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
- Conditions
- Acute Myeloide LeukemiaGISTSmall Cell Lung cancer10027655
- Registration Number
- NL-OMON42287
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Main inclusion criteria (all patients)
*Documented cKit-positive neoplasms or AML
*ECOG Performance status of * 2;Inclusion criteria for patients with solid tumors
*Progressive disease as defined as either of the following:
o Patients with SCLC: have progressed after at least 1 prior therapy
o Patients with GIST: have relapsed or has refractory disease, and no further approved effective therapeutic option exists
o Patients with other cKit-positive solid tumors (dose escalation only): have progressed after at least one prior line of therapy and no further approved effective therapeutic option exists
*Measurable disease as per RECIST v1.1 criteria ;Inclusion criteria for patients with AML
*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.;For all inclusion criteria refer to protocol section 5.2.2 page 23-24
Main Exclusion criteria for all patients
*Presence of other clinically significant hematologic, cardiac, respiratory, gastrointestinal, renal, hepatic or neurological conditions.
*History of serious allergic reactions, which may pose an increased risk of serious infusion reactions.
*Previously treated with cKit directed therapies ;Exclusion criteria for patients with solid tumors
*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. ;Exclusion criteria for patients with AML
*Prior allogeneic bone marrow transplant (BMT).;For all exclusion criteria refer to protocol section 5.2.3 page 2-25
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Incidence rate of dose limiting toxicities (DLTs)</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Incidence and severity of AEs and SAEs; including changes in laboratory<br /><br>values; vital signs and ECGs<br /><br>- Serum PK parameters (eg, AUC, Cmax, Tmax, half-life); Serum concentration vs.<br /><br>time profiles<br /><br>- Presence and/or concentration of anti-LOP628 antibodies<br /><br>- GIST and SCLC: Overall response rate (ORR); Duration of response (DOR); PFS;<br /><br>Disease Control Rate (DCR) at 4 months; best overall response (BOR)<br /><br>- AML: percent of patients with CR, CRi, PR; BOR; duration of response (DOR);<br /><br>and PFS</p><br>