NL-OMON39586
Completed
Not Applicable
A Phase 1b Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GS-9820 Monotherapy and Combination Therapy in Subjects with Lymphoid Malignancies - Study evaluating GS-9820 with patients with lymphoid malignancies.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- on-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, indolent Hodgkin's Lymphoma
- Sponsor
- Gilead Sciences
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Male or female \*18 years of age.
- •2\) Diagnosis of B\-cell iNHL, DLBCL, MCL, HL, or CLL as documented by medical records and with histology based on criteria established by the World Health Organization.
- •3\) Prior treatment for lymphoid malignancy.
- •4\) Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of \*1 lesion that measures \*2\.0 cm in the longest dimension \[LD] and \*1\.0 cm in the longest perpendicular dimension \[LPD] as assessed
- •by CT or MRI).
- •5\) Discontinuation of all therapy (including radiotherapy, chemotherapy, immunotherapy, systemic corticosteroids, or investigational therapy) for the treatment of cancer \*3 weeks before
- •the start of study therapy.
- •6\) All acute toxic effects of any prior antitumor therapy resolved to Grade \*1 before the start of study therapy (with the exception of alopecia \[Grade 1 or 2 permitted], neurotoxicity \[Grade 1 or 2
- •permitted], or bone marrow parameters \[any of Grade 1, 2, or 3 permitted).
- •7\) Karnofsky performance score of \*60\.
Exclusion Criteria
- •1\) Known histological transformation to an aggressive form of NHL (ie, Richter transformation).
- •2\) Known active central nervous system or leptomeningeal lymphoma.
- •3\) Presence of intermediate\- or high\-grade myelodysplastic syndrome (ie, subjects are excluded who have \*5 bone marrow blasts; karotypic abnormalities other than normal, Y deletion, 5q deletion, or 20q deletion; or \*2 lineages of cytopenias).
- •4\) History of a non\-lymphoid malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer,
- •asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate\-specific antigen for \*1 year prior to start of study therapy, other adequately treated Stage 1 or 2 cancer currently
- •in complete remission, or any other cancer that has been in complete remission for \*5 years.
- •5\) Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of start of study therapy (Visit 2\).
- •6\) Ongoing liver injury, chronic active HCV, HBV, alcoholic liver disease, non\-alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
- •7\) Ongoing drug\-induced pneumonitis.
- •8\) Ongoing inflammatory bowel disease.
Outcomes
Primary Outcomes
Not specified
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