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Metastatic Pancreatic CancerPhase 1/2NCT03189914

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

A Phase 1/2 study testing RX-3117 in people with Metastatic Pancreatic Cancer, run by Processa Pharmaceuticals at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
RX-3117
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
10 sitesUnited States
Study dates
2 Oct 2017to 21 Nov 2019
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 28Show fewer
  • 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)
  • Subject has aspartate aminotransferase (AST; SGOT) and alanine aminotransferase (ALT; SGPT) ≤ 2.5 times the ULN (OR, AST and ALT ≤ 5 times the ULN in the presence of known liver metastases)
  • Subject has alkaline phosphatase ≤ 2.5 times the ULN (OR ≤ 5 times the ULN in the presence of known liver or bone metastases)
  • Subject has normal coagulation parameters (prothrombin time [PT] and/or international normalized ratio [INR], and partial thromboplastin time [PTT] within normal limits [<1.2 x ULN])
  • Subject has potassium concentration within normal range, or correctable with supplements.
  • Oxygen saturation by pulse oximetry ≥ 92% at rest.
  • For women of childbearing potential: Negative serum pregnancy test during screening and negative serum or urine pregnancy test at start of study therapy (Cycle1 Day 1).
  • Reproductive
  • For female subjects of childbearing potential, willingness to abstain from heterosexual intercourse or use a protocol-recommended method of contraception from the screening visit throughout the study treatment period and for 30 days following the last dose of study drug.
  • Female subjects of non-childbearing potential defined as having amenorrhea for at least 24 consecutive months, a documented hysterectomy, or a documented bilateral oophorectomy)
  • For fertile male subjects having intercourse with females of childbearing potential, willingness to abstain from heterosexual intercourse or use a protocol-recommended method of contraception from the start of study therapy throughout the study treatment period and for 30 days following the last dose of study drug and to refrain from sperm donation from the start of study treatment throughout the study treatment period and for 30 days following the last dose of study drug.
  • Ethical
  • In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the subject's cancer.
  • Before any study-specific procedure, the appropriate written informed consent must be obtained

Who cannot join

  • 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
Show all 23Show fewer
  • 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.
  • Subject has persistent diarrhea, malabsorption, or known sub-acute bowel obstruction ≥ NCI CTCAE Grade 2, despite medical management.
  • Subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery and bariatric surgery)
  • All acute toxic effects of any prior antitumor therapy resolved to Grade ≤ 1 before the start of study therapy (with the exception of alopecia [Grade 1 or 2 permitted], or neurotoxicity [Grade 1 or 2 permitted], or anemia [Grade 2 permitted])
  • Subject has any other medical, psychiatric, or social condition, which in the opinion of the investigator, would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of the study results
  • Subject has a history of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies. Any lung disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity.
  • Subject is currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices, or investigational drug.
  • Subject has a history of hypersensitivity to RX-3117, gemcitabine, azacytidine cytosine arabinoside, paclitaxel, nab-paclitaxel, or their excipients.
  • Subject is unwilling or unable to comply with study requirements or planned unavailability for follow-up assessments.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Rexahn Site

    Boston, Massachusetts, 02115

  • Rexahn Site

    Joliet, Illinois, 60435

  • Rexahn Site

    Lexington, Kentucky, 40503

  • Rexahn Site

    Milwaukee, Wisconsin, 53226

  • Rexahn Site

    New York, New York, 10065

  • Rexahn Site

    Skokie, Illinois, 60077

  • Rexahn Site

    Spartanburg, South Carolina, 29303

  • Rexahn Site

    Spokane, Washington, 99202

  • Rexahn Site

    Tucson, Arizona, 85724

  • Rexahn Site

    Weeki Wachee, Florida, 34607

Other trials in United States

About this study

Official title: A Phase 1/2 Open-Label, Safety, Pharmacokinetic, Pharmacodynamic and Efficacy Study of RX-3117 in Combination With Abraxane® in Subjects With Metastatic Pancreatic Cancer

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.

Read the detailed description

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. The recommended phase 2 dose (RP2D) and schedule of RX-3117, in combination with Abraxane®, will be determined based on the safety profile, dose modification, and pharmacokinetics (PK). Phase 1 will be conducted using a combination of the single agent maximum tolerated dose (MTD) for RX-3117 and the Abraxane dose as per the package insert for patients with pancreatic cancer in combination with gemcitabine.

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. Approximately 10 subjects will participate in the Stage 1 at the dose identified in Phase 1 (RP2D). Subjects will be treated for up to 8 cycles of combined therapy. An interim analysis will be conducted after 10 evaluable subjects have been treated at the RP2D, have completed a minimum of 4 cycles of therapy, or have discontinued therapy due to progressive disease before completing 4 cycles. If an adequate number of Responders are observed out of the initial 10 evaluable subjects, then 40 additional subjects will be enrolled to participate in Stage 2. Subjects will be treated for up to 8 cycles of combined therapy.

Being tested
RX-3117
Keywords
pancreatic cancer, Abraxane, first line
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RX-3117Drug

    Also called Abraxane

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

Study groups in NCT03189914
Study groupRoleWhat they receive
RX-3117 + AbraxaneExperimentalRX-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.
Receives: Drug: RX-3117

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 9 months

  2. 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.

    Measured: 9 months

  3. 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

    Measured: 9 months

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

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

    Measured: 1 month

  5. Number of Dose-limiting Toxicities (DLTs) (Phase 1)

    Measured: 4 weeks

  6. 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).

    Measured: 9 months

Secondary outcomes (17)

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

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

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

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

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

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

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

    Overall Response Rate will be based on the RECIST v1.1 and is defined as the percentage of subjects meeting criteria of Complete Response (CR) or Partial Response (PR). CR or PR must be confirmed at least 4 weeks after the date of the original CR or PR.

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

  5. Time to Response [TTR] (Phase 1)

    Measured: Up to 32 weeks

  6. Duration of Response [DOR] (Phase 1 and Phase 2)

    Duration of response is defined as the time from documentation of response to disease progression.

    Measured: Up to 32 weeks

  7. Progression-free Survival [PFS] (Phase 1)

    Progression Free Survival defined as the percentage of subjects who are alive in the study and not in progression.

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

  8. Time to Progression (Phase 2)

    Time to Progression defined as the time from first treatment administration to first documentation of RECIST-defined objective tumor progression.

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

  9. Area Under the Plasma Concentration Versus Time Curve (AUC) of RX-3117 and Abraxane® (Phase 1 and Phase 2) - Day 15

    Measured: Day 15 (pre-infusion, post-infusion, pre-dose RX-3117, and 0.5, 1, 2, 4, and 6 hours after administration)

  10. Area Under the Plasma Concentration Versus Time Curve (AUC) of Abraxane® (Phase 1 and Phase 2) - Day 1

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

  11. Area Under the Plasma Concentration Versus Time Curve (AUC) of Abraxane®(Phase 1 and Phase 2) - Day 15

    Measured: Day 15 (pre-infusion, post-infusion, pre-dose RX-3117, and 0.5, 1, 2, 4, and 6 hours after administration)

  12. Time to Maximum Observed Concentration [Tmax] of RX-3117 (Phase 1 and Phase 2) - Day 15

    Measured: Day 15 (pre-infusion, post-infusion, pre-dose RX-3117, and 0.5, 1, 2, 4, and 6 hours after administration)

  13. Time to Maximum Observed Concentration [Tmax] of Abraxane® (Phase 1 and Phase 2) - Day 1

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

  14. Time to Maximum Observed Concentration [Tmax] of Abraxane® (Phase 1 and Phase 2) - Day 15

    Measured: Day 15 (pre-infusion, post-infusion, pre-dose RX-3117, and 0.5, 1, 2, 4, and 6 hours after administration)

  15. Maximum Observed Concentration [Cmax] of RX-3117 (Phase 1 and Phase 2) - Day 15

    Measured: Day 15 (pre-infusion, post-infusion, pre-dose RX-3117, and 0.5, 1, 2, 4, and 6 hours after administration)

  16. Maximum Observed Concentration [Cmax] of Abraxane (Phase 1 and Phase 2) - Day 1

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

  17. Maximum Observed Concentration [Cmax] of Abraxane (Phase 1 and Phase 2) - Day 15

    Measured: Day 15 (pre-infusion, post-infusion, pre-dose RX-3117, and 0.5, 1, 2, 4, and 6 hours after administration)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2017
  2. Study start2 Oct 2017
  3. Primary completion1 Oct 2019
  4. Study completion21 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03189914
Sponsor's protocol ID
RX3117-003
Status last verified
Nov 2023
First submitted
7 Jun 2017
Last updated
6 Dec 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing RX-3117 in people with Metastatic Pancreatic Cancer, run by Processa Pharmaceuticals at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 (Phase 1 and 2) (time frame: 9 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03189914.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.

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