Trial record 1 of 1 for:    GDC-0623
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A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0623 in Patients With Locally Advanced or Metastatic Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01106599
First received: April 16, 2010
Last updated: October 6, 2014
Last verified: October 2014

April 16, 2010
October 6, 2014
April 2010
May 2015   (final data collection date for primary outcome measure)
  • Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Through study completion or early discontinuation ] [ Designated as safety issue: No ]
  • Incidence, nature, and severity of adverse events and serious adverse events, graded according to NCI CTCAE, v4.0 [ Time Frame: Through study completion or early discontinuation ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters of GDC-0623 (total exposure, maximum and minimum plasma concentrations, time to maximum plasma concentration, elimination half-life) [ Time Frame: Through study completion or early discontinuation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01106599 on ClinicalTrials.gov Archive Site
  • Objective response for patients with measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Through study completion or early discontinuation ] [ Designated as safety issue: No ]
  • Duration of objective response for patients with measurable disease according to RECIST [ Time Frame: Through study completion or early discontinuation ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) for patients with measurable disease according to RECIST [ Time Frame: Through study completion or early discontinuation ] [ Designated as safety issue: No ]
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 ]
Not Provided
Not Provided
 
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0623 in Patients With Locally Advanced or Metastatic Solid Tumors
An Open-label, Phase I, Dose Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0623 Administered Daily in Patients With Locally Advanced or Metastatic Solid Tumors

This is an open-label, multicenter, Phase I dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0623 in patients with locally advanced or metastatic solid tumors. Patients will be enrolled in one of two sta ges: a dose-escalation stage (Stage I) followed by an expansion stage (Stage II

). Stage I will evaluate the safety, tolerability, and pharmacokinetics of incr easing doses of GDC-0623 administered orally on a 21 day on/7-day off dosing sch edule.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Cancers
Drug: GDC-0623
Repeating oral dose
Experimental: A
Intervention: Drug: GDC-0623
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
61
May 2015
May 2015   (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 RECIST
  • Life expectancy >= 12 weeks
  • Adequate hematologic and end organ function
  • Agreement to use effective form of contraception for the duration of the study
  • Consent to provide archival tissue
  • For the cohort expansion stage (Stage II): Patients in this cohort must have had no more than four prior systemic therapies for cancer and must have KRAS mutant CRC (Stage II A and B), pancreatic cancer (Stage IIC, or KRAS mutant NSCLC [Stage IID])

Exclusion Criteria:

  • History of prior significant toxicity from a MEK pathway inhibitor requiring discontinuation of treatment
  • History of parathyroid disorder or history of malignancy-associated hypercalcemia requiring therapy in the last 6 months
  • History of retinal vein occlusion (RVO) or predisposing factors to RVO, including uncontrolled hypertension, uncontrolled diabetes, uncontrolled hyperlipidemia, and coagulopathy
  • Evidence of visible retinal pathology considered a risk factor for retinal vein thrombosis
  • History of glaucoma
  • Palliative radiotherapy, experimental therapy, or anti-cancer therapy or major surgical procedure within a specified timeframe prior to first dose of study drug
  • Current severe, uncontrolled systemic disease
  • History of clinically significant cardiac dysfunction
  • History of active gastrointestinal bleeding within 6 months prior to screening
  • Clinically significant history of liver disease, current alcohol abuse, or current known active infection with HIV, or hepatitis B or C virus
  • Active autoimmune disease
  • Uncontrolled ascites
  • Pregnancy, lactation, or breastfeeding
  • Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
  • For the Exploratory PK Cohorts (Stage IB and Stage IC): Patients who have a history of or ongoing gastro-esophageal reflux disease or peptic ulcer, or who have gastric pathology or history of gastric surgery which could affect absorption of GDC-0623 from the stomach, will be excluded from these cohorts
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01106599
MAP4834g, GO01327
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
October 2014

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