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A Study of GDC-0941 in Patients With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma for Which Standard Therapy Either Does Not Exist or Has Proven Ineffective or Intolerable
This study is currently recruiting participants.
Verified by Genentech, April 2009
First Received: March 13, 2009   Last Updated: April 3, 2009   History of Changes
Sponsored by: Genentech
Information provided by: Genentech
ClinicalTrials.gov Identifier: NCT00876122
  Purpose

This is an open-label, Phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of orally administered GDC-0941. This study will include patients with locally advanced or metastatic solid tumors or Non-Hodgkin's Lymphoma (NHL) for which standard therapy either does not exist or has proven ineffective or intolerable.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Solid Cancers
Drug: GDC-0941
Phase I

MedlinePlus related topics: Cancer Lymphoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment
Official Title: An Open-Label, Phase I, Dose-Escalation Study of PI3-Kinase Inhibitor (GDC-0941) in Patients With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma for Which Standard Therapy Either Does Not Exist or Has Proven Ineffective or Intolerable

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Occurrence of adverse events by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade and associated dose of GDC-0941 [ Time Frame: Through study completion or early study discontinuation ]
  • Occurrence of dose-limiting toxicities (DLTs) by NCI CTCAE grade and associated dose of GDC-0941 [ Time Frame: Through study completion or early study discontinuation ]
  • Occurrence of Grade 3 or 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0941 [ Time Frame: Through study completion or early study discontinuation ]
  • PK parameters after single and multiple doses of GDC-0941 [ Time Frame: Through study completion or early study discontinuation ]

Secondary Outcome Measures:
  • Positron emission tomography (PET) response for patients with detectable Fluorine-18 Deoxyglucose (FDG) tumor uptake at baseline [ Time Frame: Through study completion or early study discontinuation ]
  • Best overall response, duration of objective response, and progression-free survival (PFS) for patients with measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: Through study completion or early study discontinuation ]

Estimated Enrollment: 48
Study Start Date: March 2008
Arms Assigned Interventions
1: Experimental Drug: GDC-0941
Escalating oral dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically documented, incurable, locally advanced, or metastatic solid malignancy, or NHL without leukemic phase, that has progressed or failed to respond to at least one prior regimen
  • Evaluable or measurable disease per RECIST
  • Life expectancy of ≥ 12 weeks
  • Documented willingness to use an effective means of contraception for both men and women while participating in the study

Exclusion Criteria:

  • Leptomeningeal disease as the only manifestation of the current malignancy
  • History of Type 1 or 2 diabetes mellitus requiring regular medication
  • Any condition requiring anti-coagulants, such as warfarin, heparin, or thrombolytics
  • Malabsorption syndrome or other condition that would interfere with enteral absorption
  • Known untreated central nervous system (CNS) malignancies or treated brain metastases that are not radiographically stable for ≥ 3 months
  • Active congestive heart failure or ventricular arrhythmia requiring medication
  • Active infection requiring intravenous (IV) antibiotics
  • Patients requiring any daily supplemental oxygen
  • Uncontrolled hypomagnesemia or hypokalemia, defined as values below the lower limit of normal (LLN) or hypercalcemia above the ULN for the institution despite adequate electrolyte supplementation or management
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Known human immunodeficiency virus (HIV) infection
  • Any other diseases, active or uncontrolled pulmonary dysfunction, 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 patients at high risk from treatment complications
  • Significant traumatic injury within 3 weeks before Day 1
  • Major surgical procedure within 4 weeks prior to initiation of study treatment
  • Treatment with chemotherapy, hormonal therapy (except GnRH agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, or radiation therapy (except palliative radiation to bony metastases) as cancer therapy within 4 weeks prior to initiation of study treatment
  • Palliative radiation to bony metastases within 2 weeks prior to initiation of study treatment
  • Need for chronic corticosteroid therapy
  • Treatment with an investigational agent within 4 weeks prior to initiation of study treatment
  • Unresolved toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy
  • Pregnancy or lactation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876122

Locations
United Kingdom
Royal Marsden Hospital Recruiting
Sutton, United Kingdom, SM25PT
Contact: Krunal Shah     0208 722 4005     Krunal.Shah@icr.ac.uk    
Sponsors and Collaborators
Genentech
Investigators
Study Director: Mika Derynck, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers: GDC4254g
Study First Received: March 13, 2009
Last Updated: April 3, 2009
ClinicalTrials.gov Identifier: NCT00876122     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
NHL
Metastatic Solid Tumors
PI3K Inhibitors
PI3K

Study placed in the following topic categories:
Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:
Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009