drugset / Trial / NCT02489903
RRx-001 in Lung Cancer, Ovarian Cancer and Neuroendocrine Tumors Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT)
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is designed to explore the potential of the epigenetic agent RRx-001 to sensitize patients who previously received and now have failed a platinum based doublet regimen. RRx-001 is administered with autologous blood once weekly followed by or in combination with reintroduction of platinum-based doublet therapy.
Timeline
- Start
- 2015-06
- Primary completion
- 2021-12-06
- Completion
- 2021-12-06
Outcome
Met primary endpoint
release “QUADRUPLE THREAT clinical trial (NCT02489903) of RRx-001 in late line SCLC patients, which achieved its primary endpoint” epicentrx.com ↗
Publications
- Tomita Y, Oronsky B, Abrouk N, Cabrales P, Reid TR, Lee MJ, Yuno A, Baker J, Lee S, Trepel JB. In small cell lung cancer patients treated with RRx-001, a downregulator of CD47, decreased expression of PD-L1 on circulating tumor cells significantly correlates with clinical benefit. Transl Lung Cancer Res. 2021 Jan;10(1):274-278. doi: 10.21037/tlcr-20-359.
- Morgensztern D, Rose M, Waqar SN, Morris J, Ma PC, Reid T, Brzezniak CE, Zeman KG, Padmanabhan A, Hirth J, I Spira A, Trepel JB, Padda SK. RRx-001 followed by platinum plus etoposide in patients with previously treated small-cell lung cancer. Br J Cancer. 2019 Jul;121(3):211-217. doi: 10.1038/s41416-019-0504-8. Epub 2019 Jun 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | Intravenous |
| Subject | Cisplatin | Other / unclassified | 60 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 80 mg/m2 | Intravenous |
| Comparator | Doxorubicin | Other / unclassified | — | — |
| Subject | Etoposide | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | — | — |
| Comparator | Irinotecan | Small molecule | — | — |
| Subject | NIBROZETONE | Other / unclassified | 4 mg | Intravenous |
| Subject | Nab-paclitaxel | Small molecule | — | — |
| Subject | Paclitaxel | Small molecule | — | — |
| Subject | Pemetrexed | Small molecule | — | — |
| Comparator | Vinorelbine | Small molecule | — | — |