Study to Assess Safety, Tolerability and PK of AZD1480 in Patients With Solid Tumours

This study has been terminated.
(Decision to stop development of AZD1480)
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01112397
First received: April 23, 2010
Last updated: July 19, 2013
Last verified: July 2013
  Purpose

This study is being conducted to assess the safety, tolerability and PK of AZD1480 in patients with advanced solid malignancies.


Condition Intervention Phase
Solid Malignancies
Drug: AZD1480
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, Multi-Center, Dose-Escalation Study to Assess the Safety and Tolerability, and Pharmacokinetics of AZD1480 Administered as Daily Oral Monotherapy in Patients With Advanced Solid Malignancies in the Escalation Phase and EGFR or ROS Mutant NSCLC or Non-Smokers With Lung Metastasis in the Expansion Phase.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety and tolerability as assessed by Adverse events, vital signs, ECGs, Pulmonary Function Tests (DLco, FEV, FVC, Oxygen saturation) and laboratory data (chemistry, hematology and Urinalysis) [ Time Frame: Information will be collected from the time the informed consent is signed, throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of the pharmacokinetics of AZD1480 [ Time Frame: During all cycles ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: April 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD1480 until Maximum Tolerated Dose (MTD) is reached
Drug: AZD1480
continuous daily oral capsule
Experimental: 2
AZD1480 dose expansion of MTD
Drug: AZD1480
continuous daily oral capsule

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with advanced solid cancer without available therapy in the escalation phase and mutation positive NSCLC or non-smokers with other primary tumors lung metastasis in the expansion phase
  • ECOG Performance Status 0-1
  • Evidence of post-menopausal status in females or males willing to use barrier contraception

Exclusion Criteria:

  • Prior therapy with any JAK2 medications
  • Significant lung disorder or lung disease. Previous radiation therapy to chest wall or chest infection requiring antibiotic treatment within 21 days before study screening. Evidence of significant pulmonary hypertension or COPD
  • Eye disease of the cornea
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112397

Locations
United States, Colorado
Research Site
Aurora, Colorado, United States
United States, Michigan
Research Site
Detroit, Michigan, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Gregory Curt, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01112397     History of Changes
Other Study ID Numbers: D1060C00002
Study First Received: April 23, 2010
Last Updated: July 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Jak2
cancer
jak 1
stat 3
Phase 1

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014