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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/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
Treatment: Drugs - LOP628

Experimental: LOP628 - Solid Tumor - with LOP628

Experimental: LOP628 - AML - With LOP628

Experimental: LOP628 - Solid Tumor Expansion - With LOP628


Treatment: Drugs: LOP628
Intervention code [1] 0 0
Treatment: Drugs
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
Terminated
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
LOP628 is an antibody-drug conjugate (ADC) consisting of an anti-cKit humanized IgG1/?
antibody conjugated to a maytansine payload via a non-cleavable linker.

LOP628 provides an opportunity to target cKit overexpressing tumors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02221505
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02221505