Safety and Pharmacokinetics of Escalating Doses of DNIB0600A in Participants With Non-Small Cell Lung Cancer (NSCLC) and Platinum Resistant Ovarian Cancer
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
3 other identifiers
interventional
87
2 countries
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2011
Longer than P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2011
CompletedFirst Posted
Study publicly available on registry
June 2, 2011
CompletedStudy Start
First participant enrolled
June 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2016
CompletedJune 7, 2017
June 1, 2017
5 years
May 26, 2011
June 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of causality.
Up to approximately 2 years
Secondary Outcomes (4)
Cmax of DNIB0600A for Antibody-Conjugated Monomethyl Auristatin E (acMMAE), Total Antibody, and Unconjugated Monomethyl Auristatin E (MMAE)
Day 21
Percentage of Participants with Antibody Formation to DNIB0600A
Up to approximately 84 weeks
Percentage of Participants with Objective Response (OR)
Up to approximately 84 weeks
Duration of Objective Response (DOR)
Up to approximately 84 weeks
Study Arms (2)
Dose Escalation Cohort (DNIB0600A)
EXPERIMENTALParticipants will receive IV infusions of DNIB0600A at doses ranging from 0.2 milligrams/kilogram (mg/kg) to 2.8 mg/kg q3w until dose-limiting toxicity (DLT) is reached, or up to 28 cycles.
Expansion Cohort (DNIB0600A)
EXPERIMENTALParticipants will receive 2.4 mg/kg, by IV infusion, of DNIB0600A q3w for up to 26 cycles.
Interventions
Several dose levels will be evaluated for DNIB0600A administered via IV infusion on Day 1 of each 21-day cycle until disease progression.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (7)
HonorHealth Research Institute - Pima Center
Scottsdale, Arizona, 85258, United States
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, 06510, United States
Sarah Cannon Research Inst.
Nashville, Tennessee, 37203, United States
Univ of Texas SW Medical Ctr
Dallas, Texas, 75390, United States
Hospital del Mar; Servicio de Oncologia
Barcelona, 08003, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, 08035, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, 28007, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Daniel Maslyar, M.D.
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2011
First Posted
June 2, 2011
Study Start
June 14, 2011
Primary Completion
June 3, 2016
Study Completion
June 3, 2016
Last Updated
June 7, 2017
Record last verified: 2017-06