Study of GDC-0973/XL518 in Patients With Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00467779
First received: April 18, 2007
Last updated: May 5, 2014
Last verified: May 2014

April 18, 2007
May 5, 2014
April 2009
May 2015   (final data collection date for primary outcome measure)
  • Stage I-II: Safety, tolerability, and maximum tolerated dose of GDC-0973/XL518 [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • Area under the concentration time curve of midazolam [ Time Frame: Cycle 1: Days 1 and 15 ] [ Designated as safety issue: No ]
  • Stage III: Maximum plasma concentration of dextromethorphan [ Time Frame: Cycle 1: Days 1 and 15 ] [ Designated as safety issue: No ]
  • Stage III: Area under the concentration time curve of dextromethorphan [ Time Frame: Cycle 1: Days 1 and 15 ] [ Designated as safety issue: No ]
  • Stage I-II: Maximum tolerated dose of GDC-0973 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Stage III: Maximum plasma concentration of midazolam [ Time Frame: Cycle 1: Days 1 and 15 ] [ Designated as safety issue: No ]
Safety, tolerability, and maximum tolerated dose of XL518
Complete list of historical versions of study NCT00467779 on ClinicalTrials.gov Archive Site
  • Stage I-II: Plasma pharmacokinetics and pharmacodynamic effects of GDC-0973/XL518 [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • Stage III: Safety: incidence of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Plasma pharmacokinetics and pharmacodynamic effects of XL518
Not Provided
Not Provided
 
Study of GDC-0973/XL518 in Patients With Solid Tumors
A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of GDC-0973/XL518 Administered Orally Daily to Subjects With Solid Tumors

This non-randomized, open-label, study will determine the highest safe dose of GDC-0973/XL518, how often it should be taken, how well patients with cancer tolerate GDC-0973/XL518 and will assess the pharmacokinetic effect of midazolam and dextromethorphan on the study drug.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumour
  • Drug: midazolam
    In Stage III only: single dose of midazolam
  • Drug: dextromethorphan
    In Stage III only: single dose of dextromethorphan
  • Drug: GDC-0973/XL518
    Repeating oral dose
Experimental: 1
Interventions:
  • Drug: midazolam
  • Drug: dextromethorphan
  • 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.
 
Active, not recruiting
120
May 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed solid tumor that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival
  • Disease that is measurable according to Response Evaluation Criteria in Solid Tumors (RECIST)
  • Adequate organ and marrow function
  • Sexually active patients must use medically acceptable methods of contraception during the course of the study and at least 11 days after the last dose of study treatment
  • Female patients of childbearing potential must have a negative serum pregnancy test at screening
  • No other history of/or ongoing malignancy that would potentially interfere with the interpretation of the pharmacodynamic or efficacy assays

Exclusion Criteria:

  • Anticancer treatment (e.g., chemotherapy, radiotherapy, cytokines, or hormones) within 28 days (6 weeks for nitrosoureas or mitomycin C, or 14 days for hormonal therapy or kinase inhibitors) before the first dose of study drug
  • The patient has not recovered to Grade </=1 from adverse events (AEs) or to within 10% of baseline values due to investigational or other agents administered more than 28 days prior to study enrollment
  • The patient has received another investigational agent within 28 days of the first dose of study drug
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
  • The patient is pregnant or breastfeeding
  • The patient is known to be positive for the human immunodeficiency virus (HIV)
  • Allergy or hypersensitivity to components of the GDC-0973/XL518 formulation
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00467779
MEK4592g, GO01329, XL518-001
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
May 2014

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