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View Clinical Trial (Medical Research Study)
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A Phase 1 Dose-Escalation Study in Advanced Solid Tumors, Lymphomas or Multiple Myeloma (Study P05538AM2) - NCT00725634-78229 (Clinical Trial 234289)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy234289.aspx
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| City: |
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San Antonio |
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State:
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TX |
| Zip Code: |
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78229 |
| Conditions: |
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Neoplasms - Lymphoma - Multiple Myeloma |
| Purpose: |
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The primary objective of this study is to determine safety, tolerability, dose-limiting
toxicities and recommended dose of SCH 900105 administered intravenously (IV) to subjects
with relapsed or refractory solid tumors, lymphoma or multiple myeloma.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
For Advanced Solid Tumors or Lymphoma:
- Diagnosis of advanced solid tumor malignancy or lymphoma (Hodgkin's or
non-Hodgkin's).
- Histological or cytological evidence of malignancy.
- Advanced malignancy, metastatic or unresectable, that has recurred or progressed
after standard therapy (ST) or failed ST, or for which no ST currently exists.
- If ST exists, the subject is unwilling to receive it or is not a candidate for it.
- Disease currently not amenable to curative surgery.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. Subjects
with ECOG PS of 2 will be considered only after discussion between the investigator
and the medical monitor.
- Age >=18 years, either sex, and any race.
- Adequate hematologic, hepatic, renal, and coagulation function with:
- Hemoglobin >=9 g/dL,
- White blood cell count >=3000/mm^3,
- Absolute neutrophil count (ANC) >=1500/mm^3,
- Platelet count >=100,000/mm^3,
- Serum bilirubin <=1.5 x upper limit of normal (ULN),
- For subjects in the dose escalation cohorts: serum AST/ALT <=3 × ULN for the
reference laboratory,
- For subjects in the RP2D safety expansion cohorts:
- without known hepatic metastasis: serum AST/ALT <=3 × ULN for the reference
laboratory,
- with known hepatic metastasis: serum AST/ALT <=5 × ULN,
- Serum creatinine <=1.5 x ULN or calculated creatinine clearance >60 mL/min,
- Prothrombin time (PTT) <=1.5 x ULN and international normalized ratio (INR)
>=1.5 x ULN.
- Subjects with abnormal liver function tests (LFTs) must be screened for Hepatitis B
and C (unless screened within 6 months prior to study enrollment) and can only be
enrolled if screening is negative.
For the Multiple Myeloma Exploratory Cohort:
- Diagnosis of symptomatic relapsed or refractory multiple myeloma.
- Measurable disease assessed by one of the following:
- Serum monoclonal protein >=1.0 g/dL by protein electrophoresis;
- >200 mg of monoclonal protein in the urine on 24 hour electrophoresis;
- Serum immunoglobulin free light chain >=10 mg/dL AND abnormal serum
immunoglobulin kappa to lambda free light chain ratio, or
- Monoclonal bone marrow plasmacytosis >=30% (evaluable disease).
- At least 2 prior therapies and no more than 4 prior therapies (no more than 3 if stem
cell/bone marrow transplant was involved
- ECOG PS of 0, 1 or 2.
- Age >=18 years, either sex, and any race.
- Adequate hematologic, hepatic, renal, and coagulation function with:
- Hemoglobin >=9 g/dL,
- ANC >=1000/mm^3,
- Platelet count >=50,00/mm^3 (Screening platelet count must be independent of
platelet transfusions for >=2 weeks),
- Serum bilirubin <=1.5 x ULN,
- Serum AST and ALT <=3 x ULN,
- Serum creatinine <=3.0 mg/dL,
- PTT <=1.5 x ULN and INR <=1.5 x ULN.
- All previous cancer chemotherapy, including radiation, hormonal therapy, and surgery,
must have been discontinued >=2 weeks prior to first dose of study drug.
- Subjects with abnormal LFTs must be screened for Hepatitis B and C (unless screened
within 6 months prior to study enrollment) and can only be enrolled if screening is
negative.
Exclusion Criteria:
For Advanced Solid Tumors or Lymphoma:
- Primary central nervous system (CNS) malignancy or symptomatic CNS metastases, or
leptomeningeal metastases. However, subjects with glioblastoma multiforme may be
enrolled in the RP2D Safety Expansion Cohort. Subjects with treated brain metastases
that have remained stable for at least 3 months without steroids are allowed.
Subjects with spinal cord or nerve root compression who have completed treatment at
least 4 weeks prior to the first dose of study drug and are stable without steroid
treatment for at least 1 week prior to the first dose of study drug are allowed.
- Hematologic malignancies other than lymphoma.
- Radiotherapy within 3 weeks prior to first dose of study drug.
- Subjects who have received anti-c-Met agents, AMG-102 or any other anti-HGF therapy.
- Stem cell/bone marrow transplant within 6 months of first dose of study drug.
For the Multiple Myeloma Exploratory Cohort:
- Active malignancy of any kind requiring or likely to require treatment within the
next 12 months, except basal cell skin cancer, in situ cervical cancer, in situ
breast cancer, and asymptomatic prostate cancer.
- Any of the following prior to first dose of study drug: POEMS
(polyneuropathy,organomegaly, endocrinopathy, monoclonal protein, and skin changes),
plasma cell leukemia, or Waldenstrom's macroglobulinemia.
- Radiotherapy within 3 weeks prior to first dose of study drug, except when used as a
palliative for pain.
- Maintenance steroid therapies of >20 mg/day prednisone, >4 mg/day dexamethasone, >80
mg/day hydrocortisone, or equivalent
- Prior therapy involving anti-HGF antibody or c-Met small molecule inhibitor.
- Allogeneic stem cell/bone marrow transplant within 12 months of first dose of study
drug.
For All Subjects:
- Any of the following within 6 months prior to first dose of study drug: myocardial
infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft,
symptomatic congestive heart failure, cerebrovascular accident, transient ischemic
attack or seizure disorder.
- Serious and/or symptomatic active infection within 14 days prior to first dose of
study drug. Subjects with asymptomatic or mild infection who are taking a short
course of antibiotics may be allowed after discussion with the medical monitor.
- Baseline QTc interval as per Bazett's formula: females >470 msec, males >450 msec.
- Persistent, unresolved Grade 2 or higher drug-related toxicity (except alopecia,
erectile dysfunction, hot flashes, and decreased libido) associated with previous
treatment.
- Inadequate recovery from any prior surgical procedure, or major surgical procedure
performed within 4 weeks prior to first dose of study drug, or major surgery within 3
weeks prior to first dose of study drug.
- Known human immunodeficiency virus (HIV) infection, or known HIV-related malignancy.
- Known active hepatitis B or C.
- Active alcohol abuse.
- Subject who has received any medication prohibited in this study more recently than
the required washout period prior to first dose of study drug. |
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| Study is available at: |
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Investigational Site 1
San Antonio, TX 78229
United States
Primary Contact:
SP Clinical Trial Registry Call Center
Phone: 1-888-772-8734 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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