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

Solid Cancers Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00977067
• Other study ID #: IAP4050g
• Status: Terminated
• Phase: Phase 1
• First received: September 12, 2009
• Last updated: June 20, 2017
• Start date: June 2007
• Est. completion date: November 2009

Study information

• Verified date: June 2017
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Cancers

Intervention

Drug:
• GDC-0152
Intravenous escalating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and nature of dose-limiting toxicities		Through study completion or early study discontinuation
Primary	Incidence, nature, and severity of adverse events		Through study completion or early study discontinuation
Secondary	Pharmacokinetic parameters of GDC-0152 (total plasma exposure, maximum plasma concentration, and total plasma clearance)		Through study completion or early study discontinuation