A Study Evaluating GDC-0980 Administered Once Weekly in Patients With Refractory Solid Tumors or Non-Hodgkin's Lymphoma
Primary Purpose
Non-Hodgkin's Lymphoma, Solid Cancers
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
GDC-0980
Sponsored by
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma, Solid Cancers focused on measuring NHL, Solid Tumors, Carcinogenic Tumors
Eligibility Criteria
Inclusion Criteria:
- Histologically documented, incurable, locally advanced or metastatic solid malignancies, or NHL without leukemic phase, that has progressed despite standard of care therapy or for which there is no standard therapy of proven clinical benefit
- A biopsy-accessible lesion from which tissue can be obtained safely
- Evaluable or measurable disease per RECIST and/or the following: prostate cancer patients with non-measurable disease are eligible if they have two rising prostate-specific antigen (PSA) levels that meet the PSA Working Group criteria for progression prior to initiation of study treatment; ovarian cancer patients with non-measurable disease are eligible if they have two rising CA-125 levels greater than the ULN >= 2 weeks apart prior to initiation of study treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
- Life expectancy >= 12 weeks
- Adequate hematologic and organ function within 28 days before initiation of GDC-0980
- Documented willingness to use an effective means of contraception for both men and women while participating in the study
- For patients participating in DCE-MRI assessments: at least one metastatic lesion measuring >/= 3 cm in the liver or >/= 2 cm elsewhere (lung and mediastinum lesions are ineligible) in at least one dimension (on CT scan)
Exclusion Criteria:
- Leptomeningeal disease as the only manifestation of the current malignancy
- History of Type 1 or 2 diabetes mellitus requiring regular medication
- Grade >=2 hypercholesterolemia or hypertriglyceridemia
- Malabsorption syndrome or other condition that would interfere with enteral absorption
- Known untreated malignancies of the brain or spinal cord, or treated brain metastases that are not radiographically stable for >= 3 months
- Congenital long QT syndrome or screening QTc > 470 msec
- Active congestive heart failure or ventricular arrhythmia requiring medication
- Ejection fraction that is <50% or is below the LLN (whichever is higher), as determined by echocardiogram or MUGA scan
- Active infection requiring IV antibiotics
- Requirement for any daily supplemental oxygen
- DLCO < 50% of predicted value corrected for hemoglobin and alveolar volume
- Uncontrolled hypomagnesemia
- Hypercalcemia requiring continued use of bisphosphonate therapy
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- Uncontrolled ascites requiring frequent paracentesis
- Known HIV infection
- Any other diseases, active or controlled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patients at high risk from treatment complications
- Significant traumatic injury within 4 weeks of Day 1
- Major surgical procedure within 4 weeks prior to initiation of GDC-0980
- Treatment with chemotherapy, hormonal therapy (except hormone replacement therapy, oral contraceptives, or GnRH agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, radiation therapy (except palliative radiation to bony metastases), or herbal therapy as cancer therapy within 3 weeks prior to initiation of GDC-0980
- Palliative radiation to bony metastases within 2 weeks prior to initiation of GDC-0980
- Need for chronic corticosteroid therapy of >=10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressant
- Treatment with an investigational agent within 4 weeks prior to initiation of GDC-0980
- Unresolved toxicity from prior therapy except for alopecia and Grade 1 peripheral neuropathy
- Pregnancy or lactation
- For patients participating in DCE-MRI assessments, any contraindication to MRI examination
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Occurrence of adverse events
Occurrence of dose-limiting toxicities
Occurrence of Grade 3 and 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0980
PK parameters after doses of GDC-0980
Secondary Outcome Measures
Best overall response, duration of objective response, and progression-free survival for patients with measurable disease according to RECIST
PET response for patients with detectable FDG tumor uptake at baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00854126
Brief Title
A Study Evaluating GDC-0980 Administered Once Weekly in Patients With Refractory Solid Tumors or Non-Hodgkin's Lymphoma
Official Title
An Open-label, Phase I, Dose-escalation Study Evaluating GDC-0980 Administered Once Weekly in Patients With Refractory Solid Tumors and Non-hodgkin's Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 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 study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0980 administered to patients with incurable, locally advanced or metastatic solid malignancy or NHL that has progressed or failed to respond to at least one prior regimen or for which there is no standard therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma, Solid Cancers
Keywords
NHL, Solid Tumors, Carcinogenic Tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GDC-0980
Intervention Description
Escalating repeating dose
Primary Outcome Measure Information:
Title
Occurrence of adverse events
Time Frame
Length of study
Title
Occurrence of dose-limiting toxicities
Time Frame
Length of study
Title
Occurrence of Grade 3 and 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0980
Time Frame
Length of study
Title
PK parameters after doses of GDC-0980
Time Frame
Length of study
Secondary Outcome Measure Information:
Title
Best overall response, duration of objective response, and progression-free survival for patients with measurable disease according to RECIST
Time Frame
Length of study
Title
PET response for patients with detectable FDG tumor uptake at baseline
Time Frame
Length of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically documented, incurable, locally advanced or metastatic solid malignancies, or NHL without leukemic phase, that has progressed despite standard of care therapy or for which there is no standard therapy of proven clinical benefit
A biopsy-accessible lesion from which tissue can be obtained safely
Evaluable or measurable disease per RECIST and/or the following: prostate cancer patients with non-measurable disease are eligible if they have two rising prostate-specific antigen (PSA) levels that meet the PSA Working Group criteria for progression prior to initiation of study treatment; ovarian cancer patients with non-measurable disease are eligible if they have two rising CA-125 levels greater than the ULN >= 2 weeks apart prior to initiation of study treatment.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
Life expectancy >= 12 weeks
Adequate hematologic and organ function within 28 days before initiation of GDC-0980
Documented willingness to use an effective means of contraception for both men and women while participating in the study
For patients participating in DCE-MRI assessments: at least one metastatic lesion measuring >/= 3 cm in the liver or >/= 2 cm elsewhere (lung and mediastinum lesions are ineligible) in at least one dimension (on CT scan)
Exclusion Criteria:
Leptomeningeal disease as the only manifestation of the current malignancy
History of Type 1 or 2 diabetes mellitus requiring regular medication
Grade >=2 hypercholesterolemia or hypertriglyceridemia
Malabsorption syndrome or other condition that would interfere with enteral absorption
Known untreated malignancies of the brain or spinal cord, or treated brain metastases that are not radiographically stable for >= 3 months
Congenital long QT syndrome or screening QTc > 470 msec
Active congestive heart failure or ventricular arrhythmia requiring medication
Ejection fraction that is <50% or is below the LLN (whichever is higher), as determined by echocardiogram or MUGA scan
Active infection requiring IV antibiotics
Requirement for any daily supplemental oxygen
DLCO < 50% of predicted value corrected for hemoglobin and alveolar volume
Uncontrolled hypomagnesemia
Hypercalcemia requiring continued use of bisphosphonate therapy
Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
Uncontrolled ascites requiring frequent paracentesis
Known HIV infection
Any other diseases, active or controlled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patients at high risk from treatment complications
Significant traumatic injury within 4 weeks of Day 1
Major surgical procedure within 4 weeks prior to initiation of GDC-0980
Treatment with chemotherapy, hormonal therapy (except hormone replacement therapy, oral contraceptives, or GnRH agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, radiation therapy (except palliative radiation to bony metastases), or herbal therapy as cancer therapy within 3 weeks prior to initiation of GDC-0980
Palliative radiation to bony metastases within 2 weeks prior to initiation of GDC-0980
Need for chronic corticosteroid therapy of >=10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressant
Treatment with an investigational agent within 4 weeks prior to initiation of GDC-0980
Unresolved toxicity from prior therapy except for alopecia and Grade 1 peripheral neuropathy
Pregnancy or lactation
For patients participating in DCE-MRI assessments, any contraindication to MRI examination
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mika Derynck, M.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Villejuif
ZIP/Postal Code
94805
Country
France
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
12. IPD Sharing Statement
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A Study Evaluating GDC-0980 Administered Once Weekly in Patients With Refractory Solid Tumors or Non-Hodgkin's Lymphoma
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