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

This study has been completed.
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: May 26, 2011
Last updated: November 1, 2016
Last verified: November 2016
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.

Condition Intervention Phase
Non-Squamous Non-Small Cell Lung Cancer, Ovarian Cancer
Drug: DNIB0600A
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Incidence of dose limiting toxicities (DLTs) by NCI CTCAE, v4.0, grading scale [ Time Frame: Days 1-21 of Cycle 1 ]
  • Nature of dose limiting toxicities (DLTs) by NCI CTCAE, v4.0, grading scale [ Time Frame: Days 1-21 of Cycle 1 ]

Secondary Outcome Measures:
  • Total exposure (area under the concentration-time curve) [ Time Frame: Up to 1 year ]
  • Pharmacokinetic property of DNIB0600A: maximum concentrations [ Time Frame: Up to 1 year ]
  • Pharmacokinetic property of DNIB0600A: minimum concentrations [ Time Frame: Up to 1 year ]
  • Pharmacokinetic property of DNIB0600A: clearance [ Time Frame: Up to 1 year ]

Enrollment: 87
Study Start Date: June 2011
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: DNIB0600A
Intravenous escalating dose


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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 patient 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
  • Pregnancy or breast-feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01363947

United States, Arizona
Scottsdale, Arizona, United States, 85258
United States, Connecticut
New Haven, Connecticut, United States, 06510
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Dallas, Texas, United States, 75390
Barcelona, Spain, 08003
Barcelona, Spain, 08035
Madrid, Spain, 28007
Sponsors and Collaborators
Genentech, Inc.
Study Director: Daniel Maslyar, M.D. Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc. Identifier: NCT01363947     History of Changes
Other Study ID Numbers: DNB4987g
GO27767 ( Other Identifier: Hoffmann-La Roche )
Study First Received: May 26, 2011
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Ovarian Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders processed this record on May 25, 2017