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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01139138




Registration number
NCT01139138
Ethics application status
Date submitted
28/05/2010
Date registered
8/06/2010
Date last updated
6/11/2017

Titles & IDs
Public title
Safety Study of the Combination of Panitumumab, Irinotecan and Everolimus in the Treatment of Advanced Colorectal Cancer
Scientific title
A Phase IB/II Study of Second Line Therapy With Panitumumab, Irinotecan and Everolimus (PIE) in Metastatic Colorectal Cancer With KRAS WT
Secondary ID [1] 0 0
AU-2009-0003/CRAD001CAU06T
Universal Trial Number (UTN)
Trial acronym
PIE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Colorectal Carcinoma 0 0
Colorectal Tumors 0 0
Neoplasms, Colorectal 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Panitumumab
Treatment: Drugs - Irinotecan
Treatment: Drugs - Everolimus

Experimental: Panitumumab + Irinotecan + Everolimus -


Treatment: Drugs: Panitumumab
Panitumumab 6mg/kg IV every 14 days

Treatment: Drugs: Irinotecan
Irinotecan 200mg/m2 IV every 14 days

Treatment: Drugs: Everolimus
Everolimus daily po (dosage varies with cohort)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose limiting toxicities
Timepoint [1] 0 0
at end of cycle 2 (each cycle is 14 days)
Secondary outcome [1] 0 0
Safety & toxicity
Timepoint [1] 0 0
Approximately 24 weeks
Secondary outcome [2] 0 0
Response rate
Timepoint [2] 0 0
Assessed every 6 weeks until disease progression
Secondary outcome [3] 0 0
Progression free survival
Timepoint [3] 0 0
Until disease progression, occurrence of new disease or death
Secondary outcome [4] 0 0
Overall Survival
Timepoint [4] 0 0
Assessed 3 monthly until death

Eligibility
Key inclusion criteria
* Age > 18 years
* Histological diagnosis of colorectal cancer that is KRAS wild type
* Metastatic disease not amenable to resection
* Measurable disease as assessed by CT scan using RECIST criteria
* Received and failed fluoropyrimidine therapy
* Radiographically documented disease progression per RECIST criteria
* For phase 1b group only, ECOG PS 0-1
* For phase 2 group only, ECOG PS 0-2
* Adequate bone marrow function with haemoglobin > 100 g/L, platelets > 100 X 109/l; neutrophils > 1.5 X 109/l within 7 days of enrolment
* Adequate renal function, with calculated creatinine clearance >40 ml/min (Cockcroft and Gault) within 7 days of enrolment
* Adequate hepatic function with serum total bilirubin < 1.25 X upper limit of normal range and ALT or AST<2.5xULN (<5xULN if liver metastases present) within 7 days of enrolment
* Magnesium = lower limit of normal within 7 days of enrolment.
* Fasting serum cholesterol = 7.75mmol/L AND fasting triglycerides = 2.5 x ULN. Note: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
* Life expectancy of at least 12 weeks
* Negative pregnancy test = 72 hours before commencing study treatment (women of childbearing potential only).
* Written informed consent including consent for biomarker studies
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Presence of KRAS mutation in tumour sample
* For Phase 1b group only, patients with prior pelvic radiotherapy.
* Systemic chemotherapy, immunotherapy, approved proteins/antibodies or any investigational agent within 4 weeks prior to commencing study treatment
* Radiotherapy within 14 days of commencing study treatment.
* Unresolved toxicities from prior systemic therapy or radiotherapy
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent or to complete the protocol
* Prior treatment with drugs targeting EGFR such as cetuximab, panitumumab or erlotinib
* Prior therapy with mTOR inhibitors (sirolimus, temsirolimus, everolimus)
* Prior therapy with irinotecan
* CYP3A4 enzyme inducing anti-convulsant medication = 14 days prior to study treatment.
* Ketoconazole = 7 days before study treatment.
* Uncontrolled diabetes mellitus defined by fasting glucose >1.5 x ULN.
* Known cirrhosis, chronic active hepatitis, or chronic persistent hepatitis
* Patients with known interstitial lung disease or severely impaired lung function
* Patients with active bleeding diatheses.
* Any uncontrolled clinically significant cardiac disease, arrhythmias or angina pectoris
* Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea
* Chronic treatment with immunosuppressives
* Patients with a known history of HIV seropositivity
* Patients who have any severe and/or uncontrolled medical conditions or infections
* Untreated or symptomatic CNS metastases
* Patients who have a history of another primary malignant disease
* Pregnancy or lactation.
* Women and partners of women of childbearing potential who are not using effective contraception.

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2017
Sample size
Target
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5011 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
The Queen Elizabeth Hospital
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Amgen
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Novartis
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
Amanda Townsend, MBBS
Address 0 0
The Queen Elizabeth Hospital
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

No information has been provided regarding IPD availability


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 not provided in https://clinicaltrials.gov/study/NCT01139138