Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria

Provision of informed consent
Male or female ≥18 years of age
Histologic or cytologic confirmed diagnosis of small cell lung cancer, either limited or extensive disease at initial presentation is allowed

Evidence of progressive disease during or following 1 or 2 prior chemotherapy regimens

At least 1 prior regimen must have contained a platinum salt
'Adjuvant therapy' will constitute a prior treatment regimen
No more than 2 prior regimens are allowed
Measurable disease (only for the phase II portion)
Eastern Cooperative Oncology Group (ECOG) Performance status 0-1
A minimum life expectancy of 12 weeks

Adequate bone marrow, hepatic and renal function as evidenced by:

Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
Platelet count ≥ 100 x 109/L
Hemoglobin ≥ 9.0 g/dL
Serum bilirubin < 1.5 x ULN
Aspartate aminotransferase (AST)/Alanine transferase (ALT) (SGOT/SGPT) < 2.5 x ULN for the reference laboratory or < 5 x ULN in the presence of liver metastases
Serum creatinine < 1.5 x ULN

No 'active' CNS metastases. Prior CNS metastases are allowed, provided adequate palliative therapy has been administered and CNS disease control has been established prior to study entry.

• A brain MRI scan, ≤ 28 days from day 1, is required

Female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures and who have a negative serum pregnancy test within 1 week prior to initial study treatment. (See Appendix B)
Male patients willing to use adequate contraceptive. (See Appendix B)
At least 21 days must have elapsed prior to day 1 cycle 1, from chemotherapy, radiotherapy, immunotherapy or following major surgery and any surgical incision should be completely healed. At least 14 days must have elapsed prior to Day 1 Cycle 1 for "limited palliative radiotherapy", defined as a course of therapy encompassing < 25% total bone marrow volume and not exceeding 30 Gy.
At least 14 days must have elapsed for chemotherapy regimens, biologic, and targeted therapy given continuously or on a weekly basis with limited potential for delayed toxicity.

Exclusion Criteria:

Patients who are pregnant or breastfeeding.
Active involvement of the Central Nervous System (CNS).
Uncontrolled infection or systemic disease.
Clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease e.g. angina, and cardiac arrhythmias) or myocardial infarction within the last 12 months.
Chemotherapy regimens within the last 21 days (or within 6 weeks for prior nitrosourea or mitomycin C). Chemotherapy regimens, biologic, and targeted therapy given continuously or on a weekly basis with limited potential for delayed toxicity within the last 14 days.
No concurrent systemic chemotherapy or anticancer biologic therapy is allowed. Note: Patients on hormonal treatment for breast cancer or prostate cancer may continue on treatment and enter into study.
Known hypersensitivity to any components of SC16LD6.5 study drug product.
Patients with known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both), a history of solid organ or bone marrow transplantation would generally be considered to have met exclusion criteria, however exceptions may be considered on a case-by-case basis by the medical monitor.
Psychiatric disorder or social or geographic situation that would preclude study participation.
QT interval measurement corrected by Fridericia's formula (QTcF) interval of >450 msec (males) or >470 msec (females)