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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01139138
Other study ID # AU-2009-0003/CRAD001CAU06T
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received May 28, 2010
Last updated November 2, 2017
Start date June 2010
Est. completion date June 2017

Study information

Verified date November 2017
Source The Queen Elizabeth Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will assess the safety of panitumumab, irinotecan and everolimus when given in combination to treat advanced colorectal cancer


Description:

This is an open label uncontrolled phase IB/II study to determine the maximum tolerated dose (MTD) and assess the efficacy of everolimus, irinotecan and panitumumab when given in combination for patients with metastatic colorectal cancer and KRAS wild-type (WT). Patients with metastatic colorectal cancer (mCRC) that have failed fluorouracil based first line therapy will be included. It is anticipated that approximately 50 patients will be enrolled over a period of 24 months


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date June 2017
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

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


Intervention

Drug:
Panitumumab
Panitumumab 6mg/kg IV every 14 days
Irinotecan
Irinotecan 200mg/m2 IV every 14 days
Everolimus
Everolimus daily po (dosage varies with cohort)

Locations

Country Name City State
Australia The Queen Elizabeth Hospital Adelaide South Australia

Sponsors (3)

Lead Sponsor Collaborator
The Queen Elizabeth Hospital Amgen, Novartis

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose limiting toxicities To determine the maximum tolerated dose (MTD)of everolimus, irinotecan and panitumumab when given in combination for patients with Kras WT mCRC at end of cycle 2 (each cycle is 14 days)
Secondary Safety & toxicity Safety and toxicity assessed weekly during the phase Ib component (as per NCI CTCAE version 3.0) and fortnightly during the phase II component Approximately 24 weeks
Secondary Response rate Objective tumour response as per RECIST criteria V1.0 Assessed every 6 weeks until disease progression
Secondary Progression free survival Until disease progression, occurrence of new disease or death
Secondary Overall Survival Assessed 3 monthly until death
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