Trial record 1 of 1 for:    NCT00876109
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A Study of GDC-0941 in Patients With Locally Advanced or Metastatic Solid Tumors for Which Standard Therapy Either Does Not Exist or Has Proven Ineffective or Intolerable

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00876109
First received: March 13, 2009
Last updated: April 7, 2014
Last verified: April 2014

March 13, 2009
April 7, 2014
October 2007
June 2012   (final data collection date for primary outcome measure)
  • Occurrence of adverse events by NCI CTCAE grade and associated dose of GDC-0941 [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • PK parameters after single and multiple doses of GDC-0941 [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • 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 ]
Complete list of historical versions of study NCT00876109 on ClinicalTrials.gov Archive Site
Best overall response, duration of objective response, and progression-free survival (PFS) for patients with measurable disease according to RECIST [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • Cmax and area under the curve (AUC) under fed and fasting conditions [ 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 ]
Not Provided
Not Provided
 
A Study of GDC-0941 in Patients With Locally Advanced or Metastatic Solid Tumors for Which Standard Therapy Either Does Not Exist or Has Proven Ineffective or Intolerable
An Open-Label, Phase I, Dose-Escalation Study Evaluating Two Dosing Schedules of PI3-Kinase Inhibitor (GDC-0941) in Patients With Locally Advanced or Metastatic Solid Tumors for Which Standard Therapy Either Does Not Exist or Has Proven Ineffective or Intolerable

This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of orally administered GDC-0941 administered QD and BID.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Cancers
Drug: GDC-0941
Escalating oral dose
Experimental: 1
Intervention: Drug: GDC-0941
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
November 2013
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically documented, incurable, locally advanced, or metastatic solid malignancy that has progressed or failed to respond to at least one prior regimen. Patients must not be candidates for regimens known to provide clinical benefit.
  • 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
  • Uncontrolled ascites requiring weekly large-volume paracentesis for 3 consecutive weeks prior to enrollment
  • 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 for > 7 days
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00876109
GDC4255g, GO01300
Not Provided
Genentech
Genentech
Not Provided
Study Director: Gallia Levy, M.D. Genentech
Genentech
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP