A Phase 2 Trial of High-dose Ascorbate for Pancreatic Cancer (PACMAN 2.1)

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

November 28, 2018

Primary Completion Date

August 26, 2024

Study Completion Date

August 26, 2024

Conditions
Pancreatic NeoplasmsCancer of PancreasCancer of the PancreasNeoplasms, PancreaticPancreas CancerPancreas NeoplasmsAdenocarcinoma
Interventions
DRUG

Gemcitabine

"Administered intravenously the same day as nab-paclitaxel and ascorbate Administered after nab-paclitaxel and before ascorbate~* given for 3 weeks out of the 4 week cycle~* standard dose reductions are used~* up to 2 cycles are administered before standard of care CT scan~* decision to continue therapy is based disease response to therapy as measured from the CT scan~* treatment continues until disease progression is identified"

DRUG

nab-paclitaxel

"Administered intravenously the same day as nab-paclitaxel and ascorbate Administered after before gemcitabine and ascorbate~* given for 3 weeks out of the 4 week cycle~* standard dose reductions are used~* up to 2 cycles are administered before standard of care CT scan~* decision to continue therapy is based disease response to therapy as measured from the CT scan~* treatment continues until disease progression is identified"

DRUG

Pharmacological ascorbate

"Administered intravenously the same day as nab-paclitaxel and gemcitabine Administered after nab-paclitaxel and gemcitabine~* given 3 times weekly~* given for 4 weeks out of the 4 week cycle~* no dose reductions are used~* up to 2 cycles are administered before standard of care CT scan~* decision to continue therapy is based disease response to therapy as measured from the CT scan~* treatment continues until disease progression is identified"

Trial Locations (1)

52242

Holden Comprehensive Cancer Center, Iowa City

Sponsors
All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Cancer Institute (NCI)

NIH

collaborator

Holden Comprehensive Cancer Center

OTHER

collaborator

McGuff Pharmaceuticals, Inc.

INDUSTRY

lead

Joseph J. Cullen

OTHER

NCT02905578 - A Phase 2 Trial of High-dose Ascorbate for Pancreatic Cancer (PACMAN 2.1) | Biotech Hunter | Biotech Hunter