SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells

Recruiting Phase 1 Interventional Study
Pancreatic Adenocarcinoma Metastatic BRCA1 Mutation BRCA2 Mutation Pancreatic Acinar Cell Carcinoma Pancreatic Ductal Adenocarcinoma Pancreatic Cancer Metastatic Pancreatic Cancer Metastatic Pancreatic Ductal Adenocarcinoma Breast Cancer Metastatic Breast Cancer Stage IV Pancreatic Cancer Stage IV HER2-negative Breast Cancer HER2 Negative Breast Carcinoma Adenocarcinoma of the Breast PALB2 Gene Mutation Pancreas Cancer, Metastatic Pancreas Cancer, Recurrent Pancreas Cancer Stage IV Pancreatic Cancer Stage 4 Pancreatic Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
General Oncology, Inc. · Industry
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About This Trial
The clinical trial is a phase 1, single-arm trial that will evaluate the safety of the investigational treatment on metastatic pancreatic cancer and metastatic breast cancer. The investigational treatment will involve 2 cycles of a combination of intravenous melphalan, BCNU, vitamin B12b, and vitamin C with autologous hematopoietic stem cell infusion. A dose-escalation schedule is being employed f…
Trial Locations
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Eligibility Criteria
Inclusion Criteria * Age ≥ 18 years. * Pancreatic or breast cancer, as described below. * Stage IV (based on AJCC staging guidelines) at the time of enrollment. a. Note that potential subjects with stage IV cancer that have had a complete response from prior chemotherapy are still potentially el…
Contacts

General Oncology (study sponsor)

818-4-SHARON (818-474-2766)

contact@SharonTrial.com

CONTACT