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Phase 1 Study of LOP628 in Adult Patients With cKit-positive Solid Tumors and Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT02221505
Recruitment Status : Terminated
First Posted : August 20, 2014
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.


Condition or disease Intervention/treatment Phase
cKIT-positive Solid Tumors AML Drug: LOP628 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : December 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015


Arm Intervention/treatment
Experimental: LOP628 - Solid Tumor
with LOP628
Drug: LOP628
Experimental: LOP628 - AML
With LOP628
Drug: LOP628
Experimental: LOP628 - Solid Tumor Expansion
With LOP628
Drug: LOP628



Primary Outcome Measures :
  1. Incident rate of dose limiting toxicities (DLTs) [ Time Frame: Month 12 ]
    To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE)


Secondary Outcome Measures :
  1. Incidence of adverse events (AEs) and serious adverse events (SAE) [ Time Frame: 30 months ]
    Characterize the safety and tolerability of LOP628

  2. Severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 30 months ]
    Characterize the safety and tolerability of LOP628

  3. Serum PK parameters (AUC, Cmax, Tmax, and half-life) [ Time Frame: 30 months ]
    To characterize the pharmacokinetic profile of LOP628

  4. Serum concentration vs. time profiles [ Time Frame: 30 months ]
    To characterize the pharmacokinetic profile of LOP628.

  5. Overall response rate (ORR) [ Time Frame: 30 months ]
    To assess the preliminary anti-tumor activity of LOP628

  6. Duration of response (DOR) [ Time Frame: 30 months ]
    To assess the preliminary anti-tumor activity of LOP628

  7. Progression Free Survival (PFS) [ Time Frame: 30 months ]
    To assess the preliminary anti-tumor activity of LOP628

  8. Disease Control Rate (DCR) at 4 months [ Time Frame: 4 months ]
    To assess the preliminary anti-tumor activity of LOP628

  9. Best overall response (BOR) [ Time Frame: 30 months ]
    To assess the preliminary anti-tumor activity of LOP628 in patients

  10. Best Overall Response (AML) [ Time Frame: 30 months ]
    To assess the preliminary anti-tumor activity of LOP628

  11. Duration of response (DOR) (AML) [ Time Frame: 30 months ]
    To assess the preliminary anti-tumor activity of LOP628

  12. Event Free Survival (EFS) (AML) [ Time Frame: 30 months ]
    To assess the preliminary anti-tumor activity of LOP628



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221505


Locations
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Australia, Victoria
Novartis Investigative Site
Parkville, Victoria, Australia, 3050
Belgium
Novartis Investigative Site
Leuven, Belgium, 3000
Netherlands
Novartis Investigative Site
Leiden, Netherlands, 2300 RC
Spain
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02221505     History of Changes
Other Study ID Numbers: CLOP628X2101
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: April 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
LOP628,
cKit,
ADC,
Antibody drug conjugates,
maytansine
Additional relevant MeSH terms:
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Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid