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.
This study has been terminated.
(Compound development discontinued)
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01219543
First received: October 11, 2010
Last updated: January 7, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumour Advanced Solid Malignancies Child-Pugh A to B7 Advanced Hepatocellular Carcinoma EGFR and/or ROS Mutant NSCLC Lung Metastasis Carcinoma Gastric Cancer |
Drug: AZD1480 Daily Drug: AZD1480 BID |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- To investigate the safety and tolerability of AZD1480 [ 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate the pharmacokinetics (PK) of AZD1480 following single dose and multiple doses [ Time Frame: Part A and Expansion - 12 times during Cycle 1, 11 times during Cycle 2. Part B and C - 11 times during Cycle 1, 10 times during Cycle 2. *1 additional PK sample in Cycle 1 will be collect for optional biopsy sample collected patients. ] [ Designated as safety issue: No ]
- To obtain a preliminary assessment of the anti-tumour activity of AZD1480 [ Time Frame: Tumour response assessment by RECIST (Response Evaluation Criteria In Solid Tumors) version 1.1 every 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 47 |
| Study Start Date: | November 2010 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Part A
Daily dosing of AZD1480 to the patients with solid tumours excluding HCC
|
Drug: AZD1480 Daily
Oral Dose, Capsule, Daily Dosing
|
|
Experimental: Part B
BID dosing of AZD1480 to the patients with advanced HCC (Child-Pugh A to B7)
|
Drug: AZD1480 BID
Oral Dose, Capsule, BID Dosing
|
|
Experimental: Part C
BID dosing of AZD1480 to the patients with solid tumours excluding HCC
|
Drug: AZD1480 BID
Oral Dose, Capsule, BID Dosing
|
|
Experimental: 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.
|
Drug: AZD1480 BID
Oral Dose, Capsule, BID Dosing
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01219543
Locations
| Korea, Republic of | |
| Research Site | |
| Seoul, Korea, Republic of | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Becker Hewes, MD | AstraZeneca |
| Principal Investigator: | Kang Yoon-Koo, MD, PhD | Asian Medical Center |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01219543 History of Changes |
| Other Study ID Numbers: | D1060C00004 |
| Study First Received: | October 11, 2010 |
| Last Updated: | January 7, 2013 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) South Korea: Institutional Review Board |
Keywords provided by AstraZeneca:
|
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 |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma Carcinoma, Non-Small-Cell Lung Stomach Neoplasms Neoplasm Metastasis Neoplasms, Second Primary Lung Neoplasms Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Lung Diseases Respiratory Tract Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Neoplastic Processes Pathologic Processes Adenocarcinoma Liver Neoplasms Liver Diseases |
ClinicalTrials.gov processed this record on May 16, 2013