We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of the Safety and Pharmacokinetics of GDC-0152, Administered Intravenously to Patients With Locally Advanced or Metastatic Malignancies

This study has been terminated.
(The study was terminated early by the Sponsor for reasons unrelated to patient safety or anti-tumor activity.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00977067
First Posted: September 15, 2009
Last Update Posted: June 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
  Purpose
The study consists of two stages. In Stage 1, maximum tolerated dose (MTD) will be determined. In Stage 2, additional patients will be treated at the MTD of GDC-0152.

Condition Intervention Phase
Solid Cancers Drug: GDC-0152 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ia, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of GDC-0152, an IAP Protein Antagonist, Administered Intravenously to Patients With Locally Advanced or Metastatic Malignancies

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Incidence and nature of dose-limiting toxicities [ Time Frame: Through study completion or early study discontinuation ]
  • Incidence, nature, and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters of GDC-0152 (total plasma exposure, maximum plasma concentration, and total plasma clearance) [ Time Frame: Through study completion or early study discontinuation ]

Enrollment: 40
Actual Study Start Date: June 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: GDC-0152
Intravenous escalating dose

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria

  • Histologically documented, incurable, locally advanced or metastatic solid malignancies, or non-Hodgkin's lymphoma (NHL) without leukemic phase
  • Disease (either target or non-target lesions) that can be assessed by imaging studies and/or physical examination
  • For patients with solid tumors or NHL without leukemic phase, disease progression on or after standard therapy, or a malignancy for which there is no standard therapy
  • All prior therapy-related toxicities have recovered to baseline-grade toxicity with the exception of alopecia.
  • Life expectancy of ≥ 60 days
  • Resting oxygen saturation ≥ 92% on room air
  • Agreement to use an effective form of contraception for the duration of the study

Exclusion Criteria

  • History of central nervous system disease
  • Chemotherapy, cancer hormonal therapy (except GnRH agonists), radiotherapy, or immunotherapy within 4 weeks prior to Day 1 (6 weeks for nitrosoureas or mitomycin)
  • Use of any other investigational agent or device
  • Major surgery or significant traumatic injury within 3 weeks prior to Day 1
  • Pregnant or nursing
  • Clinically significant cardiovascular disease, New York Heart Association (NYHA) Classification Grade 2 or greater congestive heart failure, a ventricular arrhythmia requiring medication within 1 year prior to Day 1, or NYHA Grade 2 or greater peripheral vascular disease on Day 1
  • Known HIV infection
  • Patients with ongoing inflammatory processes or a Grade ≥ 2 fever or Grade ≥ 2 fever-associated constitutional symptoms (including rigors/chills, sweating, and others determined by the investigator), or a clinically significant systemic infection within the last month
  • 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 renders the patient at high risk from treatment complications
  • History of any chronic liver disease, active hepatic infection, or evidence of hepatic cirrhosis, or Grade ≥ 2 liver dysfunction.
  • Baseline oxygen requirement or history of pulmonary fibrosis
  • Any signs or symptoms Grade ≥ 2 by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0, at study entry except for alopecia, pain, asymptomatic Grade 2 diffusing capacity of the lung for carbon monoxide (at the discretion of the investigator) or where otherwise specified
  • Patients who need to take a concomitant medication, dietary supplement, or food that is a known inhibitor/inducer of the CYP3A4/5 and/or the 2C8 metabolic pathway or that has a narrow therapeutic window and involves these enzymes for their metabolism
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00977067


Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Iris Chan, M.D., Ph.D. Genentech, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00977067     History of Changes
Other Study ID Numbers: IAP4050g
First Submitted: September 12, 2009
First Posted: September 15, 2009
Last Update Posted: June 21, 2017
Last Verified: June 2017

Keywords provided by Genentech, Inc.:
GDC0152
IAP
IAP Antagonist