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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT00420888
• Date of registration: 09/01/2007
• Prospective Registration: No
• Primary sponsor: Active Biotech AB
• Public title: ABR-217620/Naptumomab Estafenatox With Interferon-alpha (IFN-alpha) Compared to IFN-alpha Alone in Patients With Advanced Renal Cell Carcinoma
• Scientific 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.
• Date of first enrolment: January 2007
• Target sample size: 526
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00420888
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

Bulgaria, Norway, Romania, Russian Federation, Ukraine, United Kingdom

Contacts

• Name: Thore Nederman, PhD
• Affiliation: Active Biotech AB

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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.

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Renal Cell Carcinoma

Intervention(s)

Drug: ABR-217620/naptumomab estafenatox

Drug: IFN-alpha

Primary Outcome(s)

Time to death [Time Frame: every 12 weeks, including after a maximum of 18 months of study treatment]

Secondary Outcome(s)

Objective tumor response rate [Time Frame: every 12 weeks for the 18-month treatment period]

Immunological response in patients on combined treatment of ABR-217620/naptumomab estafenatox and IFN-alpha [Time Frame: Weeks 1, 9, 17, 25, 73]

Pharmacokinetic parameters of ABR-217620/naptumomab estafenatox [Time Frame: Weeks 1, 9, and 17]

Progression-free survival time [Time Frame: every 12 weeks for the 18-month treatment period and also every 12 weeks after the treatment period]

Changes in sum of target lesions [Time Frame: every 12 weeks for the 18-month treatment period]

Vital signs [Time Frame: every visit through Week 25, plus Week 73]

Best overall response [Time Frame: every 12 weeks for the 18-month treatment period]

Physical measurements [Time Frame: Weeks 1, 9, 17, 25, 73]

Duration of response [Time Frame: every 12 weeks for the 18-month treatment period]

Laboratory safety assessments [Time Frame: Weeks 1, 2, 3, 5, 9, 10, 13, 17, 18, 21, 25, and 73]

Adverse events [Time Frame: every visit through Week 73]

Secondary ID(s)

06762004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors