Malignant Solid TumorPhase 1PAYLOADNCT02801097
RRx-001 in Combination With Irinotecan in Metastatic or Advanced Cancer (PAYLOAD)
A Phase 1 study testing RRx-001 and Irinotecan in people with Malignant Solid Tumor and Metastatic Cancer, run by EpicentRx, Inc. at 2 sites in United States.
Trial summary
This is a phase 1 open-label trial to evaluate the safety, pharmacodynamics and clinical activity of RRx-001 administered in combination with irinotecan. RRx-001 is associated with resensitization to irinotecan in tumors that are previously refractory. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Tumor, Metastatic Cancer, Advanced Cancer
- What is being tested?
- RRx-001 and Irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Aug 2016to 9 Dec 2019
- 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 or cytologically confirmed diagnosis of an advanced, malignant, solid tumor(s) with all standard treatment options having been exhausted or declined.
- Eastern Cooperative Group (ECOG) performance status is 0-2 at Screening.
- Measurable disease per RECIST v1.1 by radiographic techniques
- Acceptable liver function, serum creatinine and hematological status
- Female subjects of childbearing potential, and male subjects with partners of childbearing potential, must agree to use medically acceptable methods of contraception beginning on Study Day 1 and continuing until at least four weeks after administration of the subject's final dose of RRx-001.
- Subjects with brain metastases are eligible
Who cannot join
- Concurrent anticancer therapy; however, radiotherapy is allowed
- Any history of hypersensitivity to irinotecan
- Cholangitis that required treatment or intervention within 4 weeks of study enrollment
- Bilirubin > 2.0 mg/dL
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- If female, subject is pregnant and/or breastfeeding.
- UGT1A1*28 homozygote or heterozygote
- BMI >35
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
University of California, Davis
Sacramento, California, 95817
About this study
Official title: A Phase I, Open-Label, Multiple Ascending Dose Study to Assess the Safety and Tolerability of RRx-001 in Combination With Irinotecan in Metastatic or Advanced Cancer Patients Without Life-Prolonging Therapies of Demonstrated Clinical Benefit (PAYLOAD)
This is a phase 1 open-label trial to evaluate the safety, pharmacodynamics and clinical activity of RRx-001 administered in combination with irinotecan.
RRx-001 is associated with resensitization to irinotecan in tumors that are previously refractory. This effect has been attributed to the ability of RRx-001 to restore the expression of aberrantly silenced genes, thus re-establishing pathway functions. However, resensitization may have more than one mechanism, among them Pgp pump inhibition and vascular modulation, leading to improved penetration of standard chemotherapy.
Read the detailed description
This dose escalation study consists of 5 sequential dose cohorts each administered RRx-001 with irinotecan. After the first 3 subjects of each cohort complete Cycle 1, the safety will be assessed before moving to the next dose level. Subjects in the current cohort will continue treatment immediately following the completion of Cycle 1, for as long as therapy is tolerated and the RECIST v.1.1 definition of progression is not met.
- Conditions
- Malignant Solid Tumor, Metastatic Cancer, Advanced Cancer
- Being tested
- RRx-001, Irinotecan
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RRx-001Drug
IrinotecanDrug
| Study group | Role | What they receive |
|---|---|---|
| RRx-001 + Irinotecan | Experimental | Cohorts of participants with an advanced, malignant, solid tumor(s) will receive weekly doses of RRx-001 for 3 weeks, switching at week 4 to every-other-week treatments of RRx-001 with irinotecan. Receives: Drug: RRx-001; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number, frequency and type of adverse events
Measured: 14 Weeks
Secondary outcomes (4)
Duration of clinical benefit rate
Duration of clinical benefit (Stable disease or better) using Response Evaluation Criteria in Solid Tumors [RECIST v1.1] criteria
Measured: 1 year
Progression-Free Survival
Progression-Free Survival (PFS) using Response Evaluation Criteria in Solid Tumors
Measured: 1 year
Overall Response rate
Proportion of patients with reduction in tumor burden using Response Evaluation Criteria in Solid Tumors
Measured: 1 year
Overall Survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start30 Aug 2016
- Primary completion22 Nov 2018
- Study completion9 Dec 2019
Why it stopped: Sufficient patients enrolled to end study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- EpicentRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bryan Oronsky, MD, Study director, EpicentRx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801097
- Sponsor's protocol ID
- RRx001-16-01
- Acronym
- PAYLOAD
- Status last verified
- May 2022
- First submitted
- 10 Jun 2016
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Multiple Ascending Dose Study to Assess the Safety and Tolerability of RRx-001 in Combination With Irinotecan in Metastatic or Advanced Cancer Patients Without Life-Prolonging Therapies of Demonstrated Clinical Benefit (PAYLOAD)
- ClinicalTrials.gov ID
- NCT02801097
- Acronym / sponsor ID
- PAYLOAD / RRx001-16-01
- Conditions
- Malignant Solid Tumor, Metastatic Cancer, Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sufficient patients enrolled to end study
- Enrolment
- 28 participants (actual)
- Lead sponsor
- EpicentRx, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2016 (actual)
- Primary completion
- 22 Nov 2018 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1 open-label trial to evaluate the safety, pharmacodynamics and clinical activity of RRx-001 administered in combination with irinotecan.
RRx-001 is associated with resensitization to irinotecan in tumors that are previously refractory. This effect has been attributed to the ability of RRx-001 to restore the expression of aberrantly silenced genes, thus re-establishing pathway functions. However, resensitization may have more than one mechanism, among them Pgp pump inhibition and vascular modulation, leading to improved penetration of standard chemotherapy.
Detailed description
This dose escalation study consists of 5 sequential dose cohorts each administered RRx-001 with irinotecan. After the first 3 subjects of each cohort complete Cycle 1, the safety will be assessed before moving to the next dose level. Subjects in the current cohort will continue treatment immediately following the completion of Cycle 1, for as long as therapy is tolerated and the RECIST v.1.1 definition of progression is not met.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RRx-001 + Irinotecan | Experimental | Drug: RRx-001, Drug: IrinotecanCohorts of participants with an advanced, malignant, solid tumor(s) will receive weekly doses of RRx-001 for 3 weeks, switching at week 4 to every-other-week treatments of RRx-001 with irinotecan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed diagnosis of an advanced, malignant, solid tumor(s) with all standard treatment options having been exhausted or declined.
- Eastern Cooperative Group (ECOG) performance status is 0-2 at Screening.
- Measurable disease per RECIST v1.1 by radiographic techniques
- Acceptable liver function, serum creatinine and hematological status
- Female subjects of childbearing potential, and male subjects with partners of childbearing potential, must agree to use medically acceptable methods of contraception beginning on Study Day 1 and continuing until at least four weeks after administration of the subject's final dose of RRx-001.
Key exclusion criteria (8 listed)
- Concurrent anticancer therapy; however, radiotherapy is allowed
- Any history of hypersensitivity to irinotecan
- Cholangitis that required treatment or intervention within 4 weeks of study enrollment
- Bilirubin > 2.0 mg/dL
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RRx-001 | Drug | RRx-001 + Irinotecan |
| Irinotecan | Drug | RRx-001 + Irinotecan |
Primary outcome
Number, frequency and type of adverse events
Time frame: 14 Weeks
4 secondary outcomes
Duration of clinical benefit rate
Time frame: 1 year
Progression-Free Survival
Time frame: 1 year
Overall Response rate
Time frame: 1 year
Overall Survival
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Sufficient patients enrolled to end study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Oronsky, MD study director
EpicentRx, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RRx-001 and Irinotecan in people with Malignant Solid Tumor and Metastatic Cancer, run by EpicentRx, Inc. at 2 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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was stopped early (reason given: Sufficient patients enrolled to end study). Results are not available in the source record.
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, frequency and type of adverse events (time frame: 14 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2022.