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

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ClinicalTrials.gov Identifier: NCT00977067
Recruitment Status : Terminated (The study was terminated early by the Sponsor for reasons unrelated to patient safety or anti-tumor activity.)
First Posted : September 15, 2009
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Solid Cancers Drug: GDC-0152 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Actual Study Start Date : June 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Arm Intervention/treatment
Experimental: A Drug: GDC-0152
Intravenous escalating dose




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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.

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 Posted: September 15, 2009    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017

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