Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02221505




Registration number
NCT02221505
Ethics application status
Date submitted
8/08/2014
Date registered
20/08/2014
Date last updated
5/04/2016

Titles & IDs
Public title
Phase 1 Study of LOP628 in Adult Patients With cKit-positive Solid Tumors and Acute Myeloid Leukemia
Scientific title
A Phase I, Multicenter, Open-label Dose Escalation and Expansion Study of LOP628, Administered Intravenously in Adult Patients With cKit-positive Tumors and Acute Myeloid Leukemia
Secondary ID [1] 0 0
CLOP628X2101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cKIT-positive Solid Tumors 0 0
AML 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: LOP628 - Solid Tumor - with LOP628

Experimental: LOP628 - AML - With LOP628

Experimental: LOP628 - Solid Tumor Expansion - With LOP628
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incident rate of dose limiting toxicities (DLTs)
Timepoint [1] 0 0
Month 12
Secondary outcome [1] 0 0
Incidence of adverse events (AEs) and serious adverse events (SAE)
Timepoint [1] 0 0
30 months
Secondary outcome [2] 0 0
Severity of adverse events (AEs) and serious adverse events (SAEs)
Timepoint [2] 0 0
30 months
Secondary outcome [3] 0 0
Serum PK parameters (AUC, Cmax, Tmax, and half-life)
Timepoint [3] 0 0
30 months
Secondary outcome [4] 0 0
Serum concentration vs. time profiles
Timepoint [4] 0 0
30 months
Secondary outcome [5] 0 0
Overall response rate (ORR)
Timepoint [5] 0 0
30 months
Secondary outcome [6] 0 0
Duration of response (DOR)
Timepoint [6] 0 0
30 months
Secondary outcome [7] 0 0
Progression Free Survival (PFS)
Timepoint [7] 0 0
30 months
Secondary outcome [8] 0 0
Disease Control Rate (DCR) at 4 months
Timepoint [8] 0 0
4 months
Secondary outcome [9] 0 0
Best overall response (BOR)
Timepoint [9] 0 0
30 months
Secondary outcome [10] 0 0
Best Overall Response (AML)
Timepoint [10] 0 0
30 months
Secondary outcome [11] 0 0
Duration of response (DOR) (AML)
Timepoint [11] 0 0
30 months
Secondary outcome [12] 0 0
Event Free Survival (EFS) (AML)
Timepoint [12] 0 0
30 months

Eligibility
Key inclusion criteria
For patients with solid tumors:

* documented cKit-positive neoplasms
* Patient must have progressive disease as defined by any of the following:
* SCLC: patient has progressed after at least 1 prior therapy
* GIST : patient has relapsed or has refractory disease, and no further approved effective therapeutic option exists
* Patients with other cKit-positive solid tumors: patient has progressed after at least one prior line of therapy and no further approved effective therapeutic option exists
* Patient has measurable disease as per RECIST v1.1 criteria

For patients with AML:

* documented cKit-positive acute myelogenous leukemia
* Consent to newly obtained bone marrow aspirate
* Patient must have progressive disease defined as relapsed or refractory non-PML AML following standard therapy or for whom no effective therapy exists.
* Blast count < 50,000/mm3
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For patients with solid tumors:

* Patient has central nervous system (CNS) metastatic involvement unless the CNS metastases have been previously treated and the patient is clinically stable and on a stable dose of corticosteroids for at least 4 weeks prior to enrollment.
* Patient has the presence of other clinically significant hematologic, cardiac, respiratory, gastrointestinal, renal, hepatic or neurological conditions.
* Patient has a history of serious allergic reactions, which in the opinion of the investigator may pose an increased risk of serious infusion reactions
* Patient has been previously treated with cKit directed antibodies
* Pregnant or nursing women

For patients with AML:

* Patient has received prior allogeneic bone marrow transplant (BMT).
* Patient has the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease
* Patient has a history of serious allergic reactions, which in the opinion of the investigator may pose an increased risk of serious infusion reactions
* Patient has been previously treated with cKit directed antibodies
* Pregnant or nursing women

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2015
Sample size
Target
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
Netherlands
State/province [2] 0 0
Leiden
Country [3] 0 0
Spain
State/province [3] 0 0
Catalunya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02221505