Advanced solid tumors and Colorectal Cancer
Conditions
Interventions
ARM 1 escalation: LBY135 alone (advanced solid tumors)
ARM 1B expansion: LBY135 alone (advanced solid tumors)
ARM 2 escalation: LBY135 in combination with Xeloda (advanced solid tumors)
Sponsors
Novartis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Arm 1:Patients with an advanced solid tumor who have progressed despite standard therapy or for which standard treatment options do not exist • Arm 2: Patients with an advanced solid tumor who have progressed or for which standard treatment options do not exist, and who are considered appropriate for capecitabine treatment • Patients must have adequate bone marrow function, no severe liver and kidney functions disorder. Additional inclusion criteria for CRC dose expansion cohorts (Arm 1B/2A): • Arm 1B (single agent LBY135): Patients with histologically-confirmed diagnosis of CRC (advanced unresectable or metastatic disease - stages IV and IIIb AJCC criteria) and for whom standard treatment options do not exist • Arm 2 (LBY135 plus capecitabine): Patients with histologically-confirmed diagnosis of CRC (advanced unresectable or metastatic disease stages IV and IIIb AJCC criteria), who are relapsed after or refractory to at least one but not more than two prior systemic therapies (i.e. chemotherapies, targeted therapies or immunotherapies) for unresectable or metastatic disease.
Exclusion criteria
Exclusion criteria: • A history or presence of primary central nervous system tumors or brain metastases • Acute or chronic liver disease or renal disease • Patients with any peripheral neuropathy >= CTCAE grade 2 • Patients with unresolved diarrhea >= CTCAE grade 2 • Any of the following concurrent severe and/or uncontrolled medical conditions: Impaired cardiac function or clinically significant cardiac diseases; symptomatic congestive heart failure; labile hypertension; uncontrolled diabetes, active or uncontrolled infection • Patients with known autoimmune disease • Patients with known anti-murine antibody responses • Patients who have been treated with any hematopoietic colony-stimulating growth factors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the maximum-tolerated dose (MTD) and doselimiting toxicity (DLT) of single agent LBY135 and LBY135 when administered in combination with capecitabine, by increasing the dose in cohorts of minimum of 3 patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics and pharmacodynamics of LBY135 (blood samples) | — |
Countries
Netherlands
Outcome results
None listed