Clinical trial NCT01363947: Safety and Pharmacokinetics of Escalating Doses of DNIB0600A in Participants With Non-Small Cell Lung Cancer (NSCLC) and Platinum Resistant Ovarian Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Small Cell Lung Cancer, Ovarian Cancer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-02
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Cmax of DNIB0600A for Antibody-Conjugated Monomethyl Auristatin E (acMMAE), Total Antibody, and Unconjugated Monomethyl Auristatin E (MMAE)
timeFrame: Day 21
measure: Percentage of Participants with Antibody Formation to DNIB0600A
timeFrame: Up to approximately 84 weeks
measure: Percentage of Participants with Objective Response (OR)
timeFrame: Up to approximately 84 weeks
measure: Duration of Objective Response (DOR)
timeFrame: Up to approximately 84 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Research Institute - Pima Center
state: Arizona
city: New Haven
country: United States
facility: Smilow Cancer Hospital at Yale New Haven
state: Connecticut
city: Nashville
country: United States
facility: Sarah Cannon Research Inst.
state: Tennessee
city: Dallas
country: United States
facility: Univ of Texas SW Medical Ctr
state: Texas
city: Barcelona
country: Spain
facility: Hospital del Mar; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Study officials:
affiliation: Genentech, Inc.
name: Daniel Maslyar, M.D.
role: STUDY_DIRECTOR
References: