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Study Title Principal Investigator
0S-14-3: Phase II Study of Single Agent Regorafenib in Patients with Advanced/Metastatic Neuroendocrine Tumors
The primary objective of this study is to assess Progression free survival in advanced/metastatic patients with carcinoid or pancreatic islet cell tumorsNeuroendocrine tumors, which include carcinoid tumors and pancreatic islet cell tumors, are rare malignancies. Regorafenib is a multiple kinase inhibitor targeting several receptor tyrosine kinases that are involved in tumor progression. In addition, regorafenib blocks VEGF dependent kinase activation. Hence, Regorafenib is being studied as a potential treatment of neuroendocrine tumors as a single agent.Regorafenib 160 mg qd will be administered for 3 weeks on /1 week off. Participants may remain on study until the development of disease, development of intolerable toxicity, or any of the criteria for removal of the study as set forth in the protocol.The 6-month progression free survival rate will be the primary endpoint. Two parallel Simons 2-stage phase II trials will be conducted to evaluate the efficacy of regorafenib.
Not yet recruiting | Neuroendocrine Tumors | Multisite
Syma Iqbal
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0S-15-5 A Pilot Multi-Arm Study of sEphB4-HSA In Combination with Different Chemotherapy Regimens in Patients with Specific Advanced or Metastatic Solid Tumors
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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 and cisplatin. 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 with cholangiocarcinoma. TERTIARY OBJECTIVES: 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 investigator. After completion of study treatment, patients are followed up periodically.
Recruiting | Lung Cancer | Multisite
Anthony El-Khoueiry
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SWOG-S1115: Randomized Phase II Clinical Trial of AZD6244 Hydrogen Sulfate (NSC-748727) and MK-2206 (NSC-749607) vs MFolfox in Patients with Metastatic Pancreatic Cancer After Prior Chemotherapy
PRIMARY OBJECTIVES: I. To assess overall survival in patients with metastatic pancreatic cancer treated with the combination of AZD6244 hydrogen sulfate (selumetinib) and MK-2206 (Akt inhibitor MK2206) compared to those treated with mFOLFOX. SECONDARY OBJECTIVES: I. To assess the frequency and severity of toxicity associated with the combination of AZD6244 hydrogen sulfate and MK-2206 compared to those with mFOLFOX in this patient population. TERTIARY OBJECTIVES: I. To assess progression free survival (PFS) in patients with metastatic pancreatic cancer treated with the combination of AZD6244 hydrogen sulfate and MK-2206 compared to those treated with mFOLFOX. II. To assess objective tumor response in the subset of patients with measurable disease (confirmed and unconfirmed complete and partial response) in patients with metastatic pancreatic cancer treated with the combination of AZD6244 hydrogen sulfate and MK-2206 compared to those treated with mFOLFOX. III. To bank tissue and blood for future translational medicine studies. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive oxaliplatin intravenously (IV) over 2 hours on days 1 and 15 and fluorouracil IV over 46-48 hours on days 1-2 and 15-16 (mFOLFOX). ARM II: Patients receive Akt inhibitor MK2206 orally (PO) on days 1, 8, 15, and 22, and selumetinib PO daily on days 1-28. In all arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 3 years.
Completed | Pancreatic Cancer | Multisite
Syma Iqbal
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3P-14-1: An Open-Label, Phase I Dose Escalation Trial of TH-302 in Combination with Gemcitabine and Nab-Paclitaxel in Previously Untreated Subjects with Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma
Terminated | Pancreatic Cancer | Multisite
Heinz-Josef Lenz
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A Phase II-R and a Phase III Trial Evaluating Both *Erlotinib (PH II-R) and Chemoradiation (PH III) as Adjuvant Treatment For Patients With Resected Head of Pancreas Adenocarcinoma
PRIMARY OBJECTIVES: I. To determine whether the addition of erlotinib (erlotinib hydrochloride) to gemcitabine (gemcitabine hydrochloride) adjuvant chemotherapy shows a signal for improved survival as compared to gemcitabine alone following R0 or R1 resection of head of pancreas adenocarcinoma (including adenocarcinoma of the head, neck, and uncinate process). (Phase II-R) II. To determine whether the use of concurrent fluoropyrimidine and radiotherapy following adjuvant gemcitabine hydrochloride-based chemotherapy further enhances survival for such patients who are without evidence of progressive disease after 5 cycles of gemcitabine based chemotherapy. (Phase III) SECONDARY OBJECTIVES: I. To evaluate disease-free survival of adjuvant chemotherapy followed by radiotherapy and concurrent fluoropyrimidine for patients with resected head of pancreas adenocarcinoma who are disease free after 5 cycles of adjuvant chemotherapy. II. To evaluate disease-free survival of standard adjuvant gemcitabine chemotherapy with and without erlotinib for patients with resected head of pancreas adenocarcinoma. III. To evaluate adverse events with and without erlotinib for patients with resected head of pancreas adenocarcinoma. IV. To evaluate adverse events of adjuvant chemotherapy with or without radiation therapy and concurrent fluoropyrimidine for patients with resected head of pancreas adenocarcinoma who are disease free after adjuvant chemotherapy. V. To evaluate preoperative cross-sectional imaging of the primary head of pancreas adenocarcinoma in order to determine the frequency with which objective criteria of resectability are present. VI. To determine if patients reporting low baseline fatigue, as measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, predicts survival and to explore correlations between baseline fatigue, as measured by Patient-Reported Outcomes Measurement Information System (PROMIS), and survival. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive gemcitabine hydrochloride as in arm I and erlotinib hydrochloride orally (PO) once daily on days 1-28. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. (NOTE: Phase II-R erlotinib hydrochloride randomization completed, Arm 2 closed to accrual effective 2/19/2014) Patients with no disease progression after treatment in arm I or II are then stratified according to their first randomization treatment arm (arm I vs arm II) and randomized to 1 of 2 additional treatment arms (arm III or IV). ARM III: Patients receive 1 course of the same treatment that they receive in arm I or II. ARM IV: Patients receive 1 course of the same treatment that they receive in arm I or II. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity-modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO twice daily (BID) 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. After completion of study treatment, patients are followed up periodically.
Recruiting | Breast Cancer | Multisite
Ross Abrams
SWOG-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.
The outcome of patients with metastatic pancreatic cancer remains very poor. Until recently, gemcitabine was the only agent with reproducible activity and resulting in a median survival of only 5-6 months. Despite attempts to improve the outcome by adding a second agent to gemcitabine, no worthwhile progress has been made thus far. There are grounds for optimism as two new regimens (gemcitabine/nab-paclitaxel and FOLFIRINOX) have emerged as front line options. The study drug, recombinant pegylated human hyaluronidase (PEGPH20) is widely used to enhance subcutaneous dispersion and absorption of various agents. It has shown to inhibit tumor growth, and enhance effects of chemotherapy in mouse models of cancer. Plus, other studies have shown the PEGPH20 can damage the outer layer of a tumor which can let more chemotherapy reach the tumor and possibly increase effectiveness. The study will be conducted in two sequential parts. A participant may be enrolled to either the Phase I Portion or the Phase II Portion. The Phase I portion will be a dose de-escalation clinical trial with two dose levels of PEGPH20. For the Phase II portion of the study (which will be temporarily closed to define the dose of PEGPH20) will have two treatment arms (Arm 1-mFolfirinox and Arm 2-PEGPH20+mFolfirinox). All study participants will be followed until death or 3 years after registration. The primary Phase 1 objective is to assess the safety of mFOLFIRINOX in combination with PEGPH20 and select the optimal dose of PEGPH20 for the Phase II portion in patients with metastatic pancreatic adenocarcinoma. While the Phase II objective is to assess the overall survival of patients with metastatic pancreatic adenocarcinoma treated with mFOLFIRINOX + PEGPH20 compared to those treated with mFOLFIRINOX alone. Assuming a 10% ineligibility rate, 7-20 study participants will be accrued to yield 6-18 eligible participants for the Phase I portion of the trial and 152 participants will be accrued to yield 138 eligible participants for the Phase II portion of the trial. The study will require 2 years of accrual, 1.5 years of follow-up, type 1 error of 10%, and 80% power. For the Phase II trial, study participants will be stratified according to Zubrod Performance Status: 0 vs. 1. The primary analysis of overall survival will be conducted in all eligible patients according to the intent-to-treat principle, using the logrank test. The final analysis will take place upon the observation of approximately 110 deaths. An interim analysis will be performed when one-third of the events (approximately 37 deaths) have been observed.
Active, not recruiting | Pancreatic Cancer | Multisite
Syma Iqbal
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3P-12-1: Phase IbMulticenter, Cohort Dose Escalation Trial to Determine the Safety, Tolerance and Preliminary Antineoplastic Activity of Gemcitabine Administered in Combination with Continuous Intravenous Doses of PRI-724, a CBP/ ß- Catenin Inhibitor, to Patients with Advanced or Metastatic Pancreatic Adenocarcinoma Eligible for Second-Line Therapy After Failing First-Line Therapy with FOLFIRINOX(or FOLFOX)
PRI-724 is a small molecule antagonist that binds to the co-activator CBP thereby specifically inhibiting the subset of Wnt/β-catenin-driven genes that are up-regulated in cancer cells. PRI-724 is being developed as a potential antineoplastic agent. Purpose: To determine the safety, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD) of sequential escalating doses per cohort of PRI-724 administered in combination with gemcitabine to patients with adenocarcinoma of the pancreas that is locally advanced, metastatic, or otherwise inoperable, who are candidates for second-line therapy after failing first-line therapy with FOLFIRINOX (i.e., folinic acid [leucovorin], fluorouracil, irinotecan, oxaliplatin) - PRI-724: 320, 640, 905 mg/m2/day, continuous intravenous (CIV) infusion over 24 h, daily × 7 days, 1 week on with 1 week recovery × 2 (4 weeks equals 1 cycle) - Gemcitabine: 1000 mg/m2 IV over 30 minutes; 3 weeks on with 1 week recovery (4 weeks equals 1 cycle) Patients with documented, measurable or evaluable adenocarcinoma of the pancreas that is locally advanced, metastatic, or otherwise inoperable, who are candidates for second-line therapy after failing first-line therapy with FOLFIRINOX, will be entered into this phase 1b, multicenter, open-label, non-randomized, dose-escalation per cohort study. The trial is designed to evaluate the safety, tolerability, DLT(s), and MTD of escalating doses of PRI-724, a CBP/ β- catenin inhibitor, when administered in combination with a standard dose of gemcitabine. Correlative studies include characterization of the PK profiles of PRI-724 and gemcitabine, evaluation of the utility of potential PD markers of PRI-724 activity, as well as preliminary assessment of the antineoplastic activity of PRI-724 plus gemcitabine in this patient population.
Completed | Pancreatic Cancer | Multisite
Heinz-Josef Lenz
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A Randomized Phase II Study of Temozolomide or Temozolomide and Capecitabine in Patients With Advanced Pancreatic Neuroendocrine Tumors
PRIMARY OBJECTIVES: I. To evaluate progression-free survival (PFS) associated with temozolomide alone or temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors. SECONDARY OBJECTIVES: I. To evaluate response rates (RR) associated with temozolomide alone or temozolomide and capecitabine treatment in patients with advanced pancreatic neuroendocrine tumors. II. To evaluate overall survival (OS) associated with temozolomide alone or temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors. III. To evaluate the toxicity associated with temozolomide alone or temozolomide and capecitabine treatment in patients with advanced pancreatic neuroendocrine tumors. IV. To evaluate the usefulness of methyl guanine methyltransferase (MGMT) status (by immunohistochemistry [IHC] and promoter methylation) for predicting response in pancreatic neuroendocrine tumor patients treated with either temozolomide or temozolomide and capecitabine. V. To bank radiology images for evaluation of quality, reproducibility, and compliance with computed tomography (CT) methodology. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive temozolomide orally (PO) once daily (QD) on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive capecitabine PO twice daily (BID) on days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, and then every 6 months for 3 years.
Active, not recruiting | Neuroendocrine Tumors | Multisite
Pamela Kunz
3P-14-2: A Phase 3, Multicenter, Open-Label, Randomized Study of Nab-Paclitaxel plus Gemcitabine versus Gemcitabine Alone as Adjuvant Therapy in Subjects with Surgically Resected Pancreatic Adenocarcinoma
ABI-007-PANC-003 is a Phase 3, international, multicenter, randomized, open-label, controlled study that will compare the efficacy of nab-paclitaxel in combination with gemcitabine to gemcitabine alone as adjuvant treatment for 6 cycles in patients with surgically resected pancreatic adenocarcinoma.
Active, not recruiting | Pancreatic Cancer | Multisite
Anthony El-Khoueiry
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0C-15-2: STARTRK-2 (Studies of Tumor Alterations Responsive to Targeting Receptor Kinases-2) An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors that Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements
| Brain Cancer | Multisite
Barbara Gitlitz
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0C-16-2 A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5745 as Monotherapy and in Combination with Chemotherapy in Subjects with Advanced Solid Tumors
| Lung Cancer | Multisite
Heinz-Josef Lenz
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3P-13-2: A Phase 1b Dose Escalation Study of Vantictumab (OMP-18R5) in Combination with Nab-Paclitaxel and Gemcitabine in Patients with Previously Untreated Stage IV Pancreatic Cancer
This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with nab-paclitaxel and gemcitabine in patients with previously untreated stage IV Pancreatic Cancer.Up to approximately 34 patients may be enrolled into the study out of which 8 will be enrolled from USC.Vantictumab is a fully human IgG2 monoclonal antibody that binds the FZD1, 2, 5, 7, and 8 receptors and inhibits Wnt signaling to target cancer stem cells.Pancreatic cancer is a rational target for vantictumab because hyperactivity of Wnt signaling has been strongly linked to the development and progression of pancreatic cancer. Vantictumab combined with gemcitabine showed anti-tumor activity superior to that of gemcitabine alone in a panel of patient-derived xenograft models Based on a recent trial showing a positive effect of nab-paclitaxel in combination with gemcitabine, activity of vantictumab in combination with gemcitabine plus nab-paclitaxel will be studied in this trial.Primary objective of this study is to evaluate the safety and tolerability of vantictumab in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer.Vantictumab will be administered IV on Days 1 and 15 of each 28-day cycle. Nab-paclitaxel mg/m2 and gemcitabine will be administered IV on Days 1, 8, and 15 of each cycle. Depending on safety in this study, additional lower or intermediate dose levels may be evaluated.Study period will last approximately 12 to 21 months.The primary efficacy endpoint is objective response, defined as a complete or partial response, on the basis of investigator assessment using RECIST v1.1.
Active, not recruiting | Pancreatic Cancer | Multisite
Heinz-Josef Lenz
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3P-13-3: A Phase 1b Dose Escalation Study of OMP-54F28 in Combination with Nab-Paclitaxel and Gemcitabine in Patients with Previously Untreated Stage IV Pancreatic Cancer
This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of OMP-54F28 when combined with nab-paclitaxel and gemcitabine. OMP-54F28 is a recombinant fusion binds all Wnt proteins tested and thereby antagonizes Wnt-activated signaling. Recent studies showed that Wnt pathway inhibition by OMP-54F28 was highly effective in combination with gemcitabine plus nab-paclitaxel, quite often leading to tumor regression.Primary Objectives of this study are to evaluate the safety and tolerability of OMP-54F28 in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer and to identify dose-limiting toxicities (DLTs) and estimate the maximum tolerated dose of OMP-54F28 in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer.Study Period will be Approximately 12 to 21 months.OMP-54F28 will be administered IV on Days 1 and 15 of each 28-day cycle. Nab-paclitaxel and gemcitabine will be administered IV on Days 1, 8, and 15 of each cycle.Primary efficacy endpoint is objective response, defined as a complete or partial response, on the basis of investigator assessment.
Active, not recruiting | Pancreatic Cancer | Multisite
Heinz-Josef Lenz
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0C-15-4 A Phase 1a/1b Study of FPA008 in Combination with Nivolumab in Patients with Selected Advanced Cancers
| Kidney Cancer | Multisite
Anthony El-Khoueiry
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