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

Sponsor
Dizal Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT03450330
Collaborator
(none)
10
Enrollment
4
Locations
1
Arm
20.8
Actual Duration (Months)
2.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
dose escalationdose escalation
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Apr 16, 2018
Actual Primary Completion Date :
Sep 3, 2019
Actual Study Completion Date :
Jan 10, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: daily dose of AZD4205

daily dose of AZD4205

Drug: AZD4205
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.

Outcome Measures

Primary Outcome Measures

  1. safety and tolerability of AZD4205 [21 days after the first dose]

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

Secondary Outcome Measures

  1. Objective Response Rate (ORR) [RECIST tumour assessments every 6 weeks from enrollment until study completion, an average of 1 year]

    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.

  2. Peak Plasma Concentration (Cmax) of AZD4205 [1,8,15 days after first dose]

    Peak Plasma Concentration (Cmax) of AZD4205

  3. Area under the plasma concentration versus time curve (AUC) of AZD4205 [1,8,15 days after first dose]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Obtained written informed consent

  2. Patients must have histological or cytological confirmation of activating EGFR mutation positive NSCLC and have failed prior EGFR TKIs treatment.

  3. Patients must exhibit Eastern Cooperative Oncology Group (ECOG) performance status 0-1

  4. Adequate bone marrow reserve and organ system functions

Exclusion Criteria:

  1. Any unsolved toxicity > CTCAE grade 1 from previous anti-cancer therapy (except alopecia)

  2. Active viral or bacterial infections;

  3. Active or latent tuberculosis;

  4. History of interstitial lung disease (ILD)

  5. History of heart failure or QT interval prolongation

  6. Immunodeficiency diseases;

  7. Active CNS metastases

  8. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 St George Hospital Sydney New South Wales Australia
2 Austin Hospital Heidelberg Victoria Australia 3084
3 Peter MacCallum Cancer Centre Melbourne Victoria Australia
4 Northern Cancer Institute St Leonards Sydney Australia 2066

Sponsors and Collaborators

  • Dizal Pharmaceuticals

Investigators

  • Study Director: Pamela Yang, MD, PhD, Dizal (Jiangsu) Pharmaceutical Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dizal Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT03450330
Other Study ID Numbers:
  • DZ2017J0001
First Posted:
Mar 1, 2018
Last Update Posted:
Aug 24, 2020
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Aug 24, 2020