Safety and Pharmacokinetics of Escalating Doses of DNIB0600A in Participants With Non-Small Cell Lung Cancer (NSCLC) and Platinum Resistant Ovarian Cancer

NCT ID: NCT01363947

Last Updated: 2017-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-14
• Study Completion Date: 2016-06-03

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.

Conditions

Non-Small Cell Lung Cancer, Ovarian Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Escalation Cohort (DNIB0600A)

Participants 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.

Group Type: EXPERIMENTAL

DNIB0600A

Intervention Type: DRUG

Several dose levels will be evaluated for DNIB0600A administered via IV infusion on Day 1 of each 21-day cycle until disease progression.

Expansion Cohort (DNIB0600A)

Participants will receive 2.4 mg/kg, by IV infusion, of DNIB0600A q3w for up to 26 cycles.

Group Type: EXPERIMENTAL

DNIB0600A

Intervention Type: DRUG

Several dose levels will be evaluated for DNIB0600A administered via IV infusion on Day 1 of each 21-day cycle until disease progression.

Interventions

DNIB0600A

Several dose levels will be evaluated for DNIB0600A administered via IV infusion on Day 1 of each 21-day cycle until disease progression.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Maslyar, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

HonorHealth Research Institute - Pima Center

Scottsdale, Arizona, United States

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, United States

Sarah Cannon Research Inst.

Nashville, Tennessee, United States

Univ of Texas SW Medical Ctr

Dallas, Texas, United States

Hospital del Mar; Servicio de Oncologia

Barcelona, , Spain

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Barcelona, , Spain

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

Madrid, , Spain

Countries

United States; Spain

Other Identifiers

GO27767

Identifier Type: OTHER

Identifier Source: secondary_id

2014-000527-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DNB4987g

Identifier Type: -

Identifier Source: org_study_id