Study to Assess Safety, Tolerability and PK of AZD1480 in... | NCT01112397

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

NCT01112397

Sponsor

AstraZeneca

Status

Terminated

Last Update Posted

Jul 22, 2013Estimated

Enrollment

72Actual

Phase

Phase 1

Conditions

Solid Malignancies

Interventions

AZD1480

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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.

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Decision to stop development of AZD1480

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Apr 23, 2010

First Submission Date that Met QC Criteria

Apr 27, 2010

First Posted Date

Apr 28, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2013

Last Update Posted Date

Jul 22, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	AZD1480 until Maximum Tolerated Dose (MTD) is reached	Drug: AZD1480
2	Experimental	AZD1480 dose expansion of MTD	Drug: AZD1480

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD1480	Drug	continuous daily oral capsule	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)		Information will be collected from the time the informed consent is signed, throughout the study

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of the pharmacokinetics of AZD1480		During all cycles

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gregory Curt, MD	AstraZeneca	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Aurora	Colorado		United States
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C545606	AZD 1480

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided