A Study Evaluating GDC-0980 Administered Once Daily in Patients With Refractory Solid Tumors or Non-Hodgkin's Lymphoma
This study is currently recruiting participants.
Verified May 2012 by Genentech
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00854152
First received: February 27, 2009
Last updated: May 8, 2012
Last verified: May 2012
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Purpose
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.
Condition | Intervention | Phase |
---|---|---|
Non-Hodgkin's Lymphoma, Solid Cancers |
Drug: GDC-0980 |
Phase 1 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | An Open-label, Phase I, Dose-Escalation Study Evaluating the Safety, Tolerability, and Maximally Tolerated Dose of GDC-0980 Administered Once Daily in Patients With Refractory Solid Tumors and Non-Hodgkin's Lymphoma |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- Occurrence of adverse events [ Time Frame: Length of study ] [ Designated as safety issue: No ]
- Occurrence of dose-limiting toxicities [ Time Frame: Length of study ] [ Designated as safety issue: No ]
- PK parameters after doses of GDC-0980 [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Cmax and AUC under fed and fasting conditions [ Time Frame: Length of study ] [ Designated as safety issue: No ]
- Best overall response, duration of objective response, and progression-free survival for patients with measurable disease [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Estimated Enrollment: | 105 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | October 2014 |
Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: 1 |
Drug: GDC-0980
Escalating repeating dose
|
Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
- ECOG performance status of 0 or 1 at screening
- 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.
- Life expectancy >=12 weeks
- Adequate hematologic and organ function within 14 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
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
- Ejection fraction that is <50% or below the LLN (whichever is higher), as determined by echocardiogram or MUGA scan
- DLCO < 50% of predicted value corrected for hemoglobin and alveolar volume prior to initiation of GDC-0980
- 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
- Active congestive heart failure or ventricular arrhythmia requiring medication
- Active infection requiring IV antibiotics
- Requirement for any daily supplemental oxygen
- 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
- Significant traumatic injury within 4 weeks of Day 1
- Major surgical procedure within 4 weeks prior to initiation of GDC-0980
- For all patients participating in Stage 2: Prior treatment with any PI3K inhibitor, mTOR inhibitor or dual PI3K/mTOR inhibitor. For HNSCC patients, this restriction applies only to any PI3K inhibitor, mTOR inhibitor, or dual PI3K/mTOR inhibitor used in the palliative setting.
- 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
- For patients with advanced solid tumors or NHL participating in the PPI-effect assessment: Known hypersensitivity to rabeprazole, substituted benzimidazoles, or to any component of the formulation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00854152
Contacts
Contact: Please reference Study ID Number: PIM4604g | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
United States, Illinois | |
Not yet recruiting | |
Chicago, Illinois, United States, 60637 | |
United States, Massachusetts | |
Recruiting | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
Not yet recruiting | |
New York, New York, United States, 10065 | |
United States, Tennessee | |
Recruiting | |
Nashville, Tennessee, United States, 37203 | |
United Kingdom | |
Recruiting | |
Sutton, United Kingdom, SM2 5PT |
Sponsors and Collaborators
Genentech
Investigators
Study Director: | Mika Derynck, M.D. | Genentech |
More Information
No publications provided
Keywords provided by Genentech:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 26, 2012
No publications provided
Responsible Party: | Genentech |
ClinicalTrials.gov Identifier: | NCT00854152 History of Changes |
Other Study ID Numbers: | PIM4604g, MP00880 |
Study First Received: | February 27, 2009 |
Last Updated: | May 8, 2012 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Genentech:
NHL Tumors Carcinogenic Tumors |
Additional relevant MeSH terms:
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on September 26, 2012