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Intractable Cancer PainPhase 1NCT03226574

Study to Evaluate Safety and MTD of Epidural Resiniferatoxin Injection for Treatment of Intractable Cancer Pain

A Phase 1 study testing Resiniferatoxin in people with Intractable Cancer Pain, run by Sorrento Therapeutics, Inc. at 4 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

The study is a multicenter, open-label Phase 1b single dose escalation safety study for adult subjects with intractable pain associated with cancer in any area below the mid-thoracic level who meet all other eligibility criteria. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intractable Cancer Pain
What is being tested?
Resiniferatoxin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
4 sitesUnited States
Study dates
1 Sep 2017to 18 Jun 2020
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Histologically confirmed advanced cancer or metastasis, which has not responded to standard therapy, producing intractable chronic pain in any area below the mid-thoracic level.
  • Male or female subjects must be at least 18 years of age.
  • Must have a worst pain score ≥6 on the NPRS at Screening visit.
  • Subjects not seeking or receiving potentially curative therapies for cancer. Palliative therapy is acceptable if the therapy started and is stable prior to IP administration.
  • Sexually active female subjects of childbearing potential and male subjects capable of fathering a child must be willing to use an effective method of contraception to avoid pregnancies.
  • Must be willing and capable of understanding and cooperating with the requirements of the study.
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  • Must be able to understand and complete study-related forms and adequately communicate with the investigator and/or site staff.
  • Must have provided written informed consent prior to participating in any study-related activity.
  • Subjects able to complete the study duration.

Who cannot join

  • Subjects with leptomeningeal metastases in lumbar area.
  • Undergoing or have plans to undergo changes to current cancer treatment during the study through the Day15 assessment.
  • Had prior lumbar spine surgical procedures that could impair the ability to perform the injection.
  • Evidence of brain pathology or increase intracranial pressure.
  • Presence of an IT shunt.
  • Has evidence or a coagulopathy or hemostasis problem.
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  • Subjects with a total neutrophil count <1500 cells/mm3.
  • Subjects with serum creatinine ≥1.5 mg/dL.
  • Is febrile or has other evidence of an infection within 7 days of planned injection.
  • Has an allergy or hypersensitivity to chili peppers, capsaicin, or radiographic contrast agents.
  • Female subjects who are pregnant, are planning on becoming pregnant, or are currently breastfeeding.
  • Subjects with any medical condition that could adversely impact study participation or assessments.
  • Subjects who have received new anti-cancer treatments and there is less than one week or four half-lives of the investigational drug, whichever is greater, between the last dose of the new drug and the planned day of IP administration; or had a change in the dose or schedule of the anti-cancer treatments within one week or four half-lives, whichever is greater, between the last dose of the anti-cancer treatment and the planned day of IP administration; or are scheduled to receive a new anti-cancer therapy or investigational product prior to completion of the Day 15 visit.
  • Subjects with additional loci of pain above the mid-thoracic level or other pain disorder due to non-cancer etiology, unless both the investigator and the subject are clearly able to distinguish the additional pain from the target pain due to cancer.
  • Liver cirrhosis or severe hepatic impairment, with liver function test 3 times above ULN.
  • Sensory/peripheral neuropathy of CTCAE Grade 2 or higher.
  • Nonstudy related minor surgical procedure ≤5 days or major surgical procedure ≤21 days prior to Screening visit.
  • Subjects who have not completely recovered from any toxicities from previous chemotherapy, hormone therapy, immunotherapy, or radiotherapies that are CTCAE Grade 3 or higher.
  • Arterial thrombi (including stroke), myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting within 3 months prior to Screening visit.
  • Corrected QT using Fridericia's formula (QTcF) prolongation.
  • Evidence or history of bleeding disorder within 4 weeks prior to IP administration.
  • Known HIV or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or C.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Hermann Drive Surgical Hospital

    Houston, Texas, 77004

  • University of Miami/Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: A Multicenter, Open-Label, Phase 1b Study to Assess the Safety and Define the Maximally Tolerated Dose of Epidural Resiniferatoxin Injection for the Treatment of Intractable Pain Associated With Cancer

The study is a multicenter, open-label Phase 1b single dose escalation safety study for adult subjects with intractable pain associated with cancer in any area below the mid-thoracic level who meet all other eligibility criteria.

Read the detailed description

All subjects who received RTX will be included in the analyses and summaries of safety, efficacy, PD, and PK assessments.

Being tested
Resiniferatoxin
Keywords
Resiniferatoxin, RTX, Cancer pain
Medical subject headings
Cancer Pain

What participants receive

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

  • ResiniferatoxinDrug

    Also called RTX

    single dose (0.4, 1, 2, 4, 8,15, 25 or 35 mcg), epidural injection

Study groups in NCT03226574
Study groupRoleWhat they receive
RTX epidural injectionExperimentalEpidural injection of 1.5mL/min RTX under the guidance of epidurogram.
Receives: Drug: Resiniferatoxin

What is being measured

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

  1. Dose limiting toxicity (DLT)

    Grade 3 or 4 Toxicity associated with RTX administration

    Measured: 3-month

  2. Maximum tolerated dose (MTD)

    Maximum dose without a Grade 3 or 4 toxicity

    Measured: 3-month

Secondary outcomes (1)

  1. Numeric Pain Rating Scale (NPRS)

    Daily average pain and daily worst pain on a 0-10 scale

    Measured: Day-28 to Day90 daily

Timeline

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

  1. First posted24 Jul 2017
  2. Study start1 Sep 2017
  3. Primary completion18 Mar 2020
  4. Study completion18 Jun 2020

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
The design uses a traditional "3+3" rule-based design that does not stipulate any prior assumption of the dose-toxicity curve. Dose escalation is permitted between successive cohorts based upon a specified algorithm, using discrete dosage steps.
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03226574
Sponsor's protocol ID
RTX-001
Status last verified
Oct 2020
First submitted
6 Jul 2017
Last updated
20 Oct 2020
Results posted
No
Data monitoring committee
Yes
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 study testing Resiniferatoxin in people with Intractable Cancer Pain, run by Sorrento Therapeutics, Inc. at 4 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 9 inclusion and 22 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 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 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.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Dose limiting toxicity (DLT) (time frame: 3-month). The study lists 2 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 NCT03226574.

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 20 Oct 2020.

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