NCT03076216: OncoPaC-1

A Pilot Study of OncoSil™ Given to Patients With Pancreatic Cancer Treated With Gemcitabine +/- Nab-paclitaxel.

Completed NA Last updated 13 July 2021

What this trial tests

NA trial testing OncoSil™ in Unresectable Locally Advanced Pancreatic Carcinoma in 9 participants. Completed in 28 November 2020.

Timeline

1 August 2017

Primary endpoint
28 November 2020

28 November 2020

Quick facts

Lead sponsor	OncoSil Medical Limited
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	1 August 2017
Primary completion	28 November 2020
Estimated completion	28 November 2020
Sites	4 locations across United States

Drugs / interventions tested

• OncoSil™

Conditions studied

• Unresectable Locally Advanced Pancreatic Carcinoma — all drugs for Unresectable Locally Advanced Pancreatic Carcinoma →

Sponsor

OncoSil Medical Limited — full company profile →

Who can join

18 and older, any sex, with Unresectable Locally Advanced Pancreatic Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To evaluate the safety of OncoSil™ in a patient population undergoing standard chemotherapy treatment for pancreatic cancer. This study has been designed to satisfy FDA regulatory requirements.

The clinical investigation will be conducted at approximately 5 sites in the United States involving 20 patients.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nano albumin bound-paclitaxel in pancreatic cancer: Current evidences and future directions.
   Giordano G, Pancione M, Olivieri N, Parcesepe P, et al · · 2017 · cited 67× · PMID 28932079 · DOI 10.3748/wjg.v23.i32.5875
2. An open-label, single-arm pilot study of EUS-guided brachytherapy with phosphorus-32 microparticles in combination with gemcitabine +/- nab-paclitaxel in unresectable locally advanced pancreatic cancer (OncoPaC-1): Technical details and study protocol.
   Bhutani MS, Klapman JB, Tuli R, El-Haddad G, et al · · 2020 · cited 23× · PMID 31670288 · DOI 10.4103/eus.eus_44_19
3. Novel EUS-guided brachytherapy treatment of pancreatic cancer with phosphorus-32 microparticles: first United States experience.
   Bhutani MS, Cazacu IM, Luzuriaga Chavez AA, Singh BS, et al · · 2019 · cited 13× · PMID 31065616 · DOI 10.1016/j.vgie.2019.02.009
4. Porous Silicon as a Platform for Radiation Theranostics Together with a Novel RIB-Based Radiolanthanoid.
   Jakobsson U, Mäkilä E, Airaksinen AJ, Alanen O, et al · · 2019 · cited 6× · PMID 30992696 · DOI 10.1155/2019/3728563
5. POSTER PRESENTATIONS
   · 2018 · cited 1×
6. POSTER PRESENTATIONS
   · 2018