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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01363947
First received: May 26, 2011
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

Study DNB4987g is a Phase I, multicenter, open label, dose-escalation study of D NIB0600A 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-Small Cell Lung Cancer, Ovarian Cancer
Drug: DNIB0600A
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
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 ] [ Designated as safety issue: No ]
  • Nature of dose limiting toxicities (DLTs) by NCI CTCAE, v4.0, grading scale [ Time Frame: Days 1-21 of Cycle 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total exposure (area under the concentration-time curve) [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Pharmacokinetic property of DNIB0600A: maximum concentrations [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Pharmacokinetic property of DNIB0600A: minimum concentrations [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Pharmacokinetic property of DNIB0600A: clearance [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: June 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: DNIB0600A
Intravenous escalating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 ClinicalTrials.gov identifier: NCT01363947

Contacts
Contact: Reference Study ID Number: DNB4987g www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

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

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01363947     History of Changes
Other Study ID Numbers: DNB4987g, GO27767
Study First Received: May 26, 2011
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014