Trial record 1 of 1 for:    NCT00876109
Previous Study | Return to List | Next Study

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: September 2, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Solid Cancers
Drug: GDC-0941
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 108
Study Start Date: October 2007
Study Completion Date: November 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876109

Locations
United States, Arizona
Scottsdale, Arizona, United States, 85258
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, Michigan
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Genentech
Investigators
Study Director: Gallia Levy, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00876109     History of Changes
Other Study ID Numbers: GDC4255g, GO01300
Study First Received: March 13, 2009
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Metastatic Solid Tumors
PI3K
PI3K Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014