Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Cancers

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence and nature of dose-limiting toxicities (DLTs)

Outcome Time Frame:

Through study completion or early discontinuation

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

MAP4834g

NCT ID:

NCT01106599

Start Date:

April 2010

Completion Date:

September 2014

Related Keywords:

  • Solid Cancers

Name

Location

Fountain Valley, California  92708
Nashville, Tennessee  37203-1632
Tulsa, Oklahoma