Status:
COMPLETED
A Study of GDC-0941 in Patients With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma for Which Standard Therapy Either Does Not Exist or Has Proven Ineffective or Intolerable
Lead Sponsor:
Genentech, Inc.
Conditions:
Non-Hodgkin's Lymphoma, Solid Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open-label, Phase I, dose-escalation study using a 3 + 3 design to assess the safety, tolerability, and pharmacokinetics of orally administered GDC-0941 administered QD. This study will inc...
Eligibility Criteria
Inclusion
- Histologically or cytologically documented, incurable, locally advanced or metastatic solid malignancy or NHL without leukemic phase that has progressed or has failed to respond to at least one prior regimen
- Multiple myeloma (MM) patients (only in Stage 2): documented pathologic diagnosis of MM that has relapsed or that has failed to respond after treatment with at least one prior systemic therapy (other than corticosteroid monotherapy)
- Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) or per International Working Group (IWG) response criteria for Non-Hodgkin's lymphoma (NHL) patients
- Life expectancy of \>= 12 weeks
- Documented willingness to use an effective means of contraception for both men and women while participating in the study
- For patients participating in Stage 1 after an adequate exposure has been predicted or observed on the basis of PK analysis and for approximately 12 patients participating in Stage 2 (excluding patients with MM): A biopsy-accessible lesion from which tissue can be obtained safely with CT guidance or direct visualization and agreement from the patient to undergo sequential (pre-treatment and post-treatment) biopsies.
- For patients participating in Stage 2 DCE-MRI and MRS imaging: Patients will have at least one metastatic liver lesion measuring \>= 5 cm in one dimension or one tumor lesion elsewhere measuring \>= 2 cm in one dimension (lung and mediastinum lesions do not qualify) on the basis of CT scans
Exclusion
- Leptomeningeal disease as the only manifestation of the current malignancy
- History of Type 1 or 2 diabetes mellitus requiring regular medication
- Any condition requiring anti-coagulants, such as warfarin, heparin, or thrombolytics
- Inability or unwillingness to swallow pills
- Malabsorption syndrome or other condition that would interfere with enteral absorption
- Known untreated CNS malignancies or treated brain metastases that are not radiographically stable for \>= 3 months
- Congenital long QT syndrome or QTc \> 500 msec, as determined by at least two of the three baseline ECG measurements
- Active congestive heart failure or ventricular arrhythmia requiring medication
- Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive weeks prior to enrollment
- Active infection requiring intravenous (IV) antibiotics
- Patients requiring any daily supplemental oxygen
- DLco, 50% predicted value corrected for AV and Hgb prior to initiation of study treatment
- Uncontrolled hypomagnesemia or hypokalemia, defined as values below the lower limit of normal (LLN) or hypercalcemia above the ULN for the institution despite adequate electrolyte supplementation or management
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- Known human immunodeficiency virus (HIV) infection
- Any other diseases, active or uncontrolled 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 3 weeks before Day 1
- Major surgical procedure within 4 weeks prior to initiation of study treatment
- Prior allogeneic hematopoietic stem cell transplantation (HSCT) at any time or autologous HSCT within 12 weeks of study entry
- Treatment with chemotherapy, hormonal therapy (except GnRH agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, or radiation therapy (except palliative radiation to bony metastases) as cancer therapy within 4 weeks prior to initiation of study treatment (exceptions are kinase inhibitors that are approved by the local regulatory authorities, which may be used within 2 weeks prior to initiation of study treatment, provided that any drug-related toxicity has completely resolved and after approval by the Medical Monitor has been granted)
- Palliative radiation to bony metastases within 2 weeks prior to initiation of study treatment
- Need for chronic corticosteroid therapy
- Treatment with an investigational agent within 4 weeks prior to initiation of study treatment
- Unresolved toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy
- Pregnancy or lactation
- Inability to comply with study and follow-up procedures
- For patients eligible to participate in Stage 2 DCE-MRI and MRS assessments, any contraindication to MRI examination, including the following:
- Imbedded metallic material/devices (metal implants or large tattoos in the field of view)
- Severe claustrophobia
- Physical characteristics (weight or size) that exceed the capabilities of the MRI scanner
- Known allergy or hypersensitivity reactions to gadolinium, verse
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00876122
Start Date
March 1 2008
End Date
July 1 2012
Last Update
November 2 2016
Active Locations (1)
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1
Sutton, United Kingdom, SM2 5PT