RRx-001 in Combination With Irinotecan in Metastatic or A... | NCT02801097

Studies
RRx-001 in Combination With Irinotecan in Metastatic or Advanced Cancer (PAYLOAD)

NCT02801097

Sponsor

EpicentRx, Inc.

Status

Terminated

Last Update Posted

May 17, 2022Actual

Enrollment

28Actual

Phase

Phase 1

Conditions

Malignant Solid Tumor
Metastatic Cancer
Advanced Cancer

Interventions

RRx-001
Irinotecan

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sufficient patients enrolled to end study

Expanded Access Info

Start Date

Aug 30, 2016Actual

Primary Completion Date

Nov 22, 2018Actual

Completion Date

Dec 9, 2019Actual

First Submitted Date

Jun 10, 2016

First Submission Date that Met QC Criteria

Jun 10, 2016

First Posted Date

Jun 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2022

Last Update Posted Date

May 17, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Drug: RRx-001 Drug: Irinotecan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RRx-001	Drug		RRx-001 + Irinotecan
Irinotecan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number, frequency and type of adverse events		14 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Duration of clinical benefit rate	Duration of clinical benefit (Stable disease or better) using Response Evaluation Criteria in Solid Tumors [RECIST v1.1] criteria	1 year
Progression-Free Survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bryan Oronsky, MD	EpicentRx, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, Davis		Sacramento	California	95817	United States
Rutgers Cancer Institute of New Jersey

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds