Clinical trial NCT01226277: A Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0917 Administered to Patients With Refractory Solid Tumors or Lymphoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Cancers
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2010-10-22
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, multicenter, Phase I dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics (PK) of GDC-0917 in patients with refractory solid tumors or lymphoma.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in vital signs, ECGs, and clinical laboratory results
timeFrame: Throughout study or until early discontinuation
measure: Incidence and nature of dose-limiting toxicities and adverse events of special interest
timeFrame: Throughout study or until early discontinuation
measure: Incidence, nature, and severity of all adverse events and serious adverse events
timeFrame: Throughout study or until early discontinuation
Secondary outcomes:
measure: Pharmacokinetic parameters of GDC-0917 (including total exposure, maximum and minimum serum concentration, time to maximum observed plasma concentration, elimination of half-life, accumulation at steady-state)
timeFrame: Throughout study or until early discontinuation
Other outcomes:
Locations:
city: Nashville
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Genentech, Inc.
name: Chia Portera, M.D., Ph.D.
role: STUDY_DIRECTOR
References: