7 completed, 5 terminated, 3 active not recruiting, 1 no longer available. 7 Phase 1, 6 Phase 2, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 7 | Completed 4, Terminated 3 |
| Phase 2 | 6 | Completed 3, Active not recruiting 2, Terminated 1 |
| Phase 3 | 2 | Active not recruiting 1, Terminated 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer RRx-001, Intensity Modulated Radiation Therapy (IMRT), Cisplatin for injection 100 mg/m2 - Oral Mucositis | Phase 2 | Active not recruiting | EpicentRx, Inc. | 216 | 2024-04-02 | 2026-06-26 |
| RRx-001 Given With Irinotecan and Temozolomide for Pediatric Patients With Recurrent or Progressive Malignant Solid and Central Nervous System Tumors RRx-001, Temozolomide, Irinotecan - Brain Tumor, Recurrent, Brain Tumor, Pediatric | Phase 1 | Terminated | EpicentRx, Inc. | 2 | 2023-01-26 | 2024-10-31 |
| A Phase 3, Controlled, Open-label, Global Randomized Study of RRx-001 With a Platinum Doublet or a Platinum Doublet in Small Cell Lung Cancer RRx-001 + eLOOP Device, Cisplatin/carboplatin plus etoposide - Carcinoma, Small Cell Lung | Phase 3 | Active not recruiting | EpicentRx, Inc. | 292 | 2022-08-01 | 2024-10-31 |
| A Study of AdAPT-001 in Subjects With Sarcoma and Refractory Solid Tumors AdAPT-001, Checkpoint Inhibitor, Immune - Solid Tumor, Adult, Cancer | Phase 2 | Active not recruiting | EpicentRx, Inc. | 140 | 2021-03-29 | 2026-06-26 |
| RRx-001 Sequentially With a Platinum Doublet or a Platinum Doublet in Third-Line or Beyond in Patients With Small Cell Lung Cancer RRx-001 + eLOOP Device, Cisplatin/carboplatin plus etoposide - Carcinoma, Small Cell Lung | Phase 3 | Terminated | EpicentRx, Inc. | 18 | 2018-12-24 | 2024-03-26 |
| Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers RRx-001, Cisplatin for injection, Radiation Therapy - Oral Mucositis | Phase 2 | Completed | EpicentRx, Inc. | 53 | 2018-07-12 | 2024-11-04 |
| RRx-001 + Radiation + Temozolomide In Newly Diagnosed Glioblastoma and Anaplastic Gliomas RRx-001 dose escalation with TMZ + RT, Radiation, Fixed dose Temozolomide (75 mg/m2) - Glioblastoma, Oligodendroglioma | Phase 1 | Completed | EpicentRx, Inc. | 19 | 2017-02-14 | 2022-05-16 |
| RRx-001 in Combination With Irinotecan in Metastatic or Advanced Cancer (PAYLOAD) RRx-001, Irinotecan - Malignant Solid Tumor, Metastatic Cancer | Phase 1 | Terminated | EpicentRx, Inc. | 28 | 2016-08-30 | 2022-05-17 |
| A Phase I, Open-Label, Multiple Ascending Dose Study of RRx-001 and Nivolumab RRx-001, Nivolumab - Malignant Solid Tumor, Lymphoma | Phase 1 | Completed | EpicentRx, Inc. | 12 | 2015-07-21 | 2019-11-18 |
| RRx-001 in Second Line Treatment of Advanced Cholangiocarcinoma Prior to Readministration of First-Line Therapy RRx-001, Gemcitabine and cisplatin - Cholangiocarcinoma | Phase 2 | Terminated | EpicentRx, Inc. | 4 | 2015-07-16 | 2024-04-24 |
| RRx-001 in Lung Cancer, Ovarian Cancer and Neuroendocrine Tumors Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT) RRx-001, Cisplatin, Etoposide - Small Cell Carcinoma, Carcinoma, Non-Small-Cell Lung | Phase 2 | Completed | EpicentRx, Inc. | 139 | 2015-06-01 | 2025-03-17 |
| Dose-Escalation Study of RRx-001 in Combination With Whole Brain Radiation in Subjects With Brain Metastases RRx-001 + WBRT - Brain Metastases | Phase 1 | Completed | EpicentRx, Inc. | 29 | 2015-02-06 | 2021-11-03 |
| A Phase 2 Randomized, Open-Label Study of RRx-001 vs Regorafenib in Subjects With Metastatic Colorectal Cancer RRx-001, Regorafenib, Irinotecan - Colorectal Neoplasms | Phase 2 | Completed | EpicentRx, Inc. | 62 | 2014-05-01 | 2024-10-15 |
| A Phase 1 Pilot Study of the Subcutaneous (s.c.) Route to Facilitate the Administration of RRx-001 RRx-001 - Malignant Solid Tumor, Lymphomas | Phase 1 | Terminated | EpicentRx, Inc. | 2 | 2014-04-01 | 2016-01-21 |
| Safety and Pharmacokinetic Study of RRx-001 in Cancer Subjects RRx-001 - Malignant Solid Tumor, Lymphomas | Phase 1 | Completed | EpicentRx, Inc. | 26 | 2011-09-01 | 2024-11-01 |
| Expanded Access for PSV Personalized Oncolytic Viruses PSV - Cancer | No longer available | EpicentRx, Inc. | 2019-03-06 |
Neoplasms (4) · Lymphoma (3) · Brain Neoplasms (2) · Carcinoma, Small Cell (2) · Head and Neck Neoplasms (2) · Lung Neoplasms (2) · Mouth Neoplasms (2) · Mucositis (2) · Small Cell Lung Carcinoma (2) · Stomatitis (2) · Adenoviridae Infections (1) · Carcinoma, Non-Small-Cell Lung (1) · Carcinoma, Ovarian Epithelial (1) · Carcinoma, Squamous Cell (1) · Central Nervous System Neoplasms (1)
RRx-001 (13) · Cisplatin (6) · Irinotecan (4) · Carboplatin (3) · Etoposide (3) · Gemcitabine (2) · Injections (2) · Temozolomide (2) · 130-nm albumin-bound paclitaxel (1) · Bevacizumab (1) · Immune Checkpoint Inhibitors (1) · Nivolumab (1) · Paclitaxel (1) · Pemetrexed (1) · Radiation (1)
United States (15)
Bryan Oronsky, MD (4) · Bryan Oronsky, MD, PhD (3) · Jeffrey Infante, MD (2) · Ana De Jesus Acosta, MD (1) · Bryan Oronsky (1) · Bryan Oronsky, MD PhD (1) · John Morris, MD (1) · Meaghan Stirn (1) · Michelle Kim, MD (1) · Stephanie Fetzko, MD (1) · Tony Reid, MD (1)
PMID 24575021, PMID 26296952, PMID 31231122, PMID 31509028, PMID 33569311, PMID 35950603, PMID 36529613, PMID 36920652, PMID 36960054, PMID 39461878