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Assessing an Oral Janus Kinase Inhibitor, AZD4205, in Combination With Osimertinib in Patients Who Have Advanced Non-small Cell Lung Cancer (JACKPOT1)

Primary Purpose

Nonsmall Cell Lung Cancer

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

AZD4205

About this trial

This is an interventional treatment trial for Nonsmall Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Obtained written informed consent
Patients must have histological or cytological confirmation of activating EGFR mutation positive NSCLC and have failed prior EGFR TKIs treatment.
Patients must exhibit Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Adequate bone marrow reserve and organ system functions

Exclusion Criteria:

Any unsolved toxicity > CTCAE grade 1 from previous anti-cancer therapy (except alopecia)
Active viral or bacterial infections;
Active or latent tuberculosis;
History of interstitial lung disease (ILD)
History of heart failure or QT interval prolongation
Immunodeficiency diseases;
Active CNS metastases
Treatment with an EGFR TKI (e.g., erlotinib or gefitinib) within 8 days or approximately 5 x half-life, whichever is longer, of the first dose of study treatment

Sites / Locations

St George Hospital
Austin Hospital
Peter MacCallum Cancer Centre
Northern Cancer Institute St Leonards

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

daily dose of AZD4205

Arm Description

daily dose of AZD4205

Outcomes

Primary Outcome Measures

safety and tolerability of AZD4205

Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v4.0

Secondary Outcome Measures

Objective Response Rate (ORR)

Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (by investigator assessment) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.

Peak Plasma Concentration (Cmax) of AZD4205

Area under the plasma concentration versus time curve (AUC) of AZD4205

Full Information

NCT ID

NCT03450330

First Posted

January 25, 2018

Last Updated

August 20, 2020

Sponsor

Dizal Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03450330

Brief Title

Assessing an Oral Janus Kinase Inhibitor, AZD4205, in Combination With Osimertinib in Patients Who Have Advanced Non-small Cell Lung Cancer

Acronym

JACKPOT1

Official Title

A Phase I/II, Open-Label, Multicentre Study to Investigate the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of AZD4205 as Monotherapy or in Combination With Osimertinib in Patients With EGFR Mutant Advanced Stage Non-Small Cell Lung Cancer (NSCLC)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

April 16, 2018 (Actual)

Primary Completion Date

September 3, 2019 (Actual)

Study Completion Date

January 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dizal Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study will treat patients with advanced NSCLC who have progressed following prior therapy. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy and in combination with Osimertinib.

Detailed Description

A phase I/II, open-label, multicentre study to investigate the safety, tolerability, pharmacokinetics and anti-tumour activity of AZD4205 as monotherapy or in combination with Osimertinib in patients with EGFR mutant advanced stage non-small cell lung cancer (NSCLC). This study includes dose escalation part and dose expansion part.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nonsmall Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Model Description

dose escalation

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

daily dose of AZD4205

Arm Type

Experimental

Arm Description

daily dose of AZD4205

Intervention Type

Drug

Intervention Name(s)

AZD4205

Intervention Description

Daily dose of AZD4205, followed by daily dose of AZD4205 and Osimertinib 80 mg. Starting dose of AZD4205 at 75 mg, administered once daily. If tolerated, subsequent cohorts will test increasing doses of AZD4205, and in combination with Osimertinib 80 mg.

Primary Outcome Measure Information:

Title

safety and tolerability of AZD4205

Description

Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v4.0

Time Frame

21 days after the first dose

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

Time Frame

RECIST tumour assessments every 6 weeks from enrollment until study completion, an average of 1 year

Title

Peak Plasma Concentration (Cmax) of AZD4205

Description

Peak Plasma Concentration (Cmax) of AZD4205

Time Frame

1,8,15 days after first dose

Title

Area under the plasma concentration versus time curve (AUC) of AZD4205

Description

Area under the plasma concentration versus time curve (AUC) of AZD4205

Time Frame

1,8,15 days after first dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Obtained written informed consent Patients must have histological or cytological confirmation of activating EGFR mutation positive NSCLC and have failed prior EGFR TKIs treatment. Patients must exhibit Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Adequate bone marrow reserve and organ system functions Exclusion Criteria: Any unsolved toxicity > CTCAE grade 1 from previous anti-cancer therapy (except alopecia) Active viral or bacterial infections; Active or latent tuberculosis; History of interstitial lung disease (ILD) History of heart failure or QT interval prolongation Immunodeficiency diseases; Active CNS metastases Treatment with an EGFR TKI (e.g., erlotinib or gefitinib) within 8 days or approximately 5 x half-life, whichever is longer, of the first dose of study treatment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pamela Yang, MD, PhD

Organizational Affiliation

Dizal (Jiangsu) Pharmaceutical Co., Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

St George Hospital

City

Sydney

State/Province

New South Wales

Country

Australia

Facility Name

Austin Hospital

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

Peter MacCallum Cancer Centre

City

Melbourne

State/Province

Victoria

Country

Australia

Facility Name

Northern Cancer Institute St Leonards

City

Sydney

ZIP/Postal Code

2066

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Assessing an Oral Janus Kinase Inhibitor, AZD4205, in Combination With Osimertinib in Patients Who Have Advanced Non-small Cell Lung Cancer

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