A Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0917 Administered to Patients With Refractory Solid Tumors or Lymphoma
Primary Purpose
Solid Cancers
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GDC-0917
Sponsored by
About this trial
This is an interventional treatment trial for Solid Cancers
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Changes in vital signs, ECGs, and clinical laboratory results
Incidence and nature of dose-limiting toxicities and adverse events of special interest
Incidence, nature, and severity of all adverse events and serious adverse events
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01226277
Brief Title
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
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Cancers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GDC-0917
Intervention Description
Oral repeating dose
Primary Outcome Measure Information:
Title
Changes in vital signs, ECGs, and clinical laboratory results
Time Frame
Throughout study or until early discontinuation
Title
Incidence and nature of dose-limiting toxicities and adverse events of special interest
Time Frame
Throughout study or until early discontinuation
Title
Incidence, nature, and severity of all adverse events and serious adverse events
Time Frame
Throughout study or until early discontinuation
Secondary Outcome Measure Information:
Title
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)
Time Frame
Throughout study or until early discontinuation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia Portera, M.D., Ph.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
98229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0917 Administered to Patients With Refractory Solid Tumors or Lymphoma
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