A pilot study of safety and adequacy of pancreatic lesion biopsy (Spy Bite)
The purpose of this study is to determine the safety and effectiveness of an experimental technique to obtain biopsies of pancreatic lesions. This technique uses biopsy forceps, which are small jaw-like devices that open and close, to also obtain tissue samples for examination and diagnosis. The biopsy forceps will pass through the endoscope that is already in place for the endoscopic ultrasound guided fine needle aspiration procedure, and an additional biopsy will be taken. This technique is experimental because biopsy forceps are routinely used in gastrointestinal endoscopy, but are not routinely used to obtain biopsies of the pancreas.
A pilot study of safety and efficacy of spectroscopic diagnosis of pancreatic lesions (Spy Panc)
The objective of this study is to determine if a minimally invasive optical probe can accurately predict a histological diagnosis of dysplastic or malignant tumor cells in solid lesions of the pancreas. If effective, this optical probe would facilitate the detection of malignant and pre-malignant pancreatic lesions. This would lead to more accurate decision-making as to which patients require surgical resection versus patients who should be spared from major surgery.
0C-14-7: A Phase 1/2A, Multicenter, Open-Label Study of Oral RxDx-101 in Adult Patients with Locally Advanced or Metastatic Cancer Confirmed to be Positive for TRKA, TRKB, TRKC, ROS1, or ALK Molecular Alterations
RXDX-101-01 is a multicenter, open-label, Phase 1/2a study in which the safety and efficacy of RXDX-101 will be evaluated in adult patients with any locally advanced or metastatic solid tumor.
The primary objective of the Phase 2a expansion cohorts is Objective Response (OR) defined as Complete Response(CR) and Partial Response (PR) at the recommended phase 2 dose of RXDX-101.
RXDX-101 is an orally available inhibitor of the tyrosine kinases TrkA, TrkB, TrkC, ROS1, and ALK. Molecular alterations to these targets are present in several different tumor types, including non-small cell lung cancer, colorectal cancer, papillary thyroid cancer, pancreatic cancer, and neuroblastoma.
The Phase 2a segment of this study will consist of 5 cohorts as described below:
Cohort #1: Participants that express TrkA. Cohort #2: Participants that express TrkB. Cohort #3: Participants that express TrkC. Cohort #4a: Participants that express ALK with an associated molecular alteration who are nave to prior treatment with ALK inhibitors. Cohort #4b: Participants that express ALK with an associated molecular alteration who have received prior treatment with one or more ALK inhibitors. Cohort #5: Participants that express ROS1
USC will only participate in Phase 2 of the study. The length of participation is about 2 months
An End of Treatment Visit will be conducted within 7 days of last dose of RXDX-101.
A Safety Follow-Up telephone call will be conducted approximately 30 days following the last dose of RXDX-101.
Primary endpoint will be first cycle dose limiting toxicities and maximum tolerated dose
The baseline, clinical outcome, laboratory, PK, and safety data from both segments of the study will be analyzed descriptively
Spectroscopic detection of colon polyps (Spy Colonic Neoplasia)
The purpose of this study is to determine if colon cancer or precancerous colon polyps can be predicted from examining the lining of the rectum with a special harmless light. If so, primary care physicians will be able to determine from this simple test which of their patients actually needs a colonoscopy instead of referring 100% of their patients simply because they turn 50 years old.
A Pilot Multi-arm Study of sEphB4-HSA in Combination With Different Chemotherapy Regimens in Patients With Specific Advanced or Metastatic Solid Tumors
I. To document the safety and tolerability of sEphB4-HSA (recombinant ephB4-HSA fusion
protein) intravenously (IV) weekly when administered in combination with: arm A) gemcitabine
(gemcitabine hydrochloride) and nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle
formulation), arm B) docetaxel, arm C) gemcitabine and cisplatin.
I. To describe the adverse event profile of sEphB4-HSA IV weekly when administered in
combination with: arm A) gemcitabine and nab-paclitaxel, arm B) docetaxel, arm C) gemcitabine
II. To characterize the pharmacokinetics of sEphB4-HSA when combined with: arm A) gemcitabine
and nab-paclitaxel, arm B) docetaxel, arm C) gemcitabine and cisplatin.
III. To assess, in a preliminary fashion, the anti-tumor efficacy of sEphB4-HSA in
combination with the various chemotherapy regimens in each of the 4 cohorts separately: Arm A
cohort 1-patients with advanced pancreatic cancer; Arm B cohort 2-patients with head and neck
cancer; Arm B cohort 3-patients with non-small cell lung cancer; Arm C cohort 3: patients
I. To evaluate the expression of EPH receptor B4 (EphB4) and ephrinB2 in the archival tumor
samples and explore potential associations with outcome.
II. To bank specimens for future correlative biomarkers studies based on the results of
ongoing biomarkers analyses in the phase I of sEphB4-HSA as a single agent.
OUTLINE: This is a dose de-escalation study of recombinant EphB4-HSA fusion protein. Patients
are assigned to 1 of 3 treatment arms.
ARM A: Patients receive recombinant EphB4-HSA fusion protein IV over 1 hour on days 1, 8, 15,
and 22 (beginning course 2), paclitaxel albumin-stabilized nanoparticle formulation IV over
30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive recombinant EphB4-HSA fusion protein IV over 1 hour on days 1, 8, and
15 (beginning course 2) and docetaxel IV over 1 hour on day 1. Courses repeat every 21 days
in the absence of disease progression or unacceptable toxicity.
ARM C: Patients receive recombinant EphB4-HSA fusion protein IV over 1 hour on days 1, 8, and
15 (beginning course 2), cisplatin IV over 120 minutes and gemcitabine hydrochloride IV over
30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.
In all arms, patients with chemotherapy related toxicity may continue treatment with
recombinant EphB4-HSA fusion protein alone. Patients with toxicity related to recombinant
EphB4-HSA fusion protein may continue treatment with chemotherapy at the discretion of the
After completion of study treatment, patients are followed up periodically.
A Phase Ib Study of Guadecitabine (SGI-110) and Durvalumab (MEDI 4736) in Patients With Advanced Hepatocellular Carcinoma, Pancreatic Adenocarcinoma, and Cholangiocarcinoma/Gallbladder Cancer
I. To evaluate the dose limiting toxicities and determine the maximum tolerated
dose/recommended phase 2 dose of the combination of guadecitabine and durvalumab. (Dose
escalation part) II. To evaluate the objective response rate (per Response Evaluation
Criteria in Solid Tumors [RECIST] 1.1) for the combination of guadecitabine and durvalumab in
hepatocellular carcinoma, pancreatic cancer and cholangiocarcinoma cohorts, respectively.
I. To describe the safety and tolerability of the combination of guadecitabine and
II. To estimate the progression-free and overall survival of patients with advanced
hepatocellular carcinoma (HCC), pancreatic cancer and biliary cancers treated with the
combination of guadecitabine and durvalumab.
I. Correlate programmed cell death ligand 1 (PD-L1) and programmed cell death protein 1 (PD1)
expression on various cells within tumor samples and anti-tumor effect (response rate and
II. Correlate effector T cells (Teff)/regulatory T cells (Treg) ratio in the tumor and
III. Correlate granulocytic and monocytic myeloid-derived suppressor cells (MDSCs) level in
the peripheral blood using fluorescence-activated cell sorting (FACS) and anti-tumor effect.
IV. Evaluate changes in inflammatory T cell signatures pre and post treatment and potential
associations with anti-tumor effect.
V. Assess the induction, activation, expansion and tumor infiltration of tumor
neo-epitope-specific T cells.
VI. Explore changes in gene methylation and expression with anti-tumor effect, with
particular emphasis on the ancestry-informative marker (AIM) gene panel.
VII. Correlate immunologic changes in pre- and post-treatment peripheral blood mononuclear
cell (PBMCs) and anti-tumor effect.
OUTLINE: This is a dose-escalation study of guadecitabine.
Patients receive guadecitabine subcutaneously (SC) once daily (QD) on days 1-5 and durvalumab
intravenously (IV) over 60 minutes on day 8. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 2 months.