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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02221505
Other study ID # CLOP628X2101
Secondary ID
Status Terminated
Phase Phase 1
First received August 8, 2014
Last updated April 2, 2016
Start date December 2014
Est. completion date March 2015

Study information

Verified date April 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial Summary

LOP628 is an antibody-drug conjugate (ADC) consisting of an anti-cKit humanized IgG1/κ antibody conjugated to a maytansine payload via a non-cleavable linker.

LOP628 provides an opportunity to target cKit overexpressing tumors.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
LOP628


Locations

Country Name City State
Australia Novartis Investigative Site Parkville Victoria
Belgium Novartis Investigative Site Leuven
Netherlands Novartis Investigative Site Leiden
Spain Novartis Investigative Site Barcelona Catalunya

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Belgium,  Netherlands,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incident rate of dose limiting toxicities (DLTs) To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE) Month 12 Yes
Secondary Incidence of adverse events (AEs) and serious adverse events (SAE) Characterize the safety and tolerability of LOP628 30 months Yes
Secondary Severity of adverse events (AEs) and serious adverse events (SAEs) Characterize the safety and tolerability of LOP628 30 months Yes
Secondary Serum PK parameters (AUC, Cmax, Tmax, and half-life) To characterize the pharmacokinetic profile of LOP628 30 months No
Secondary Serum concentration vs. time profiles To characterize the pharmacokinetic profile of LOP628. 30 months No
Secondary Overall response rate (ORR) To assess the preliminary anti-tumor activity of LOP628 30 months No
Secondary Duration of response (DOR) To assess the preliminary anti-tumor activity of LOP628 30 months No
Secondary Progression Free Survival (PFS) To assess the preliminary anti-tumor activity of LOP628 30 months No
Secondary Disease Control Rate (DCR) at 4 months To assess the preliminary anti-tumor activity of LOP628 4 months No
Secondary Best overall response (BOR) To assess the preliminary anti-tumor activity of LOP628 in patients 30 months No
Secondary Best Overall Response (AML) To assess the preliminary anti-tumor activity of LOP628 30 months No
Secondary Duration of response (DOR) (AML) To assess the preliminary anti-tumor activity of LOP628 30 months No
Secondary Event Free Survival (EFS) (AML) To assess the preliminary anti-tumor activity of LOP628 30 months No
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