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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00520533




Registration number
NCT00520533
Ethics application status
Date submitted
22/08/2007
Date registered
24/08/2007

Titles & IDs
Public title
Study of Safety and Functional Imaging of cG250 and Sunitinib in Patients With Advanced Renal Cell Carcinoma
Scientific title
A Pilot Study of the Safety, Efficacy, and Effects on Functional Imaging of the Combination of cG250 and Sunitinib in Patients With Advanced Renal Cell Carcinoma
Secondary ID [1] 0 0
LUD2007-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma (RCC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Chimeric monoclonal antibody cG250
Treatment: Drugs - Sunitinib malate

Experimental: On Study - Treatment (cycle 1):

* cG250 10mg/m² IV weekly x 5 doses (1st \& 5th doses trace-labelled with 124I)
* Sunitinib 50 mg/day orally x 4 weeks commencing day 8
* Followed by two-week break

Treatment (cycle 2 - investigator discretion):

* cG250 10mg/m² IV weekly x4 doses
* Sunitinib 50 mg/day orally x 4 weeks (commencing concurrently)
* Followed by two-week break


Treatment: Other: Chimeric monoclonal antibody cG250
First Cycle: cG250 10 mg/m² intravenous infusion, weekly for five weeks, followed by a two-week break. 1st \& 5th dose will be trace-labeled with a radioactive substance detectable on a PET scanner (124I-cG250).

Second cycle (investigator discretion): cG250 10 mg/m² intravenous infusion, weekly for four weeks followed by a two-week break. No 124I-cG250 will be used in the 2nd cycle.

Up to 2 cycles available.

Treatment: Drugs: Sunitinib malate
First Cycle: Sunitinib 50 mg orally daily for 4 weeks (starts 8th day of 1st treatment cycle), followed by a two-week period off sunitinib.

Second cycle (investigator discretion): Sunitinib 50 mg orally daily for 4 weeks (starts on 1st day of 2nd treatment cycle), followed by a two-week period off sunitinib.

Up to 2 cycles available on-study.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs), Dose Limiting Toxicities (DLTs) or Adverse Events Leading to Discontinuation.
Timepoint [1] 0 0
up to 14 weeks
Secondary outcome [1] 0 0
Number of Patients With Tumour Response Assessed by Response Evaluation Criteria in Solid Tumors (RECIST).
Timepoint [1] 0 0
up to 14 weeks
Secondary outcome [2] 0 0
Number of Patients With Tumor Metabolic Response as Assessed by Serial 18F-FDG-PET Scans.
Timepoint [2] 0 0
7 weeks
Secondary outcome [3] 0 0
Whole Body Clearance as Measured by Mean Biological Half-life (T1/2) After the First and Fifth Infusions of 124I-cG250.
Timepoint [3] 0 0
7 weeks
Secondary outcome [4] 0 0
Whole Body Clearance as Measured by Mean Effective Half-life (T1/2) After the First and Fifth Infusions of 124I-cG250.
Timepoint [4] 0 0
7 weeks
Secondary outcome [5] 0 0
Number of Patients With 124I-cG250 Tumor Uptake After the First and Fifth Infusions of 124I-cG250.
Timepoint [5] 0 0
7 weeks
Secondary outcome [6] 0 0
Serum Pharmacokinetics as Measured by Mean Initial Half-life (T½ a) and Mean Terminal Half-life (T½ ß) After the First and Fifth Infusions of 124I-cG250 as Measured by Blood 124I Radioactivity and After the First Dose as Measured by ELISA.
Timepoint [6] 0 0
7 weeks
Secondary outcome [7] 0 0
Serum Pharmacokinetics as Measured by Mean Volume of Central Compartment (V1) After the First and Fifth Infusions of 124I-cG250 as Measured by Blood 124I Radioactivity and After the First Dose as Measured by ELISA.
Timepoint [7] 0 0
7 weeks
Secondary outcome [8] 0 0
Serum Pharmacokinetics as Measured by Mean Area Under the Concentration Curve Extrapolated to Infinite Time (AUC) After the First and Fifth Infusions of 124I-cG250 as Measured by Blood 124I Radioactivity and After the First Dose as Measured by ELISA.
Timepoint [8] 0 0
7 weeks
Secondary outcome [9] 0 0
Serum Pharmacokinetics as Measured by Mean Total Serum Clearance (CL) After the First and Fifth Infusions of 124I-cG250 as Measured by Blood 124I Radioactivity and After the First Dose as Measured by ELISA.
Timepoint [9] 0 0
7 weeks
Secondary outcome [10] 0 0
Serum Pharmacokinetics as Measured by Mean Maximum Serum Concentration (Cmax) After the First and Fifth Infusions of 124I-cG250 as Measured by Blood 124I Radioactivity and After the First Dose as Measured by ELISA.
Timepoint [10] 0 0
7 weeks
Secondary outcome [11] 0 0
Number of Patients With Decreases in Tumour Blood Flow on Week 3 Versus Baseline.
Timepoint [11] 0 0
7 weeks
Secondary outcome [12] 0 0
Number of Patients With Human Anti-chimeric Antibodies (HACA)
Timepoint [12] 0 0
7 - 14 weeks

Eligibility
Key inclusion criteria
* Metastatic or unresectable Renal Cell Cancer (with clear cell component).
* Measurable disease by RECIST on CT with at least one measurable lesion 2 cm or greater in diameter, which is deemed to be assessable by PET imaging.
* At least 4 weeks after chemotherapy, radiotherapy or immunotherapy (6 weeks for nitrosourea drugs).
* Expected survival at least 3 months.
* Karnofsky performance status (KPS) of 70% or greater.
* Age 18 years or older.
* Vital laboratory parameters within normal, or protocol specified ranges.
* Left ventricular ejection fraction greater than 55% on GCBP scan.
* Systolic blood pressure =150mmHg and diastolic blood pressure =90mmHg.
* Able to give written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior exposure to cG250 monoclonal antibody (exception: no circulating human anti-chimeric antibody to cG250).
* Prior treatment with vascular endothelial growth factor (VEGF)-targeting agents (e.g. bevacizumab) or multi-kinase inhibitors (e.g. sorafenib) not including sunitinib. (Patients currently receiving sunitinib may be eligible if tolerating a stable dose of sunitinib on a four week on / two week off regimen, with toxicity due to sunitinib = CTCAE grade 2; and for whom the investigator deems it clinically reasonable to withhold sunitinib for at least four weeks prior to commencement of study treatment.)
* Active central nervous system (CNS) metastases (exception: CNS metastases adequately treated (surgery or radiotherapy) with no progression for at least three months).
* Known HIV positivity.
* Clinically significant heart disease.
* History of hypertension requiring hospitalisation.
* Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders.
* Major surgery or radiation therapy within 4 weeks prior to, or planned within 6 weeks of starting the study treatment. (Prior palliative radiotherapy to metastatic lesion(s) permitted, provided at least one measurable lesion was not irradiated or has progressed following radiotherapy.)
* Severe haemorrhage within 4 weeks prior to starting the study treatment.
* Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
* Pre-existing thyroid abnormality with unstable thyroid function despite medication.
* Ongoing moderate to severe cardiac dysrhythmias, any severity of atrial fibrillation, or prolongation of the corrected QT interval (QTc) to greater than 450 millisecond for males or 470 millisecond for females.
* Participation in a clinical trial involving another investigational agent within 4 weeks.
* Pregnancy or breastfeeding.
* Women of childbearing potential not using a medically acceptable means of contraception.
* Psychiatric or addictive disorders that may compromise the ability to give informed consent.
* Not available for follow-up assessment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2012
Sample size
Target
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health (Ludwig Institute Oncology Unit) - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg

Funding & Sponsors
Primary sponsor type
Other
Name
Ludwig Institute for Cancer Research
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Heidelberg Pharma AG
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
A/Prof Ian D Davis, FRACP, FAChPM, MBBS, PhD
Address 0 0
Ludwig Institute for Cancer Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00520533