scholarly journals A Phase I Open‐Label Clinical Trial Evaluating the Therapeutic Vaccine hVEGF26 –104/ RFASE in Patients with Advanced Solid Malignancies

2020 ◽  
Author(s):  
Ruben S.A. Goedegebuure ◽  
Madelon Q. Wentink ◽  
Hans J. Vliet ◽  
Peter Timmerman ◽  
Arjan W. Griffioen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Therapeutic Vaccine ◽  
Open Label ◽  
Solid Malignancies

scholarly journals DIPG-52. PHASE I CLINICAL TRIAL OF ONC201 IN PEDIATRIC H3 K27M-MUTANT GLIOMA OR NEWLY DIAGNOSED DIPG

2020 ◽  
Vol 22 (Supplement_3) ◽  
pp. iii297-iii297
Author(s):  
Sharon Gardner ◽  
Rohinton Tarapore ◽  
Jeffrey Allen ◽  
Wafik Zaky ◽  
Yazmin Odia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Body Weight ◽  
Phase I ◽  
Single Agent ◽  
High Grade Glioma ◽  
Newly Diagnosed ◽  
Liquid Formulation ◽  
Open Label ◽  
Dismal Prognosis ◽  
Expansion Cohort

Abstract H3 K27M-mutant gliomas often manifest as midline gliomas, have a dismal prognosis, and have no effective treatments. ONC201 efficacy has been shown in high-grade glioma preclinical models and durable responses with single agent ONC201 have been reported in adults with recurrent H3 K27M-mutant gliomas. These observations led to a Phase I pediatric clinical trial of ONC201 dosed by body weight. This multi-center, open-label, 3 + 3 dose-escalation and dose-expansion clinical trial (NCT03416530) for H3 K27M-mutant glioma or non-biopsied DIPG has 6 arms: arms A and E determine the RP2D in pediatric post-radiation (recurrent or not-recurrent) H3 K27M-mutant glioma patients with ONC201 administered as an oral capsule as well as a liquid formulation, respectively. Both arms have completed accrual. The study is currently enrolling newly diagnosed DIPG patients to determine the RP2D for ONC201 in combination with radiation (arm B). Dedicated assessment of intratumoral ONC201 concentrations in midline gliomas patients (arm C) and the effects of ONC201 in H3K27M DNA levels in circulating CSF (arm D) are currently enrolling patients. ONC201 as a single agent in patients with progressive H3K27M mutant tumors following irradiation (excluding DIPG/spinal cord tumors) was recently opened (arm F). Once the RP2D is confirmed, there is a dose-expansion cohort to confirm the safety, radiographic efficacy and survival with ONC201. The primary endpoints of arms A, B, and E have been established with the RP2D of 625mg scaled by body weight as a capsule or liquid formulation administered alone or in combination with radiation without incidence of dose-limiting toxicity.

30. Open-label Phase I/II clinical trial of pyrimethamine for the treatment of chronic GM2 gangliosidosis

2010 ◽  
Vol 99 (2) ◽  
pp. S14 ◽  
Author(s):  
Joe Clarke ◽  
Edwin Kolodny ◽  
Don Mahuran ◽  
Maria Fuller ◽  
Michael Tropak ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Gm2 Gangliosidosis ◽  
Open Label ◽  
Open Label Phase

GTL001, A Therapeutic Vaccine for Women Infected with Human Papillomavirus 16 or 18 and Normal Cervical Cytology: Results of a Phase I Clinical Trial

2016 ◽  
Vol 22 (13) ◽  
pp. 3238-3248 ◽  
Author(s):  
Pierre Van Damme ◽  
Myriam Bouillette-Marussig ◽  
Annick Hens ◽  
Ilse De Coster ◽  
Christophe Depuydt ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Human Papillomavirus ◽  
Phase I ◽  
Therapeutic Vaccine ◽  
Phase I Clinical Trial ◽  
Cervical Cytology ◽  
Human Papillomavirus 16 ◽  
Normal Cervical Cytology

Phase I Clinical Trial of Irinotecan With Oral Capecitabine in Patients With Gastrointestinal and Other Solid Malignancies

2002 ◽  
Vol 25 (5) ◽  
pp. 528-534 ◽  
Author(s):  
Sanjay Goel ◽  
Minaxi Jhawer ◽  
Lakshmi Rajdev ◽  
Una Hopkins ◽  
Karen Fehn ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Phase I Clinical Trial ◽  
Oral Capecitabine ◽  
Solid Malignancies

A phase I/II study combining tosedostat with capecitabine in patients with metastatic pancreatic adenocarcinoma.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. TPS471-TPS471
Author(s):  
Andrea S. Teague ◽  
Manik A. Amin ◽  
Kian-Huat Lim ◽  
Albert C. Lockhart ◽  
Ashiq Masood ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Amino Acids ◽  
Phase I ◽  
Phase Ii ◽  
Primary Objective ◽  
Cellular Stress Response ◽  
Ductal Adenocarcinoma ◽  
Open Label ◽  
Pancreatic Cancer Cells ◽  
Dismal Prognosis

TPS471 Background: Metastatic pancreatic ductal adenocarcinoma (PDAC) has a dismal prognosis. Recent advances with fluorouracil in combination with oxaliplatin and irinotecan (FOLFIRINOX) and nab-paclitaxel combined with gemcitabine (AG) have improved survival in patients with PDAC. A fluorouracil-based regimen is recommended for patients who progress after a gemcitabine-based regimen. Tosedostat is an oral aminopeptidase inhibitor shown to have anti-proliferative effects in malignancies. Aminopeptidase inhibitors disrupt the cleavage of amino acids from peptides downstream of proteasomal degradation, preventing the recycling of amino acids needed for new protein synthesis. This leads to intracellular depletion of amino acids, resulting in a cellular stress response known as the amino acid deprivation response, which leads to apoptosis. Because pancreatic cancer cells frequently upregulate expression of these aminopeptidases, aminopeptidases inhibitors hold therapeutic promise. Methods: This is a single institution phase I/II open-label trial to evaluate the safety and tolerability of tosedostat plus capecitabine in patients with metastatic PDAC that have progressed after a gemcitabine-based regimen. The phase I part will be conducted in a dose de-escalation fashion, with two planned dose levels of tosedostat (120mg or 60mg) p.o. daily on days 1 to 21 with capecitabine 1000 mg/m2 p.o. BID on days 1 to 14 of a 21-day cycle. If more than one patient in the tosedostat (120 mg) cohort experiences a dose limiting toxicity (DLT), then 6 more patient will be enrolled to the tosedostat (60 mg) cohort. A total of 36 patients will be enrolled in the phase II portion. Primary objective of the phase I portion is to determine the maximum tolerated dose and DLTs of tosedostat and capecitabine combination therapy. Primary objective of the phase II portion is to determine the progression-free survival at 3 months. Secondary objectives are to determine the overall response rate, time-to-progression, overall survival and CA 19-9 response. Exploratory objectives are to explore the predictive molecular biomarkers for treatment response and to explore the prognostic biomarkers. Clinical trial: NCT02352831. Clinical trial information: NCT02352831.

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