RRx-001-33: REPLATINUM: 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

About this Study

The purpose of this study is to look at an experimental drug that boosts the body's natural defenses to fight cancer to see if it has the potential to reduce or prevent tumors.

Sponsor Protocol ID:RRx001-33
IRB Number:2018-0228
Actively Enrolling
Interventional
Phase 3
July 31, 2019
Eligibility Criteria
18 years old
100 years old
Both Male and Female
Yes
No
Yes

Inclusion Criteria
1. Age ≥ 18 years male or female (in certain territories, the minimum age requirement
may be higher e.g., age > 20 years in Japan and Taiwan, age > 21 years in Singapore)
AND

2. Prior platinum treatment is required

4. Capable of providing informed consent and complying with trial procedures

5. If feasible and clinically indicated, must have received vaccinations for influenza, pneumococci, H. influenzae type B and Hepatitis B at least 2 weeks before starting
therapy

7. Life expectancy of ≥ 12 weeks

10. Prior chemoembolization, radiofrequency ablation, or radiation is allowed as long as the patient has measurable disease and the lesion(s) that is being measured is 1) at least
12 weeks out from palliative therapy and 2) exhibits increased measurable growth

13. Accessibility to the site that ensures the patient will be able to keep all study-related appointments

14. Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control;
abstinence) prior to study entry, for the duration of study participation, and for 90 days
following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Note: A woman of child-bearing potential is any female (regardless of sexual
orientation, having undergone a tubal ligation, or remaining celibate by choice) who
meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months
(i.e., has had menses at any time in the preceding 12 consecutive months)

Exclusion Criteria
1. Symptomatic central nervous system metastases or neurologically unstable patients that are on increasing steroid dose.

2. Life expectancy

3. 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

Categories Click category to view its trials.
Cancer
Participating Locations
Cancer Center and Research Institute
University Hospital
Contact Information
Contact Name: Jennifer Barnes
Phone Number: 601-815-4540
Email: jbarnes@umc.edu
Principal Investigator:Ruckdeschel, John C, M.D.
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