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An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0917 Administered Daily in Patients With Refractory Solid Tumors or Lymphoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Cancers

Thank you

Trial Information

An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0917 Administered Daily in Patients With Refractory Solid Tumors or Lymphoma


Inclusion Criteria:



- Histologically or cytologically documented, locally advanced or metastatic solid
tumors or lymphoma for which standard therapy either does not exist or has proven
ineffective or intolerable

- Life expectancy >/= 12 weeks

- Adequate hematologic and end organ function

- For female patients of childbearing potential and male patients with partners of
childbearing potential, agreement (by patient and/or partner) to use an effective
form of contraception and to continue its use for the duration of the study.

Exclusion Criteria:

- Clinically significant history of chronic liver disease, active hepatic infection,
evidence of hepatic cirrhosis or Grade >/= 2 liver dysfunction not due to hepatic
metastases of cancer, current alcohol abuse, active infections with hepatitis B
virus, or hepatitis C virus

- Grade >/= 2 fever or associated constitutional symptoms, or a clinically significant
systemic infection within the last month

- Autoimmune disease

- History of clinically significant pulmonary disease

- Need for chronic and continuous systemic or topical corticosteroids or
immunosuppressive therapy within 2 weeks prior to study entry or anticipated need of
continuous systemic corticosteroids or immunosuppressive therapy during study
participation.

- Allergy or hypersensitivity to components of the GDC-0917 formulation

- 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 4 weeks before the first dose of study drug
treatment in Cycle 1

- All acute drug-related toxicities must have resolved prior to study entry, except for
alopecia and Grade 1 neuropathy.

- Current severe, uncontrolled systemic disease excluding cancer

- History of clinically significant cardiac dysfunction

- History of malabsorption or other condition that would interfere with enteral
absorption

- Any history of active GI bleeding within the past 6 months prior to screening

- Known HIV infection

- Uncontrolled ascites, due to diseases other than cancer, requiring weekly
large-volume paracentesis for 3 consecutive weeks prior to enrollment

- Pregnancy, lactation, breastfeeding or unwillingness to use birth control during the
study and for 3 months after the last dose of GDC-0917

- Known brain metastases that are untreated, symptomatic, or require therapy to control
symptoms

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Changes in vital signs, ECGs, and clinical laboratory results

Outcome Time Frame:

Throughout study or until early discontinuation

Safety Issue:

No

Principal Investigator

Chia Portera, M.D., Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

4914g

NCT ID:

NCT01226277

Start Date:

October 2010

Completion Date:

September 2012

Related Keywords:

  • Solid Cancers
  • Lymphoma

Name

Location

Nashville, Tennessee  37203-1632
Austin, Texas  78705