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

This study has been completed.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00977067
First received: September 12, 2009
Last updated: May 17, 2010
Last verified: May 2010
  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: 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

Resource links provided by NLM:


Further study details as provided by Genentech:

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 ]

Estimated Enrollment: 72
Study Start Date: June 2007
Arms Assigned Interventions
Experimental: A Drug: GDC-0152
Intravenous escalating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00977067

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

No publications provided by Genentech

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00977067     History of Changes
Other Study ID Numbers: IAP4050g
Study First Received: September 12, 2009
Last Updated: May 17, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
GDC0152
IAP
IAP Antagonist

ClinicalTrials.gov processed this record on September 18, 2014