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View Clinical Trial (Medical Research Study)
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A Phase 1 Dose-escalation Study of a Cell Cycle Inhibitor With and Without Gemcitabine in Patients With Solid Tumors or Lymphoma (Study P05248AM2) - NCT00779584-33612 (Clinical Trial 326962)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy326962.aspx
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| City: |
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Tampa |
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State:
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FL |
| Zip Code: |
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33612 |
| Conditions: |
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Hodgkin Disease - Lymphoma, Non-Hodgkin - Neoplasms |
| Purpose: |
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This first study in humans of SCH 900776 will evaluate its safety and tolerability when
given as monotherapy or in combination with gemcitabine to patients with advanced solid
tumors or lymphoma. Subjects will be enrolled in cohorts that will receive sequentially
higher doses of SCH 900776 in combination with standard doses of gemcitabine The recommended
combination doses for a Phase 2 trial (RP2D) will be determined based on safety and
biological activity. Up to 10 to 15 additional subjects will be studied at the
combination-RP2D.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Must have a diagnosis of an advanced solid tumor malignancy or lymphoma
(non-Hodgkin's or Hodgkin's lymphoma).
- Must have histological or cytological evidence of malignancy.
- Subjects must have an advanced malignancy, metastatic or unresectable. For Part A of
the study, the metastatic or unresectable malignancy should have recurred or
progressed following standard therapy or failed standard therapy; or for which no
standard therapy currently exists, or for which they are not candidates for standard
therapy. For Parts B and C of the study, subjects with advanced tumors for which
gemcitabine is considered standard therapy (eg, pancreatic cancer), may be enrolled
without having received prior gemcitabine. Standard therapy is defined as therapy
that is approved in a particular line of therapy or considered as standard of care
based on published peer reviewed data in a specific line of therapy.
- Gemcitabine-naïve subjects with tumors known to be responsive to gemcitabine or
subjects previously treated with gemcitabine who did not progress while on treatment
or who are currently still responding to treatment should only be enrolled in
cohorts for which gemcitabine doses are >=1000 mg/m². Subjects previously treated
with gemcitabine, whose disease has progressed wile on treatment, can be enrolled to
any part.
- Must be ambulatory with an Eastern Cooperative Oncology Group (ECOG) performance
status of 0 or 1.
- Must be 18 years or older, of either sex, and of any race.
- Subjects (and/or parent/guardian for subjects who otherwise are unable to provide
independent consent) must be willing to give written informed consent and able to
adhere to dose and visit schedules.
- Female subjects of childbearing potential must have a negative pregnancy test within
7 days of first dose of protocol therapy.
- Female subjects of childbearing potential and male subjects whose sexual partners are
of childbearing potential must agree to abstain from sexual intercourse or to use an
acceptable method of contraception during the study and for 90 days following the
last dose of protocol therapy. Acceptable methods of contraception include condoms
(male or female) with or without spermicidal agent, diaphragm or cervical cap with
spermicide, medically prescribed intrauterine device (IUD), oral or injectable
hormonal contraceptive, and surgical sterilization (eg, hysterectomy or tubal
ligation).
- Must have adequate bone marrow reserve as evidenced by a white blood cell (WBC) count
>=3,000/ μL, absolute neutrophil count (ANC) >=1,500/μL AND platelet count
>=100,000/μL.
- Must have adequate renal function as evidenced by a serum creatinine level <=1.5 x
upper limit of normal (ULN) or a calculated creatinine clearance >60 mL/min.
- Subjects, except those with known Gilbert's Syndrome, must have adequate hepatic
function as evidenced by a serum bilirubin level <=1.5 x the ULN AND serum levels of
aspartate and alanine aminotransferase (AST/ALT) levels <=3 x the ULN for the
reference lab (subjects with known hepatic metastases must have serum AST/ALT levels
<=5 x the ULN for the reference lab).
- Must be recovered from the effects of any prior surgery, radiotherapy or systemic
antineoplastic therapy.
Exclusion Criteria:
- Has a known hypersensitivity to SCH 900776 or gemcitabine or to any of their
excipients or has received therapy with another CHK1 inhibitor.
- Has received any prohibited medication listed below more recently than the indicated
washout period prior to first dose of protocol therapy or must continue to receive
prohibited medications, cytochrome P450 1A2 strong inhibitors or inducers, P-gp
inhibitors or inducers, any chemotherapy, or investigational drugs.
- Has significant underlying cardiac conduction system abnormalities such as
bifascicular or greater block (eg, right bundle branch block with left anterior
hemiblock or first degree atrioventricular block), fixed-rate pacemaker, or chronic
atrial fibrillation with variable ventricular rate.
- Has persistent, unresolved Common Terminology Criteria for Adverse Events (CTCAE) v
3.0 >=Grade 2 drug-related toxicity (except alopecia, erectile impotence, hot
flashes, and decreased libido) associated with previous treatment.
- Has known human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or a known
history of liver cirrhosis or active alcohol abuse.
- Is New York Heart Association (NYHA) Class III.
- Has any other medical or psychiatric condition that, in the opinion of the
investigator, might interfere with the subject's participation in the trial or
interfere with the interpretation of trial results.
- Has undergone major surgery within 3 weeks prior to first study drug administration
after enrollment.
- Has central nervous system (CNS) or leptomeningeal metastases.
- Has received radiation therapy within 3 weeks prior to first study drug
administration after enrollment or radiation therapy to >25% of bone marrow.
- Has received more than three prior chemotherapy regimens (subjects may have received
prior gemcitabine if they did not experience >CTCAE v 3.0 Grade 1 myelotoxicity and
after discussion with the sponsor). Subjects with more than three prior chemotherapy
regimens, one or more of which were targeted, nonmyelosuppressive agents, may be
considered on a case-by-case basis after discussion with the sponsor.
- Has undergone previous allogeneic or autologous stem cell transplant.
- Has had any of the following within 6 months prior to first study drug administration
after enrollment: myocardial infarction, severe/unstable angina pectoris,
coronary/peripheral artery bypass graft, symptomatic congestive heart failure,
cerebrovascular accident or transient ischemic attack, or seizure disorder.
- Has a known bleeding diathesis, eg, hemophilia.
- Has a baseline QTc interval >470 msec (ie, CTCAE v 3.0 Grade >=2).
- Currently a smoker and/or is likely to smoke during the study.
- Female subject is breast-feeding, pregnant, or intends to become pregnant.
- Participating in any other interventional clinical study. (Subject participating in
another noninterventional study may be considered after discussion with the sponsor.)
- Part of the staff personnel directly related to this study.
- Family member of one of the investigational staff. |
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| Study is available at: |
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Investigational Site 3
Tampa, FL 33612
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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