Status:
TERMINATED
A Phase I Study of AZD1480 in Patients With Advanced Solid Malignancies and Advanced Hepatocellular Carcinoma in the Escalation Phase,Non-Small Cell Lung Cancer(NSCLC) and Non-smokers With Lung Metastasis and Gastric Cancer and Solid Tumour in the Expansion Phase.
Lead Sponsor:
AstraZeneca
Conditions:
Solid Tumour
Advanced Solid Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is Phase I, open-label and dose escalation study to evaluate the safety and tolerability of AZD1480(JAK2 inhibitor) in Asian patients with advanced solid tumors (Part A and C) and in patients wit...
Eligibility Criteria
Inclusion
- Male or female aged 18 years or older
- For Part A and C: Histological or cytological confirmation of a solid malignant tumour refractory to standard therapies or for which no standard therapies exist. Patients with lymphoma \& HCC are excluded.
- For Expansion : Histological or cytological confirmation of
- Expansion 1: EGFR and/or ROS mutant NSCLC or Non-smokers with lung metastasis
- Expansion 2: Gastric cancer or solid tumour with biopsy available (consenting paired biopsies)refractory to standard therapies or for which no standard therapies exist. Patients with lymphoma \& HCC are excluded.
- For Part B : Advanced or metastatic HCC, unresectable and incurable with ablative therapy or TACE, with no standard therapy available.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 with no deterioration over the previous 2 weeks
- For Part B : Child-Pugh liver function status classified as A to B7
Exclusion
- For any other chemotherapy, immunotherapy or anticancer agents, within 5 half lives or 3 weeks must have elapsed from treatment to of the first dose of investigational product, whichever is shorter.
- With the exception of alopecia, any unresolved toxicities from prior therapy ≥ Grade 2 of CTCAE V4.02 at the time of starting study (except LFTs for HCC patients, which may be Grade 2 at the time of starting the study)
- Any of the following conditions:Interferon treatment for HBV and HCV Prior Liver Transplantation
- Inadequate bone marrow reserve or organ function as demonstrated by laboratory values
- Evidence of established interstitial lung disease(ILD) on baseline high resolution computerized tomography(HRCT)
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01219543
Start Date
November 1 2010
End Date
December 1 2012
Last Update
January 8 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Seoul, South Korea