A 2 week lead-in monotherapy of ARQ-761 (The amount of ARQ-761 that will be given to the participant will depend on the time at which the participant was enrolled in the study
Afterwards the 28-day cycle of combination treatment of ARQ-761 along with gemcitabine (1000 mg/m2) + nab-paclitaxel (125 mg/m2) will begin.

Pancreatic Cancer

Dose Level 1:
ARQ761 195 mg IV D1, D15 Gemcitabine 1000 mg/m2 D1, 8, 15 Nab paclitaxel 125 mg/m2 D1, 8, 15
Dose Level 2:
ARQ761 290 mg IV D1, D15 Gemcitabine 1000 mg/m2 D1,8,15
Dose Level 3:
ARQ761 390 mg IV D1, D15 Gemcitabine 1000 mg/m2 D1,8,15 Nab-paclitaxel 125 mg/m2 D1,8,15
Expansion Dose Level:
ARQ761 390 IV mg or as tolerated D1, 15 Gemcitabine 1000 mg/m2 D1,8,15 Nab-Paclitaxel 125 mg/m2 D1,8,15

ARQ-761

Therapy after lead in Phase:
You will receive Gemcitabine (1000mg/m2) administered intravenously on Days 1,8, 15-every 28 days. All cycles are 28 days in duration and there are no rest periods between cycles. You may continue treatment after cycle 6 until disease progression.

Gemcitabine

Therapy after lead in phase:
You will receive nab-paclitaxel (125 mg/m2) administered intravenously on Days 1,8, 15-every 28 days. All cycles are 28 days in duration and there are no rest periods between cycles. You may continue treatment after cycle 6 until disease progression.

nab-paclitaxel

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

UT Southwestern Medical Center

ARQ-761 Treatment With Gemcitabine/Nab-Paclitaxel Chemotherapy In Pancreatic Cancer

A Phase I/Ib, Single-Arm, Open-Label, Multi-Center Trial Using ARQ-761 (Beta-Lapachone) Treatment With Gemcitabine/Nab-Paclitaxel Chemotherapy In Metastatic, Unresectable, Or Recurrent Pancreatic Cancer

Determine the maximum tolerated dose (MTD) of ARQ761 when given in combination with gemcitabine and nab-paclitaxel (GEM-Nab-Pac).

Safety will be assessed by quantifying toxicities using the NCI's CTCAE v4.0 toxicity criteria.

CT Chest/Abdomen/Pelvis to determine clinical activity as defined by overall response rate (ORR).

CT Chest/Abdomen/Pelvis to determine clinical activity as defined by Progression Free Survival .

CT Chest/Abdomen/Pelvis to determine clinical activity as defined by Time To Progression.

The pharmacokinetic profile of ARQ761 will be determined by measurement of blood levels at predetermined time points.

Tolerability will be assessed by quantifying toxicities using the NCI's CTCAE v4.0 toxicity criteria.

beta lapachone/neoplasms

ARQ-761 Treatment With Gemcitabine/Nab-Paclitaxel Chemotherapy In Pancreatic Cancer

An Exploratory Biomarker Study of ARQ 501 in Patients With Advanced Solid Tumors

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