Safety and Pharmacokinetics of Escalating Doses of DNIB0600A in Patients With Non-Small Cell Lung Cancer and Platinum Resistant Ovarian Cancer

Study ID

Cancer Related

Healthy Volunteers

Study Sites

  • Clements University Hospital
  • UT Southwestern Ambulatory Services
  • Zale Lipshy University Hospital

Joyce Bolluyt

Principal Investigator
David Gerber, M.D.

Official Title

A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DNIB0600A in Patients With Non-Small Cell Lung Cancer and Platinum-Resistant Ovarian Cancer

Brief Overview

Study DNB4987g is a Phase I, multicenter, open label, dose-escalation study of DNIB0600A
administered as a single agent by intravenous (IV) infusion to patients with non-squamous
NSCLC or non-mucinous, platinum resistant ovarian cancer.

Participant Eligibility

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Histologic documentation of incurable, locally advanced or metastatic disease that
has failed prior chemotherapy and for which no standard therapy exists, including the
following: non-squamous NSCLC or non-mucinous and platinum-resistant ovarian cancer

- Availability and willingness to provide an adequate archival sample of tumor

- Measurable disease

- For fertile men or women of childbearing potential, documented willingness to use a
highly effective means of contraception

Exclusion Criteria:

- Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal
therapy within 4 weeks prior to study treatment

- Major surgical procedure within 4 weeks prior to study treatment

- Known active bacterial, viral, fungal, mycobacterial, or other infection (including
HIV and atypical mycobacterial disease, but excluding fungal infections of the nail

- Clinically significant history of liver disease, including viral or other hepatitis,
current alcohol abuse, or cirrhosis

- Untreated or active central nervous system (CNS) metastases

- Requirement for supplemental oxygen to carry out activities of daily living

- Any other diseases, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the patient at high risk from treatment

- Evidence of significant uncontrolled concomitant diseases, such as cardiovascular
disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal
disorders; or a serious non-healing wound or fracture

- Pregnancy or breast-feeding