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Trial record 4 of 11 for:    rrx-001

RRx-001 Prior to a Platinum Doublet or a Platinum Doublet Alone in Patients With Small Cell Carcinoma (REPLATINUM)

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ClinicalTrials.gov Identifier: NCT03699956
Recruitment Status : Not yet recruiting
First Posted : October 9, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
EpicentRx, Inc.

Brief Summary:
The purpose of this study is to find out more about the experimental drug called RRx-001, which is a form of immunotherapy called a checkpoint inhibitor, that is also thought to reduce resistance to chemotherapy. This study is for patients with Small Cell Carcinoma (SCC), a tumor type that usually occurs in the lungs but sometimes also outside of the lungs. This study will compare the impact of the addition of the study drug, RRx-001, to "platinum doublet" chemotherapy versus platinum doublet chemotherapy alone. The combination of cisplatin or carboplatin with another chemotherapy agent is called a "platinum doublet". In this study, cisplatin or carboplatin will be combined with etoposide, which is an approved treatment for small cell cancer.

Condition or disease Intervention/treatment Phase
Carcinoma, Small Cell Carcinoma, Small Cell Lung Combination Product: RRx-001 + eLOOP Device Drug: Cisplatin/carboplatin plus etoposide Phase 3

Detailed Description:

In this study, patients will be randomized to 1 of 2 groups or arms. The verb "to randomize" means to put into a group by chance. The selection of patient groups or arms is made or determined randomly by a computer program (hence the word randomize). The treatments in this study are not blinded, meaning patients and the study doctor will know what treatments the patient will receive.

Patients in Arm 1 will receive the study drug, RRx-001, once a week for 3 weeks followed by up to 4 cycles of platinum doublet (platinum plus etoposide) chemotherapy. Patients who have stable disease or better following their chemotherapy may go on to receive RRx-001 again (this time for 2 weeks) followed by 2 cycles of chemotherapy. These patients will continue to receive RRx-001 once a week for 2 weeks followed by 2 cycles of single agent platinum chemotherapy in a repeating pattern until such time as their cancer gets worse. Single agent platinum chemotherapy means that patients will only receive the platinum agent, cisplatin or carboplatin, without etoposide.

Patients in Arm 2 will receive the standard of care platinum doublet (platinum plus etoposide) chemotherapy for up to 4 cycles. Patients in arm 2 whose cancer gets worse (as determined by imaging scans), may "cross-over" to the Platinum Stacking Phase of Arm 1. If this occurs, patients will receive RRx-001 once a week for 2 weeks followed by 2 cycles of single agent platinum chemotherapy in a repeating pattern until such time as their cancer gets worse.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: In this study, patients will be randomized to 1 of 2 groups or arms. Patients in Arm 1 will receive the study drug, RRx-001, once a week for 3 weeks followed by up to 4 cycles of platinum doublet (platinum plus etoposide) chemotherapy. Patients in Arm 2 will receive the standard of care platinum doublet (platinum plus etoposide) chemotherapy for up to 4 cycles. . Patients in arm 2 whose cancer gets worse (as determined by imaging scans), may "cross-over" to the Platinum Stacking Phase of Arm 1 (see study schema below). If this occurs, patients will receive RRx-001 once a week for 2 weeks followed by 2 cycles of single agent platinum chemotherapy in a repeating pattern until such time as their cancer gets worse.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Controlled, Open-label, Randomized Study of RRx-001 Administered Sequentially With a Platinum Doublet or a Platinum Doublet in Third-Line or Beyond Small Cell Carcinoma
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1

RRx-001 + eLOOP Device 4 mg IV infusion once weekly for 3 weeks

Cisplatin/carboplatin plus etoposide (up to 4 cycles):

  1. Cisplatin or Carboplatin:

    1. Cisplatin initially dosed at 60 mg/m2 on Day 1 every 3 weeks OR
    2. Carboplatin initially dosed at an AUC (area under the curve) of 5 on Day 1 every 3 weeks
  2. Etoposide to be given per the initial approval by the package insert (USPI FDA) at 100 mg/m2 Days 1-3 every 3 weeks
Combination Product: RRx-001 + eLOOP Device
RRx-001 is a small molecule anticancer drug which is mixed with patient's own blood using the eLOOP device

Drug: Cisplatin/carboplatin plus etoposide
Standard of care platinum doublet chemotherapy

Active Comparator: Arm 2

Cisplatin/carboplatin plus etoposide (up to 4 cycles):

  1. Cisplatin or Carboplatin:

    1. Cisplatin initially dosed at 60 mg/m2 on Day 1 every 3 weeks OR
    2. Carboplatin initially dosed at an AUC of 5 on Day 1 every 3 weeks
  2. Etoposide to be given per the initial approval by the package insert (USPI FDA) at 100 mg/m2 Days 1-3 every 3 weeks
Drug: Cisplatin/carboplatin plus etoposide
Standard of care platinum doublet chemotherapy




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Estimated up to 12 Months ]
    The time from the date of randomization to disease progression (radiologic and/or symptomatic per RECIST 1.1) or death from any cause


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Estimated up to 12 Months ]
    The time from randomization to death from any cause

  2. Overall response rate [ Time Frame: Estimated up to 12 Months ]
    The proportion of patients with a complete response or a partial response (per RECIST 1.1)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 and < 80 years
  2. Prior platinum treatment is required
  3. Biopsy confirmation of small cell carcinoma from any primary
  4. Capable of providing informed consent and complying with trial procedures
  5. Measurable disease by RECIST 1.1. Measurable lesions will be confirmed by imaging (CT scan)

Exclusion Criteria:

  1. Symptomatic central nervous system metastases or neurologically unstable patients that are on increasing steroid dose.
  2. Patients with clinically significant illnesses which would compromise participation in the study, including, but not limited to active or uncontrolled infection, immune deficiencies, Hepatitis B, Hepatitis C, uncontrolled diabetes, uncontrolled hypertension, certain heart conditions, or mental illness/social situations that would limit compliance with study requirements.
  3. History of an allergic reaction to previously received platinum-based regimen, or history of having to discontinue previously received platinum-based regimen secondary to toxicity
  4. Any clinical laboratory findings, which give reasonable suspicion of a disease or condition that contraindicates the use of any study medication or renders the patient at high risk from treatment
  5. Uncontrolled or symptomatic pleural or pericardial effusion
  6. Pregnant or nursing. There is a potential for congenital abnormalities and for this regimen to harm nursing infants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699956


Contacts
Contact: Mary Quinn, MS, CRNP 858-947-6649 mquinn@epicentrx.com
Contact: Scott Caroen scaroen@epicentrx.com

Sponsors and Collaborators
EpicentRx, Inc.
Investigators
Study Director: Bryan Oronsky, MD, PhD EpicentRx, Inc.

Responsible Party: EpicentRx, Inc.
ClinicalTrials.gov Identifier: NCT03699956     History of Changes
Other Study ID Numbers: RRx001-33
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by EpicentRx, Inc.:
RRx-001
Lung Cancer
Small Cell
Lung Neoplasms
Phase 3
Immunotherapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Etoposide phosphate
Cisplatin
Carboplatin
Etoposide
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action