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

• Status: Suspended
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study of ARQ-761 (beta-lapachone) with gemcitabine/nab-paclitaxel chemotherapy in subjects with advanced (metastatic, unresectable, or recurrent) pancreatic cancer that has not been treated with gemcitabine.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Albumin-Bound Paclitaxel; Beta-lapachone; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

1. Subjects must have a histologically or cytologically confirmed pancreatic adenocarcinoma that is metastatic, unresectable, or recurrent.

2. Has received at most 1 line of prior non-gemcitabine chemotherapy for:

• metastatic/unresectable disease.

• Prior adjuvant gemcitabine, if completed more than 12 months prior to enrollment is not considered as prior line of therapy.

• Radiosensitizing chemotherapy will not be considered a prior line of therapy.

3. Prior and concurrent therapy4. Measurable disease is required per RECIST criteria 1.1.

5. Age ≥18 years. 6. ECOG performance status 0 or 1 7. Anticipated life expectancy ≥ three months. 8. Central venous access 9. Availability of unstained slides or paraffin block tissue from archived tumor specimen. If not available the subject will undergo a fresh biopsy.

10. Specific pretreatment clinical laboratory parameters that are required within 14 days prior to registration.

11. Subjects must be recovered from any toxicity related to prior anti-neoplastic therapy (to grade <1).

12. Women of child-bearing potential and men must agree to use adequate contraception hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.

Exclusion Criteria:

1. Receiving any other investigational agents.

2. Subjects with known untreated brain metastases.

3. Subjects receiving hepatic enzyme-inducing antiseizure drugs ("EIASD

4. Uncontrolled intercurrent illness

5. Pregnancy

6. Any significant medical condition, laboratory abnormality, or psychiatric illness. 7. Any condition including the presence of laboratory abnormalities.

8. Any condition that confounds the ability to interpret data from the study. 9. Unwillingness or inability to comply with study procedures.