Trial Information

Summary: A phase 1 study of LP-261-01 in patients with advanced solid malignancies.

The primary objective of the study is to determine the maximally tolerated dose of LP-261 in patients with advanced solid malignancies. Patients may continue on therapy until there is evidence of progressive disease, intolerable toxicity, or fulfillment of any protocol criteria for withdrawal from the study.

Inclusion

• Patients must have histological evidence of a solid tumor
• Patients must have advanced solid tumors that have failed to respond to currently available standard therapy; that have recurred or progressed following currently available standard therapy; for which there is no currently available standard therapy; or who are not candidates for currently available standard therapy.
• Patients must be = 18 years of age
• Patients or their legal representative must be able to read, understand and sign an informed consent
• ECOG Performance Score of 0 or 1 (Appendix 1)
• Adequate bone marrow as evidenced by:
  • Absolute neutrophil count = 1,500/µL
  • Platelet count = 100,000/µL
• Adequate renal function as evidenced by serum creatinine = 2.0 mg/dL
• Adequate hepatic function as evidenced by:
  • Serum total bilirubin = 2.0 mg/dL
  • SGOT/SGPT = 3X the ULN for the reference lab = 5X the ULN for patients with known hepatic metastases)
• Patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy
• Women of childbearing potential as well as fertile men and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method). Women who are NOT of childbearing potential are those who have undergone a bilateral oophorectomy or who have undergone menopause, defined as an absence of a menstrual cycle for 12 consecutive months

Exclusion

• Patients with an active infection or with a fever = 38.50 C within 3 days of the first scheduled day of dosing
• Patients with symptomatic CNS metastases; patients with CNS metastases who have undergone surgery and/or radiotherapy, who have no neurological symptoms and who have been on a stable dose of corticosteroids for at least 2 weeks will be eligible for the trial.
• Prior treatment with more than 3 chemotherapy regimens; there is no limit on the number of prior hormonal, immunotherapeutic or other non-cytotoxic treatments
• Patients with known hypersensitivity to any of the components of LP-261
• Patients who are receiving concurrent investigational therapy or who have received investigational therapy within a period of 5 half-lives of the investigational therapy in question prior to the first scheduled day of dosing of LP-261 (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
• Grade 2 peripheral neuropathy
• QTc of > 450 msec
• Patients with NYHA Grade 3 or 4 congestive heart failure
• Patients who have unstable angina or who have experienced an acute myocardial infarction or an episode of acute coronary syndrome within 6 months of the initial dose of LP-261
• Patients on medications known to increase the QTc interval (See Appendix 8)
• Patients who are pregnant or lactating
• Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient’s ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
• History of allogeneic transplant
• Known HIV or Hepatitis B or C (active, previously treated or both)

If you would like to learn more about participating in this study, please send an e-mail message using the form below.