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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Cancers

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence and nature of dose-limiting toxicities

Outcome Time Frame:

Through study completion or early study discontinuation

Principal Investigator

Iris Chan, M.D., Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

IAP4050g

NCT ID:

NCT00977067

Start Date:

June 2007

Completion Date:

Related Keywords:

  • Solid Cancers
  • GDC0152
  • IAP
  • IAP Antagonist

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