14 completed, 2 withdrawn, 1 available, 1 terminated. 11 Phase 2, 6 Phase 1, 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 11 | Completed 8, Withdrawn 2, Terminated 1 |
| Phase 1 | 6 | Completed 6 |
| Phase 3 | 3 | Completed 2, Unknown 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 |
|---|---|---|---|---|---|---|
| Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML Crenolanib, Cytarabine, Mitoxantrone - Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations | Phase 3 | Completed | Arog Pharmaceuticals, Inc. | 106 | 2018-08-16 | 2026-04-09 |
| Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML Crenolanib, Midostaurin, Cytarabine - Newly Diagnosed FLT3 Mutated AML | Phase 3 | Completed | Arog Pharmaceuticals, Inc. | 214 | 2018-08-15 | 2026-04-09 |
| A Study of Crenolanib With Fludarabine and Cytarabine in Pediatric Patients With Relapsed/Refractory FLT3-Mutated Acute Myeloid Leukemia Crenolanib, Fludarabine, Cytarabine - Relapsed/Refractory FLT3-mutated AML | Phase 2 | Withdrawn | Arog Pharmaceuticals, Inc. | 2018-01-01 | 2019-01-10 | |
| Study of Crenolanib With Ramucirumab and Paclitaxel for Advanced Esophagogastric Adenocarcinoma Crenolanib, Ramucirumab, Paclitaxel - Esophagogastric Adenocarcinoma | Phase 1 | Completed | Arog Pharmaceuticals, Inc. | 30 | 2017-04-14 | 2020-07-20 |
| Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST Crenolanib, Placebo - GIST With D842V Mutated PDGFRA Gene | Phase 3 | Unknown | Arog Pharmaceuticals, Inc. | 120 | 2016-08-01 | 2021-01-22 |
| Study of Crenolanib in Recurrent/Refractory Glioblastoma With PDGFRA Gene Amplification crenolanib - Recurrent/Refractory Glioblastoma | Phase 2 | Completed | Arog Pharmaceuticals, Inc. | 11 | 2016-04-01 | 2020-07-20 |
| Pilot Study of Crenolanib Combined With Standard Salvage Chemotherapy in Subjects With R/R AML Crenolanib, Mitoxantrone, Cytarabine - Relapsed/Refractory Acute Myeloid Leukemia (AML) | Phase 1 / Phase 2 | Completed | Arog Pharmaceuticals, Inc. | 16 | 2016-02-01 | 2023-12-20 |
| Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients Crenolanib besylate, Idarubicin, Cytarabine - Acute Myeloid Leukemia | Phase 1 / Phase 2 | Completed | Arog Pharmaceuticals, Inc. | 28 | 2015-09-01 | 2024-07-03 |
| Crenolanib Maintenance Following Allogeneic Stem Cell Transplantation in FLT3-positive Acute Myeloid Leukemia Patients Crenolanib besylate - Acute Myeloid Leukemia | Phase 2 | Completed | Arog Pharmaceuticals, Inc. | 30 | 2015-09-01 | 2023-12-18 |
| Crenolanib in Combination With Sorafenib in Patients With Refractory or Relapsed Hematologic Malignancies Crenolanib, Sorafenib, methotrexate, hydrocortisone and cytarabine with leucovorin - Acute Myeloid Leukemia | Phase 1 | Completed | St. Jude Children's Research Hospital | 10 | 2015-04-02 | 2017-10-03 |
| A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations crenolanib, cytarabine, daunorubicin - Newly Diagnosed AML With FLT3 Activating Mutations | Phase 2 | Completed | Arog Pharmaceuticals, Inc. | 44 | 2015-01-01 | 2024-02-02 |
| A Phase II Study of Crenolanib in Relapsed/Refractory Acute Myeloid Leukemia Patients With FLT3 Activating Mutations Crenolanib besylate - Acute Myeloid Leukemia With FLT3 Activating Mutations That Has Relapsed or Been Refractory After One or More Prior Therapies | Phase 2 | Completed | Arog Pharmaceuticals, Inc. | 56 | 2012-10-01 | 2023-11-30 |
| Phase II Study of Crenolanib in Subjects With Relapsed/Refractory AML With FLT3 Activating Mutations Crenolanib Besylate (CP-868,596-26) - Relapsed or Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations | Phase 2 | Completed | Arog Pharmaceuticals, Inc. | 14 | 2012-07-01 | 2024-01-30 |
| PDGFR Inhibitor Crenolanib in Children/Young Adults With Diffuse Intrinsic Pontine Glioma or Recurrent High-Grade Glioma Crenolanib - Diffuse Intrinsic Pontine Glioma, Progressive or Refractory High-Grade Glioma | Phase 1 | Completed | St. Jude Children's Research Hospital | 55 | 2011-07-01 | 2017-04-26 |
| Study of Crenolanib for the Treatment of Patients With Advanced GIST With the D842-related Mutations and Deletions in the PDGFRA Gene Crenolanib besylate (CP-868,596-26), Dose: 140mg BID - D842-related Mutant GIST | Phase 2 | Completed | Arog Pharmaceuticals, Inc. | 20 | 2011-04-01 | 2018-06-28 |
| Study of Crenolanib, a Selective and Potent Inhibitor of PDGFR, for the Treatment of Adult Gliomas Crenolanib (CP-868,596) - Glioma | Phase 2 | Terminated | Arog Pharmaceuticals, Inc. | 10 | 2011-04-01 | 2018-07-05 |
| A Phase 2 Study in Patients With Advanced Non-Small Cell Lung Cancer Using New Agents With and Without Docetaxel. docetaxel, CP-868,596 + docetaxel, AG-013736 + docetaxel - Carcinoma, Non-Small-Cell Lung | Phase 2 | Withdrawn | Arog Pharmaceuticals, Inc. | 2007-05-01 | 2012-08-09 | |
| CP-868,596 And CP-868,596 Plus AG-013736 In Combination With Docetaxel In Advanced Solid Tumors CP-868,596, Docetaxel, AG-013736 - Advanced Solid Tumors | Phase 1 | Completed | Arog Pharmaceuticals, Inc. | 50 | 2005-12-01 | 2012-01-19 |
| Individual Patient Compassionate Use of Crenolanib Crenolanib besylate - FLT3-ITD Mutation, FLT3/TKD Mutation | Available | Arog Pharmaceuticals, Inc. | 2024-08-09 |
Leukemia, Myeloid, Acute (4) · Recurrence (3) · Glioma (2) · Brain Neoplasms (1) · Carcinoma, Non-Small-Cell Lung (1) · Diffuse Intrinsic Pontine Glioma (1) · Gastrointestinal Stromal Tumors (1) · Glioblastoma (1) · Leukemia (1)
crenolanib (13) · Cytarabine (7) · Idarubicin (4) · fludarabine (4) · Granulocyte Colony-Stimulating Factor (3) · Mitoxantrone (3) · Axitinib (2) · Docetaxel (2) · Etoposide (2) · etoposide phosphate (2) · fludarabine phosphate (2) · Azacitidine (1) · BID protein, human (1) · Daunorubicin (1) · Hydrocortisone (1)
United States (16) · Italy (3) · France (2) · Germany (2) · Spain (2) · Australia (1) · Canada (1) · Norway (1) · Poland (1)
Jorge Cortes, MD (2) · Margaret von Mehren, MD (2) · Alberto Broniscer, MD (1) · Barbara O'Brien, MD (1) · Elizabeth Maher, M.D., Ph.D. (1) · Eunice Wang, MD (1) · Geoffrey Ku, MD (1) · Hiroto Inaba, MD, PhD (1) · Jean-Yves Blay, MD (1) · Michael C Heinrich, MD (1) · Richard Champlin, MD (1) · Richard Stone, MD (1)
PMID 24227820, PMID 35066693, PMID 38324741
2015 (1), 2017 (1)