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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02926768




Registration number
NCT02926768
Ethics application status
Date submitted
29/09/2016
Date registered
6/10/2016
Date last updated
26/07/2022

Titles & IDs
Public title
Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors
Scientific title
A Phase I/II, Open-Label, Safety, Pharmacokinetic and Efficacy Study of Ascending Doses of Oral CK-101 in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
CK-101-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Neoplasms 0 0
Carcinoma, Non-Small-Cell Lung 0 0
Lung Diseases 0 0
Adenocarcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CK-101

Experimental: Daily dose of CK-101 - Daily oral dose of CK-101


Treatment: Drugs: CK-101
Phase 1: CK-101 will be administered in escalating dosages in a period of 21-day cycles
Phase 2: CK-101 will be administered daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase I: Incidence of dose-limiting toxicities (DLTs)
Timepoint [1] 0 0
From baseline (first dose) to 28 days after last dose, expected average 6 months
Primary outcome [2] 0 0
Phase II: Objective response rate (ORR): Defined as the rate of complete responses [CR] or partial responses [PR] per RECIST Version 1.1 as assessed by an independent central review
Timepoint [2] 0 0
From baseline (first dose) until disease progression or withdrawal from study, expected average 10 months
Secondary outcome [1] 0 0
Phase II: Evaluation of tumor response based on disease control rate as assessed by RECIST 1.1
Timepoint [1] 0 0
From baseline (first dose) until disease progression or withdrawal from study, expected average 10 months
Secondary outcome [2] 0 0
Phase II: Evaluation of tumor response based on duration of response as assessed by RECIST 1.1
Timepoint [2] 0 0
From baseline (first dose) until disease progression or withdrawal from study, expected average 10 months
Secondary outcome [3] 0 0
Phase II: Evaluation of tumor response based on tumor shrinkage as assessed by RECIST 1.1
Timepoint [3] 0 0
From baseline (first dose) until disease progression or withdrawal from study, expected average 10 months
Secondary outcome [4] 0 0
Phase II: Evaluation of tumor response based on progression free survival as assessed by RECIST 1.1
Timepoint [4] 0 0
From baseline (first dose) until disease progression or withdrawal from study, expected average 10 months
Secondary outcome [5] 0 0
Phase I: Change from baseline in QT/QTc interval
Timepoint [5] 0 0
Cycle 1 Day 1 until disease progression or withdrawal from study, expected average 10 months
Secondary outcome [6] 0 0
Phase I: Plasma concentrations of CK-101 following dosing with CK-101 as assessed by area under the curve
Timepoint [6] 0 0
Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycle 2
Secondary outcome [7] 0 0
Phase I: Plasma concentrations of CK-101 following dosing with CK-101 as assessed by maximum concentration
Timepoint [7] 0 0
Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycle 2
Secondary outcome [8] 0 0
Phase I: Plasma concentrations of CK-101 following dosing with CK-101 as assessed by elimination half-life
Timepoint [8] 0 0
Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycle 2

Eligibility
Key inclusion criteria
- Measureable disease according to RECIST Version 1.1

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Minimum age of 18 years

- Adequate hematological, hepatic and renal function

- Written consent on an Institutional Review Board-approved informed consent form prior
to any study-specific evaluation

- Histologically or cytologically confirmed diagnosis of one of the following:

1. Metastatic or unresectable locally advanced NSCLC with documented evidence that
the tumor harbors one of the two common EGFR mutations known to be associated
with EGFR tyrosine kinase inhibitor (TKI) sensitivity (exon 19 deletion, L858R),
either alone or in combination with other EGFR mutations, determined by PCR-based
testing of the tumor tissue or plasma sample, and without prior exposure to an
EGFR-TKI therapy; OR

2. Metastatic or unresectable locally advanced NSCLC:

1. with documented evidence that the tumor harbors an EGFR mutation known to be
associated with EGFR TKI sensitivity (including G719X, exon 19 deletion,
L858R, L861Q); and

2. with evidence of radiological disease progression while on a previous
continuous treatment with a first-generation EGFR TKI. In addition, other
lines of therapy may have been given. All patients must have evidence of
radiological disease progression on or following the last treatment
administered; and

3. with documented evidence of EGFR T790M mutation determined by PCR-based
testing of the tumor tissue or plasma sample following disease progression
on most recent treatment regimen (irrespective of whether this is EGFR TKI
or chemotherapy).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Active second malignancy or other prior malignancy treated with chemotherapy less than
or equal to 6 months prior to treatment with CK-101

- History of, or evidence of clinically active, interstitial lung disease

- Brain metastases unless asymptomatic, stable and not requiring steroids for at least 2
weeks

- Treatment with prohibited medications

- Any toxicity related to prior treatment must have resolved to Grade 1 or less, with
the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy

- Certain cardiac abnormalities or history

- Non-study related surgical procedures less than or equal to 14 days prior to CK-101
administration

- Females who are pregnant or breastfeeding.

- Refusal to use adequate contraception for fertile patients (females and males)

- Presence of any serious or unstable concomitant systemic disorder incompatible with
the clinical study

- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to
swallow the formulated product or previous significant bowel resection

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2022
Sample size
Target
Accrual to date
Final
136
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Research Site - Greenslopes
Recruitment postcode(s) [1] 0 0
4120 - Greenslopes
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
New Zealand
State/province [5] 0 0
Auckland
Country [6] 0 0
New Zealand
State/province [6] 0 0
Christchurch
Country [7] 0 0
New Zealand
State/province [7] 0 0
Wellington
Country [8] 0 0
Poland
State/province [8] 0 0
Kujawsko-Pomorskie
Country [9] 0 0
Poland
State/province [9] 0 0
Lubelskie
Country [10] 0 0
Poland
State/province [10] 0 0
Podlaskie
Country [11] 0 0
Poland
State/province [11] 0 0
Wielkopolskie
Country [12] 0 0
Poland
State/province [12] 0 0
Zachodniopomorskie
Country [13] 0 0
Thailand
State/province [13] 0 0
Bangkok
Country [14] 0 0
Thailand
State/province [14] 0 0
Chiang Mai
Country [15] 0 0
Thailand
State/province [15] 0 0
Khon Kaen
Country [16] 0 0
Thailand
State/province [16] 0 0
Phitsanulok

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Checkpoint Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
CK-101 is a novel, potent, small molecule tyrosine kinase inhibitor (TKI) that selectively
targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type
(WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety
profile of oral CK-101; to determine the maximum tolerated dose (MTD) and/or recommended
Phase 2 dose (RP2D) of oral CK-101; to assess the safety and efficacy of CK-101 in
treatment-naive NSCLC patients known to have activating EGFR mutations and previously treated
NSCLC patients known to have the T790M EGFR mutation.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02926768
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries