, Phase II/III Study on Treatment With ABR-217620/Naptumomab Estafenatox Combined With IFN-alpha vs. IFN-alpha Alone in Patients With Advanced Renal Cell Carcinoma.

The drug ABR-217620/naptumomab estafenatox is a fusion of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body's normal immune system. This results in an accumulation of white blood cells in the cancer that can fight the cancer. This study will compare the safety and effectiveness (assessed by tumor status and survival) of ABR-217620/naptumomab estafenatox when given with standard therapy IFN-alpha to IFN-alpha alone in patients with advanced renal cell carcinoma (RCC).

Being tested
ABR-217620/naptumomab estafenatox, IFN-alpha
Medical subject headings
Carcinoma, Renal Cell

What participants receive

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

  • ABR-217620/naptumomab estafenatoxDrug

    Also called naptumomab estafenatox

    10 mcg/kg or 15 mcg/kg, 5 minute bolus intravenous injection on 4 consecutive days / 8 week cycle repeated 3 times

  • IFN-alphaDrug

    Also called Referon-A

    3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week

Study groups in NCT00420888
Study groupRoleWhat they receive
Safety groupExperimental6-12 patients
Receives: Drug: ABR-217620/naptumomab estafenatox; Drug: IFN-alpha
1ExperimentalNot described
Receives: Drug: ABR-217620/naptumomab estafenatox; Drug: IFN-alpha
2OtherStandard treatment with IFN-alpha without add-on of ABR-217620/naptumomab estafenatox
Receives: Drug: IFN-alpha

What is being measured

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

  1. Time to death

    Measured: every 12 weeks, including after a maximum of 18 months of study treatment

Secondary outcomes (11)

  1. Progression-free survival time

    Measured: every 12 weeks for the 18-month treatment period and also every 12 weeks after the treatment period

  2. Objective tumor response rate

    Measured: every 12 weeks for the 18-month treatment period

  3. Best overall response

    Measured: every 12 weeks for the 18-month treatment period

  4. Duration of response

    Measured: every 12 weeks for the 18-month treatment period

  5. Changes in sum of target lesions

    Measured: every 12 weeks for the 18-month treatment period

  6. Immunological response in patients on combined treatment of ABR-217620/naptumomab estafenatox and IFN-alpha

    Measured: Weeks 1, 9, 17, 25, 73

  7. Vital signs

    Measured: every visit through Week 25, plus Week 73

  8. Physical measurements

    Measured: Weeks 1, 9, 17, 25, 73

  9. Adverse events

    Measured: every visit through Week 73

  10. Laboratory safety assessments

    Measured: Weeks 1, 2, 3, 5, 9, 10, 13, 17, 18, 21, 25, and 73

  11. Pharmacokinetic parameters of ABR-217620/naptumomab estafenatox

    Measured: Weeks 1, 9, and 17

Timeline

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

  1. First posted11 Jan 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionJan 2013
  4. Study completionJan 2013

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
526 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00420888
Sponsor's protocol ID
06762004
Status last verified
Jun 2014
First submitted
9 Jan 2007
Last updated
22 Jul 2015
Results posted
No
Data monitoring committee
No

Publications

  • Hawkins R, Gore M, Shparyk Y, Bondar V, Gladkov O, Ganev T, Harza M, Polenkov S, Bondarenko I, Karlov P, Karyakin O, Khasanov R, Hedlund G, Forsberg G, Nordle Ö, Eisen T. A randomized phase 2/3 study of naptumomab estafenatox plus IFN-α vs IFN-α in advanced renal cell carcinoma. ASCO Annual Meeting 2013; Abstract ID: 3073.

  • Eisen T, Hedlund G, Forsberg G, Nordle Ö, Hawkins R. Baseline biomarker trend analysis of a randomized phase 2/3 study of naptumomab estafenatox plus IFN-α vs IFN-α in advanced renal cell carcinoma. European Cancer Congress (ECCO) 2013; Abstract ID: 2710.

  • Elkord E, Burt DJ, Sundstedt A, Nordle O, Hedlund G, Hawkins RE. Immunological response and overall survival in a subset of advanced renal cell carcinoma patients from a randomized phase 2/3 study of naptumomab estafenatox plus IFN-alpha versus IFN-alpha. Oncotarget. 2015 Feb 28;6(6):4428-39. doi: 10.18632/oncotarget.2922.

    PubMed 25669986

  • Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.

    PubMed 37146227

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing ABR-217620/naptumomab estafenatox and IFN-alpha in people with Renal Cell Carcinoma, run by Active Biotech AB at 51 sites in 5 countries.

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 19 inclusion and 21 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 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in Russia, Ukraine, Romania, United Kingdom, Bulgaria. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Time to death (time frame: every 12 weeks, including after a maximum of 18 months of study treatment). 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 NCT00420888, which also lists 4 linked publications.

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 22 Jul 2015; AzTrials last refreshed its copy on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in