A Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0973 in Combination With GDC-0941 When Administered in Patients With Locally Advanced or Metastatic Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00996892
First received: October 12, 2009
Last updated: August 4, 2014
Last verified: August 2014

October 12, 2009
August 4, 2014
November 2009
March 2014   (final data collection date for primary outcome measure)
  • Incidence and nature of dose-limiting toxicities [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • Incidence, nature and severity of adverse events and serious adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • PK parameters of GDC-0941 and GDC-0973 (total exposure, maximum plasma\n\nconcentration, and minimum concentration) [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00996892 on ClinicalTrials.gov Archive Site
Objective 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 ]
  • Objective response [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • Duration of objective response [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0973 in Combination With GDC-0941 When Administered in Patients With Locally Advanced or Metastatic Solid Tumors
A Phase Ib, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0973 in Combination With GDC-0941 When Administered in Patients With Locally Advanced or Metastatic Solid Tumors

This is an open-label, multicenter, Phase Ib dose-escalation study designed to a ssess the safety, tolerability and pharmacokinetics of oral dosing of GDC-0973 a nd GDC-0941 administered in combination in patients with solid tumors.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Cancers
  • Drug: GDC-0941
    Repeating oral dose
  • Drug: GDC-0973/XL518
    Repeating oral dose
Experimental: A
Interventions:
  • Drug: GDC-0941
  • Drug: GDC-0973/XL518
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
179
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically documented, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable
  • Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)
  • Life expectancy >= 12 weeks
  • Adequate hematologic and end organ function
  • Agreement to use an effective form of contraception for the duration of the study

Exclusion Criteria:

  • History of prior significant toxicity from another MEK pathway inhibitor requiring discontinuation of treatment
  • History of prior significant toxicity from another PI3K pathway inhibitor requiring discontinuation of treatment
  • Allergy or hypersensitivity to components of the GDC-0973 or GDC-0941 formulations
  • Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in Cycle 1
  • Experimental therapy within 4 weeks prior to first dose of study drug treatment in Cycle 1
  • Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug treatment in Cycle 1, or anticipation of the need for major surgery during the course of study treatment
  • Prior anti-cancer therapy within 28 days before the first dose of study drug treatment in Cycle 1
  • History of diabetes requiring daily medication, or history of Grade >= 3 fasting hyperglycemia
  • Current severe, uncontrolled systemic disease
  • History of clinically significant cardiac or pulmonary dysfunction
  • History of malabsorption or other condition that would interfere with enteral absorption
  • Clinically significant history of liver disease (including cirrhosis), current alcohol abuse, or current known active infection with HIV, hepatitis B virus, or hepatitis C virus
  • Any condition requiring anticoagulants, such as warfarin, heparin, or thrombolytics
  • Active autoimmune disease
  • Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive weeks prior to enrollment
  • Pregnancy, lactation, or breastfeeding
  • Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
  • No other history of or ongoing malignancy that would potentially interfere with the interpretation of the pharmacodynamic or efficacy assays
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00996892
MEK4752g, GO01330
Not Provided
Genentech
Genentech
Not Provided
Study Director: Iris Chan, M.D., Ph.D. Genentech
Genentech
August 2014

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