RX-3117 in Combination With Abraxane® in Subjects With Metastatic Pancreatic Cancer

NCT03189914 | Completed Phase 1 Results FDA Drug

• 1 other identifier: RX3117-003
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 10

Brief Summary

This will be a Phase 1b/2a multicenter 2-stage study. Phase 1 will be conducted as a dose-finding, open-label study of oral RX-3117 administered in combination with Abraxane® to subjects with metastatic pancreatic cancer. After completion of the Phase 1 portion, a Phase 2a study will be conducted using a 2 stage, open-label design, of RX 3117 and Abraxane® in combination to treat subjects with metastatic pancreatic cancer as first line therapy.

Conditions

Metastatic Pancreatic Cancer

Keywords

pancreatic cancer; Abraxane; first line

Outcome Measures

Primary Outcomes (6)

• Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 (Phase 1 and 2)

  Number of participants who experienced a treatment-related adverse event

  9 months

• Number of Participants With Clinical Laboratory Abnormalities (Phase 1 and 2)

  Participants with adverse events coded using the MedDRA Dictionary (Version 20.0) to Investigations. Due to the underlying disease, not all abnormal labs are reported.

  9 months

• Number of Participants With Vital Sign Abnormalities (Phase 1 and 2)

  Number of participants with clinically significant vital sign abnormalities (Phase 1 and 2) including heart rate, respiration rate, and blood pressure

  9 months

• Number of Participants With Electrocardiogram (ECG) Abnormalities (Phase 1 and 2)

  Number of participants with clinically significant ECG abnormalities (Phase 1 and 2)

  1 month

• Number of Dose-limiting Toxicities (DLTs) (Phase 1)

  4 weeks

• Number of Participants With Progression Free Survival (PFS) and/or Objective Clinical Response (Phase 2)

  Participants must have progression Free Survival (PFS) \> 4 months or objective clinical response (complete or partial response).

  9 months

Secondary Outcomes (17)

• Area Under the Plasma Concentration Versus Time Curve (AUC) of RX-3117 (Phase 1 and Phase 2) - Day 1

  Cycle 1 Day 1 (pre-infusion, post-infusion, pre-dose RX-3117, and 0.5, 1, 2, 4, 6, and 24 hours after administration)

• Time to Maximum Observed Concentration [Tmax] of RX-3117 (Phase 1 and Phase 2) - Day 1

  Cycle 1 Days 1 (pre-infusion, post-infusion, pre-dose RX-3117, and 0.5, 1, 2, 4, 6, and 24 hours after administration)

• Maximum Observed Concentration [Cmax] of RX-3117 (Phase 1 and Phase 2) - Day 1

  Cycle 1 Days 1 (pre-infusion, post-infusion, pre-dose RX-3117, and 0.5, 1, 2, 4, 6, and 24 hours after administration)

• Overall Response Rate [ORR] (Phase 1 and Phase 2)

  Every 8 weeks until progression or discontinuation, whichever came first, assessed up to 32 weeks

• Time to Response [TTR] (Phase 1)

  Up to 32 weeks

Other Outcomes (3)

• Exploratory Measurement of Protein Biomarkers Related to RX-3117 or Pancreatic Cancer (Phase 1 and 2)

  Baseline, and at 8, 6, 24, and 32 weeks

• Tumor Burden Response (Phase 2)

  Baseline, and at 8, 6, 24, and 32 weeks

• Quality of Life (QOL) (Phase 1 and 2)

  9 months

Study Arms (1)

RX-3117 + Abraxane

EXPERIMENTAL

RX-3117: oral, 500 - 700 mg/ day for 5 days on/ 2 days off for 3 weeks. 1 washout week/ cycle. Abraxane: 75 - 125 mg/m\^2, infused once per week for 3 weeks. 1 washout week/ cycle.

Drug: RX-3117

Interventions

RX-3117 DRUG

RX-3117 will be administered orally in combination with Abraxane.

Also known as: Abraxane

RX-3117 + Abraxane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Disease Related
• Subject has confirmed histologic or cytologic evidence of metastatic pancreatic cancer and has no prior treatment for metastatic pancreatic cancer.
• Subject has measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.
• Subject has a life expectancy of at least 3 months.
• Subject has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Demographic
• Males or females ≥ 18 years of age
• Subject must be able to swallow capsules
• Subject must have adequate venous access for intravenous (IV) infusion
• Laboratory
• Subject has hemoglobin ≥ 9.0 g/dL at Screening
• Subject has absolute neutrophil count (ANC) ≥ 1.5 x 109/L at Screening
• Subject has platelet count ≥ 100 x 109/L at Screening
• Subject has serum creatinine ≤ 1.5 times the upper limit of normal (ULN) at Screening. Subjects with serum creatinine levels \> 1.5 times the ULN must have a 24-hour urine creatinine clearance ≥ 60 mL/min
• Subject has serum bilirubin ≤ 1.5 times the ULN (except in subjects with Gilbert's Syndrome who must have serum bilirubin \< 3.0 x ULN)

You may not qualify if:

• Disease Related
• Subject has primary brain tumors or clinical evidence of active brain metastasis
• Subject has undergone major surgery within 4 weeks of the start of study treatment. Laparoscopy and central venous catheter placement are not considered major surgery
• Medications
• Subject has a history of systemic corticosteroid use within 7 days before Day 1 of Cycle 1
• General
• Subject has an active infection requiring parenteral or oral antibiotics within 2 weeks before planned start of study therapy
• Subject has uncontrolled diabetes as assessed by the investigator
• Subject has a second malignancy other than curatively resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or other cancers treated with curative intent and no known active disease within 3 years before planned start of study therapy
• Subject has an active infection of hepatitis B, hepatitis C or human immunodeficiency virus
• Female subjects who are pregnant, planning a pregnancy or breast feeding during the study
• Subject has a high cardiovascular risk, including, but not limited to, subjects with congestive heart failure (New York Heart Association \[NYHA\] Class III or IV), cardiac arrhythmia, unstable angina, coronary stenting or acute coronary syndromes within 6 months before planned start of study therapy or r myocardial infarction within one year before planned start of study therapy
• Criterion removed
• Subject has a history of prior allogeneic bone marrow progenitor cell or solid organ transplantation.
• Subject has known acute or chronic pancreatitis.

Sponsors & Collaborators

• Processa Pharmaceuticals: lead

Study Sites (10)

Rexahn Site

Tucson, Arizona, 85724, United States

Location

Rexahn Site

Weeki Wachee, Florida, 34607, United States

Location

Rexahn Site

Joliet, Illinois, 60435, United States

Location

Rexahn Site

Skokie, Illinois, 60077, United States

Location

Rexahn Site

Lexington, Kentucky, 40503, United States

Location

Rexahn Site

Boston, Massachusetts, 02115, United States

Location

Rexahn Site

New York, New York, 10065, United States

Location

Rexahn Site

Spartanburg, South Carolina, 29303, United States

Location

Rexahn Site

Spokane, Washington, 99202, United States

Location

Rexahn Site

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

fluorocyclopentenylcytosine; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Doug Swirsky/ Chief Executive Officer
• Organization: Rexahn

swirskyd@rexahn.com

12402685300

Study Officials

• Ely Benaim, MD

  Rexahn Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 16, 2017
• Study Start: October 2, 2017
• Primary Completion: October 1, 2019
• Study Completion: November 21, 2019
• Last Updated: December 6, 2023
• Results First Posted: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)