Phase 1 Study of Anti-HB-EGF Monoclonal Antibody KHK2866 as Monotherapy in Subjects With Advanced Solid Tumors and in Combination With Chemotherapy in Ovarian Cancer
During Phase 1a, groups of eligible patients with advanced solid tumors will receive KHK2866
as monotherapy in escalating doses. The Phase 1b portion will enroll patients with ovarian
cancer who will receive KHK2866 in combination with one of three chemotherapy regimens
(Arms): gemcitabine+carboplatin (platinum-sensitive, weekly paclitaxel (platinum-resistant),
or pegylated liposomal doxorubicin (platinum-resistant). Escalating doses of the combination
of KHK2866 and the chemotherapy regimen will given to two groups of subjects per Arm. The
goal of the study is to learn about the side effects of KHK2866 alone or given in combination
with chemotherapy. All subjects will receive study therapy for up to 6 cycles (up to 12
cycles for subjects assigned to PLD [Arm 3 of Phase 1b]), or until disease progression, the
development of severe side effects, noncompliance or withdrawal of consent by the subject, or
other removal criteria whichever comes first.
A Phase II, Randomized, Multicenter Study of CDX-011 (CR011-vcMMAE) in Patients With Advanced GPNMB-expressing Breast Cancer
CDX-011 consists of an antibody attached to a drug, monomethyl auristatin E (MMAE), that can
kill cancer cells. The antibody delivers the drug to cancer cells by attaching to a protein
called glycoprotein NMB (GPNMB) that is expressed on the cancer cell. The MMAE is then
released inside of the cell, where it interferes with cell growth and may lead to cell death.
This study will examine the effectiveness and safety of CDX-011 in patients with advanced
breast cancer that makes the GPNMB protein. To better assess this, the effect of CDX-011 will
be compared to treatment with currently available cancer chemotherapy.
Eligible patients who enroll in the study will be randomly assigned by chance to receive
treatment with CDX-011 or with a chemotherapy chosen by their study doctor from a list of
currently available drugs ("Investigator's Choice" chemotherapy). For each three patients
enrolled, two will receive CDX-011 and one will receive treatment with "Investigator's
Choice". Patients initially assigned to "Investigator's Choice" chemotherapy may be offered
treatment with CDX-011 if their cancer worsens during this initial treatment.
All patients enrolled in the study will be closely monitored to determine if their cancer is
responding to treatment, and for any side effects that may occur.
Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea
This study is designed to evaluate the role of drug-induced sleep endoscopy (DISE) in patients undergoing obstructive sleep apnea surgery at Keck Medical Center of USC. Our previous research has determined the reliability of DISE and compared DISE to other evaluation techniques. Our ongoing research examines how DISE can be used to improve outcomes in sleep apnea surgery.
S1313, A Phase IB/II Randomized Study of Modified FOLFIRINOX + Pegylated Recombinant Human Hyaluronidase (PEGPH20) Versus Modified FOLFIRINOX Alone in Patients With Good Performance Status Metastatic Pancreatic Adenocarcinoma
PRIMARY OBJECTIVES:
I. To assess the safety of modified leucovorin calcium, fluorouracil, irinotecan
hydrochloride and oxaliplatin (mFOLFIRINOX) in combination with PEGPH20 and select the
optimal dose of PEGPH20 for the phase II portion in patients with metastatic pancreatic
adenocarcinoma. (Phase I) II. To assess the overall survival of patients with metastatic
pancreatic adenocarcinoma treated with mFOLFIRINOX + PEGPH20 compared to those treated with
mFOLFIRINOX alone. (Phase II)
SECONDARY OBJECTIVES:
I. To assess progression free survival (PFS) in patients receiving mFOLFIRINOX with PEGPH20
and patients receiving mFOLFIRINOX alone in this patient population.
II. To assess objective tumor response (confirmed and unconfirmed, complete and partial) in
patients with measurable disease treated with mFOLFIRINOX with PEGPH20 and patients receiving
mFOLFIRINOX alone in this patient population.
III. To determine the frequency, severity, and tolerability of adverse events of mFOLFIRINOX
with PEGPH20.
TERTIARY OBJECTIVES:
I. To explore the correlation of maximum decrease in cancer antigen (CA) 19-9 levels and time
to maximum decrease in CA 19-9 levels with overall survival, progression-free survival and
response.
II. To explore the correlation of plasma hyaluronan (HA) and tumor expression of HA with
overall survival, progression-free survival and response.
OUTLINE: This is a phase I, dose de-escalation study of pegylated recombinant human
hyaluronidase followed by a randomized phase II study.
PHASE I: Patients receive pegylated recombinant human hyaluronidase intravenously (IV) over
10 minutes on day 1*; oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and
irinotecan hydrochloride IV over 1.5 hours on day 2; and fluorouracil IV over 46 hours on
days 2-4. Courses repeat every 14 days in the absence of disease progression or unacceptable
toxicity.
PHASE II: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and
irinotecan hydrochloride IV over 1.5 hours on day 2, and fluorouracil IV over 46 hours on
days 2-4. Courses repeat every 14 days in the absence of disease progression or unacceptable
toxicity.
ARM II: Patients receive pegylated recombinant human hyaluronidase IV over 10 minutes on day
1* and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and fluorouracil as in Arm
I. Courses repeat every 14 days in the absence of disease progression or unacceptable
toxicity.
*NOTE: Some patients also receive pegylated recombinant human hyaluronidase on day 3 or 4 of
courses 1 and 2.
After completion of study treatment, patients are followed up for 3 years.
Evaluation of Safety, Pharmacokinetics and Immunomodulatory Effects of AB103, a CD28 Co-stimulatory Receptor Antagonist, in Patients Diagnosed With Necrotizing Soft Tissue Infections
A study to evaluate the safety and pharmacokinetics profile of different doses of AB103
administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled
for an urgent surgical intervention as part of their standard of care. The primary study
hypothesis is that AB-103 can be administered safely to the patients presenting with
Necrotizing Soft Tissue Infections.
Secondary endpoints are efficacy by exploratory descriptive analyses of specific efficacy
endpoints from three outcome domains to demonstrate treatment benefit of AB103 in comparison
to placebo in patients with Necrotizing Soft Tissue Infections. The efficacy domains are:
1. Clinical status domain
2. Pharmacoeconomics domain
3. Systemic and local inflammatory biomarker domain
0C-12-1-A Phase 1 Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics and Safety of Crizotinib in Advanced Cancer Patients [A8081012]
This is a research study for advanced cancer with varying degree of liver function (normal, mild impairment, moderate impairment or severe impairment). The main purposes of this research study are to see whether a newly approved drug, crizotinib (Xalkori), can be used in patients with liver function that is not normal and to see whether crizotinib can prevent or slow down your cancer from growing, and to assess any side effects that you may have. Some other purposes of this study are to measure how much crizotinib is in your blood, and to provide dosing recommendations for patients with impaired liver function. Crizotinib is approved in the United States (US) and is available by prescription for non-small cell lung cancer (NSCLC) patients with Anaplastic Lymphoma Kinase (ALK) mutation. However, the use of crizotinib in this study is experimental. Crizotinib is not currently approved to treat other advanced cancer patients with unclear ALK status and/or with liver function that is not normal. . The participants of this study will be in this study until their disease progresses (gets worse), they experience unacceptable side effects or they withdraw consent. There will be about 50 advanced cancer patients enrolled in this study. The study is being done at about 3-5 different research sites in US. About 45 participants will take part at USC. This is a multicenter, open-label, non-randomized, phase 1 study. The endpoints are how the drug behaves in the body when taken (pK), effectiveness and safety of the study drug. There will be 5 groups (Groups A1, A2, B, C and D) involved in this study. Groups A1 and A2 have normal liver functions. Group A1 will match Group B(mild) and Group A2 will match Group C(moderate).The study drug is given by mouth and should be taken at approximately the same time each day on a continuous daily dosing.One-way analysis of variance (ANOVA) will be used for statistical analysis. Individual concentration of the study drug in the blood will be listed and summarized. The safety analysis population will include all enrolled patients who receive at least one does of crizotinib. The safety analysis population will be the primary population for evaluating patient characteristics, treatment administration and safety. Safety data will be reviewed on an ongoing basis during the study.
Not recruiting | Any Cancer Condition or Solid Tumor | Multisite
Long-Term Registry of Patients with Urea Cycle Disorders (UCDs)
The main goal of medical management of Urea Cycle Disorder (UCD) patients is to prevent chronic or acute hypperammonemic states leading to central nervous damage- which requires a restriction in dietary protein intake and using nitrogen scavenging agents if diet alone does not help the patients.The objective of this study is to characterize the demographic of the patient population diagnosed with UCD. Another objective is to track growth and neuro-cognitive outcomes for patients with UCDs. Patient participation includes the collection of retrospective and baseline data including ammonia and glutamine levels. Age appropriate questionaires will be given for completion by subject or parent. . Data will be collected on all individuals who are enrolled. The patient population are patients with an established or suspected diagnosis of UCD. The patient or legally acceptable representative must also sign and release an informed consent/HIPPA Authorization and medical records.The study procedures are for each study personnel to be trained for all documentation, baseline visits and enrollment for patients, and retrospective data for ammonia values obtained from the patient will be entered in the registry. The outcome variables will be the control of blood ammonia levels and the frequency of the serious adverse events (SAEs). Blood ammonium levels, and the frequency of hyperammonemic crisis will be observed during this study.The statistical analysis plan (SAP) will show details of all analysis and presentation of study data. Data will be shown to patients who attend the baseline visit, and analysis will be based on all the patients who are enrolled. Post baseline values or change from the baseline outcome variables will be summarized by UCD medication with statistics and graphical presentations.
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