Safety and Pharmacokinetics of Escalating Doses of DNIB0600A in Participants With Non-Small Cell Lung Cancer (NSCLC) and Platinum Resistant Ovarian Cancer
Study DNB4987g is a Phase I, multicenter, open label, dose-escalation study of DNIB0600A administered as a single agent by intravenous (IV) infusion every three weeks (q3w) to participants with non-squamous NSCLC or non-mucinous, platinum-resistant ovarian cancer. The study will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.
Checked against the public recordLast updated Jun 7, 2017 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Genentech, Inc.
- Interventions being studied
- Drug: DNIB0600A
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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 human immunodeficiency virus \[HIV\] and atypical mycobacterial disease, but excluding fungal infections of the nail beds) * 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 participant at high risk from treatment complications * 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 * For participants in the second NSCLC cohort expansion, not more than two prior regimens in the metastatic setting * Pregnancy or breast-feeding
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- HonorHealth Research Institute - Pima CenterScottsdale, Arizona
- Smilow Cancer Hospital at Yale New HavenNew Haven, Connecticut
- Sarah Cannon Research Inst.Nashville, Tennessee
- Univ of Texas SW Medical CtrDallas, Texas
- Hospital del Mar; Servicio de OncologiaBarcelona
- Hospital Univ Vall d'Hebron; Servicio de OncologiaBarcelona
- Hospital General Universitario Gregorio Marañon; Servicio de OncologiaMadrid
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 7, 2017. Always confirm current availability with the study team.