A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0973 in Combination With GDC-0068 When Administered in Patients With Locally Advanced or Metastatic Solid Tumors

This study is currently recruiting participants.
Verified April 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01562275
First received: March 21, 2012
Last updated: April 7, 2014
Last verified: April 2014

March 21, 2012
April 7, 2014
April 2012
August 2014   (final data collection date for primary outcome measure)
  • Incidence of dose-limiting toxicities [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Nature of dose-limiting toxicities [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Estimation of the maximum tolerated dose [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Nature of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Incidence of serious adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Nature of serious adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Severity of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Severity of serious adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01562275 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic parameters of GDC-0973 and GDC-0068: total exposure [ Time Frame: Days 1, 8, and 15 pre-dose and up to 24 h post-dose for Cycle 1 and Day 1 on Cycles 2 and 3 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters of GDC-0973 and GDC-0068: maximum plasma concentration [ Time Frame: Days 1, 8, and 15 pre-dose and up to 24 h post-dose for Cycle 1 and Day 1 on Cycles 2 and 3 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters of GDC-0973 and GDC-0068: minimum concentration [ Time Frame: Days 1, 8, and 15 pre-dose and up to 24 h post-dose for Cycle 1 and Day 1 on Cycles 2 and 3 ] [ Designated as safety issue: No ]
  • Objective response for patients with measurable disease according to RECIST criteria [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Duration of objective response for patients with measurable disease according to RECIST criteria [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Progression-free survival for patients with measurable disease according to RECIST criteria [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0973 in Combination With GDC-0068 When Administered in Patients With Locally Advanced or Metastatic Solid Tumors
A Phase Ib, Open-Label, Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of GDC-0973 and GDC-0068 in Patients With Locally Advanced or Metastatic Solid Tumors

This open-label, multicenter, Phase Ib dose-escalation study will evaluate the safety, tolerability and pharmacokinetics of oral dosing of GDC-0973 and GDC-0068 administered in combination in patients with locally advanced or metastatic solid tumors. Cohorts of patients will receive multiple ascending doses of GDC-0973 and GDC-0068. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
  • Drug: GDC-0973
    multiple doses
  • Drug: GDC-0068
    multiple doses
  • Experimental: A
    Interventions:
    • Drug: GDC-0973
    • Drug: GDC-0068
  • Experimental: B
    Interventions:
    • Drug: GDC-0973
    • Drug: GDC-0068
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
108
August 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically documented locally advanced or metastatic solid tumors for which standard therapies either do not exist or have 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

Exclusion Criteria:

  • History of prior significant toxicity from another MEK pathway inhibitor requiring discontinuation of treatment
  • History of prior significant toxicity from another PI3K or Akt pathway or mTOR inhibitor requiring discontinuation of treatment
  • Anti-cancer therapy within 28 days prior to first dose of study drug, except as stated in protocol
  • History of type I or type II diabetes mellitus requiring insulin
  • Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease)
  • Clinically significant history of liver disease, current alcohol abuse, or current known active infection with HIV, hepatitis B or hepatitis C virus
  • Active autoimmune disease
  • Pregnant or lactating women
  • Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
  • History of glaucoma
  • History of retinal vein occlusion
Both
18 Years and older
No
Contact: Reference Study ID Number: GE28079 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   Spain
 
NCT01562275
GE28079
Not Provided
Genentech
Genentech
Not Provided
Study Director: Clinical Trials Genentech
Genentech
April 2014

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