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.

NCT ID: NCT01219543

Last Updated: 2013-01-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-12-31

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 with advanced HCC (Part B) in the escalation phase, EGFR or ROS mutant NSCLC and non-smokers with lung metastasis and gastric cancer in the expansion phase and to evaluate daily and BID dosing.

Conditions

Solid Tumour; Advanced Solid Malignancies; Child-Pugh A to B7 Advanced Hepatocellular Carcinoma; EGFR and/or ROS Mutant NSCLC; Lung Metastasis Carcinoma; Gastric Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A

Daily dosing of AZD1480 to the patients with solid tumours excluding HCC

Group Type: EXPERIMENTAL

AZD1480 Daily

Intervention Type: DRUG

Oral Dose, Capsule, Daily Dosing

Part B

BID dosing of AZD1480 to the patients with advanced HCC (Child-Pugh A to B7)

Group Type: EXPERIMENTAL

AZD1480 BID

Intervention Type: DRUG

Oral Dose, Capsule, BID Dosing

Part C

BID dosing of AZD1480 to the patients with solid tumours excluding HCC

Group Type: EXPERIMENTAL

AZD1480 BID

Intervention Type: DRUG

Oral Dose, Capsule, BID Dosing

Expansion

BID dosing of AZD1480 to the patients with EGFR or ROS mutant NSCLC and non-smokers with lung metastasis and gastric cancer and solid tumour with biopsy available.

Group Type: EXPERIMENTAL

AZD1480 BID

Intervention Type: DRUG

Oral Dose, Capsule, BID Dosing

Interventions

AZD1480 Daily

Oral Dose, Capsule, Daily Dosing

Intervention Type: DRUG

AZD1480 BID

Oral Dose, Capsule, BID Dosing

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Becker Hewes, MD

Role: STUDY_DIRECTOR

AstraZeneca

Kang Yoon-Koo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asian Medical Center

Locations

Research Site

Seoul, , South Korea

Countries

South Korea

Other Identifiers

D1060C00004

Identifier Type: -

Identifier Source: org_study_id