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.

Launched by ASTRAZENECA · Oct 12, 2010

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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)