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A Phase I, Open-label, Multicentre, Dose Escalation Study to Assess the Safety and Tolerability, and Pharmacokinetics of AZD1480 in Asian Patients With Advanced Solid Malignancies and Asian Patients With Child-Pugh A to B7 Advanced Hepatocellular Carcinoma (HCC) in the Escalation Phase, Estimated Glomerular Filtration Rate(EGFR) or ROS Mutant NSCLC and Non-smokers With Lung Metastasis and Gastric Cancer and Solid Tumour With Biopsy Available in the Expansion Phase.


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumour, Advanced Solid Malignancies, Child-Pugh A to B7 Advanced Hepatocellular Carcinoma, EGFR and/or ROS Mutant NSCLC, Lung Metastasis Carcinoma, Gastric Cancer

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Trial Information

A Phase I, Open-label, Multicentre, Dose Escalation Study to Assess the Safety and Tolerability, and Pharmacokinetics of AZD1480 in Asian Patients With Advanced Solid Malignancies and Asian Patients With Child-Pugh A to B7 Advanced Hepatocellular Carcinoma (HCC) in the Escalation Phase, Estimated Glomerular Filtration Rate(EGFR) or ROS Mutant NSCLC and Non-smokers With Lung Metastasis and Gastric Cancer and Solid Tumour With Biopsy Available in the Expansion Phase.


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To investigate the safety and tolerability of AZD1480

Outcome Time Frame:

Safety and tolerability monitoring will proceed for whole study period. Screening, Cycle1Day1, Cycle1Day5 (only for Part B), Cycle1Day8, Cycle1Day15, Cycle2Day1, Cycle2Day8 and Day1 of further Cycles, IP discontinued visit and 30-days follow up

Safety Issue:

Yes

Principal Investigator

Becker Hewes, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

D1060C00004

NCT ID:

NCT01219543

Start Date:

November 2010

Completion Date:

December 2012

Related Keywords:

  • Solid Tumour
  • Advanced Solid Malignancies
  • Child-Pugh A to B7 Advanced Hepatocellular Carcinoma
  • EGFR and/or ROS Mutant NSCLC
  • Lung Metastasis Carcinoma
  • Gastric Cancer
  • Advanced solid malignancies
  • Child-Pugh A to B7 advanced hepatocellular carcinoma
  • EGFR and/or ROS mutant NSCLC
  • Non-smokers with lung metastasis
  • Gastric cancer
  • Solid tumour
  • AZD1480
  • JAK1/JAK2 kinase inhibitor
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Stomach Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Lung Neoplasms
  • Carcinoma, Hepatocellular

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