Trial record 1 of 1 for:    NCT00876109
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A Study of GDC-0941 in Participants 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, Inc.
ClinicalTrials.gov Identifier:
NCT00876109
First received: March 13, 2009
Last updated: July 1, 2016
Last verified: July 2016

March 13, 2009
July 1, 2016
October 2007
June 2012   (final data collection date for primary outcome measure)
  • Maximum Observed Concentration (Cmax) of GDC-0941 [ Time Frame: Pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72 h) Day 1; pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24 h) Days 8 and 15; pre-dose (5 min) Days 22, 29, 36, and end of Cycles 1 to 12 (up to 1 year overall) ] [ Designated as safety issue: No ]
  • Terminal Elimination Half-Life (t1/2) of GDC-0941 [ Time Frame: Pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72 h) Day 1; pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24 h) Days 8 and 15; pre-dose (5 min) Days 22, 29, 36, and end of Cycles 1 to 12 (up to 1 year overall) ] [ Designated as safety issue: No ]
  • Area Under the Concentration-Time Curve (AUC) of GDC-0941 [ Time Frame: Pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72 h) Day 1; pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24 h) Days 8 and 15; pre-dose (5 min) Days 22, 29, 36, and end of Cycles 1 to 12 (up to 1 year overall) ] [ Designated as safety issue: No ]
  • Percentage of Participants with Adverse Events [ Time Frame: Visits during treatment on Days 1, 2, 3, 4, 8, 15, 22, 29, 36; weekly during Cycle 2; every two weeks during Cycles 3 to 6; every month during Cycles 7 to 12; and up to 30 days after last dose (up to 1 year overall) ] [ Designated as safety issue: No ]
  • Percentage of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Visits during treatment on Days 1, 2, 3, 4, 8, 15, 22, 29, 36 ] [ Designated as safety issue: No ]
  • Percentage of Participants with Grade 3 or 4 Abnormalities in Safety-Related Laboratory Parameters [ Time Frame: Visits at Baseline and during treatment on Days 1, 8, 15, 22, 29, 36; weekly during Cycle 2; every two weeks during Cycles 3 to 6; every month during Cycles 7 to 12; and up to 30 days after last dose (up to 1 year overall) ] [ Designated as safety issue: No ]
  • Time of Maximum Observed Concentration (Tmax) of GDC-0941 [ Time Frame: Pre-dose (5 minutes [min]) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72 hours [h]) Day 1; pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24 h) Days 8 and 15; pre-dose (5 min) Days 22, 29, 36, and end of Cycles 1 to 12 (up to 1 year overall) ] [ 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
  • Duration of Objective Response According to RECIST [ Time Frame: Tumor assessments as Baseline, Day 36, and every 8 weeks thereafter through Cycle 12 (up to 1 year overall) ] [ Designated as safety issue: No ]
  • Progression-Free Survival (PFS) According to RECIST [ Time Frame: Tumor assessments as Baseline, Day 36, and every 8 weeks thereafter through Cycle 12 (up to 1 year overall) ] [ Designated as safety issue: No ]
  • Percentage of Participants by Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Tumor assessments as Baseline, Day 36, and every 8 weeks thereafter through Cycle 12 (up to 1 year overall) ] [ 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 Participants 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 once daily (QD) and twice daily (BID) in the treatment of advanced or metastatic solid tumors.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Solid Cancers
Drug: GDC-0941
GDC-0941 will be administered in escalating oral doses QD or BID in Groups A and B, respectively. In Group C, the dose/regimen will be determined on the basis of data from Groups A and B. The overall starting dose will be 15 mg administered in the first cohort enrolled in Group A.
Other Name: PI3-Kinase Inhibitor
  • Experimental: Group A: GDC-0941 QD Dose Escalation
    Participants will receive GDC-0941 for up to 1 year, administered orally QD at a starting dose of 15 milligrams (mg).
    Intervention: Drug: GDC-0941
  • Experimental: Group B: GDC-0941 BID Dose Escalation
    Participants will receive GDC-0941 for up to 1 year, administered orally BID at a starting dose determined from Group A assessments.
    Intervention: Drug: GDC-0941
  • Experimental: Group C: GDC-0941 QD or BID Expansion
    Participants will receive GDC-0941 for up to 1 year, administered orally QD or BID. The dose/regimen will be determined on the basis of data from Groups A and B.
    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:

  • Participants with histologically documented, incurable, locally advanced or metastatic solid malignancy that has progressed or failed to respond to at least one prior regimen, and who are not candidates for regimens known to provide clinical benefit
  • Evaluable or measurable disease per RECIST
  • Life expectancy of greater than or equal to (>/=) 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 anticoagulants, 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
  • Requirement for any daily supplemental oxygen
  • Uncontrolled hypomagnesemia or hypokalemia, defined as values below the lower limit of normal (LLN), or hypercalcemia above the upper limit of normal (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 participant 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 gonadotropin releasing hormone [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 greater than (>) 7 days
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00876109
GDC4255g, GO01300
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Jerry Hsu, M.D. Genentech, Inc.
Genentech, Inc.
July 2016

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