17 completed, 3 terminated, 1 unknown. 21 Phase 1, 9 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 21 | Completed 17, Terminated 3, Unknown 1 |
| Phase 2 | 9 | Completed 7, Terminated 2 |
Follow oblimersen: new trials by email Literature Review of oblimersen trials Research Report on oblimersen
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 |
|---|---|---|---|---|---|---|
| Genasense as a 2-hour Intravenous Infusion in Subjects With Solid Tumors Oblimersen (Genasense) - Solid Tumors | Phase 1 | Completed | Genta Incorporated | 25 | 2007-05-01 | 2012-04-06 |
| Abraxane and Temodar Plus Genasense in Advanced Melanoma Genasense® (oblimersen), Abraxane® (paclitaxel protein-bound particles for injectable suspension), Temodar® (temozolomide) - Melanoma | Phase 1 | Unknown | Genta Incorporated | 28 | 2006-11-01 | 2011-11-07 |
| Pharmacokinetic Study of Genasense in Subjects With Normal Renal Function, Mildly Impaired Renal Function, and Moderately Impaired Renal Function Genasense (oblimersen, G3139) - Normal Renal Function, Mildly Impaired Renal Function | Phase 1 | Completed | Genta Incorporated | 23 | 2006-05-01 | 2012-03-13 |
| A Phase I, Randomized, Open-label, Cross-over, Pharmacokinetic Study of Genasense With and Without Dacarbazine Genasense® (G3139, oblimersen sodium), Genasense followed by DTIC; then DTIC alone, DTIC alone; then Genasense followed by DTIC - Advanced Melanoma | Phase 1 | Completed | Genta Incorporated | 2006-04-01 | 2012-03-13 | |
| A Phase I Study of G3139 Subcutaneous in Solid Tumors G3139, Oblimersen sodium, Bcl-2 antisense oligonucleotide - Tumors | Phase 1 | Completed | Genta Incorporated | 8 | 2005-12-01 | 2007-10-12 |
| Oblimersen, Rituximab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma oblimersen sodium, rituximab, ifosfamide - Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Grade 3 Follicular Lymphoma | Phase 1 / Phase 2 | Completed | National Cancer Institute (NCI) | 25 | 2004-05-01 | 2013-01-24 |
| Oblimersen, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma oblimersen sodium, rituximab, cyclophosphamide - Lymphoma | Phase 1 | Completed | British Columbia Cancer Agency | 2003-07-01 | 2009-04-07 | |
| A Phase I/II Study of Oblimersen Plus Cisplatin and Fluorouracil in Gastric & Esophageal Junction Cancer oblimersen sodium, cisplatin, fluorouracil - Adenocarcinoma of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction | Phase 1 / Phase 2 | Terminated | National Cancer Institute (NCI) | 15 | 2003-06-01 | 2021-02-17 |
| Oblimersen Plus Doxorubicin and Docetaxel in Treating Patients With Metastatic or Locally Advanced Breast Cancer oblimersen sodium, doxorubicin hydrochloride, docetaxel - Male Breast Cancer, Stage IIIA Breast Cancer | Phase 1 / Phase 2 | Terminated | National Cancer Institute (NCI) | 31 | 2003-05-01 | 2019-03-05 |
| Oblimersen in Treating Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia oblimersen sodium - Waldenström Macroglobulinemia | Phase 1 / Phase 2 | Completed | National Cancer Institute (NCI) | 58 | 2003-05-01 | 2013-06-04 |
| Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma oblimersen sodium, gemcitabine hydrochloride, pharmacological study - Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma | Phase 1 | Terminated | National Cancer Institute (NCI) | 15 | 2003-03-01 | 2013-01-25 |
| Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors oblimersen sodium, dexrazoxane hydrochloride, doxorubicin hydrochloride - Cardiac Toxicity, Unspecified Childhood Solid Tumor, Protocol Specific | Phase 1 | Completed | National Cancer Institute (NCI) | 15 | 2002-11-01 | 2013-01-17 |
| Combination Chemotherapy Plus Oblimersen in Treating Patients With Advanced Solid Tumors oblimersen sodium, paclitaxel, laboratory biomarker analysis - Unspecified Adult Solid Tumor, Protocol Specific | Phase 1 | Completed | National Cancer Institute (NCI) | 55 | 2002-10-01 | 2013-05-16 |
| Combination Chemotherapy and Oblimersen in Treating Patients With Advanced Colorectal Cancer oblimersen sodium, fluorouracil, leucovorin calcium - Colorectal Cancer | Phase 1 / Phase 2 | Completed | The University of Texas Health Science Center at San Antonio | 16 | 2002-10-01 | 2012-07-04 |
| Oblimersen, Cytarabine, and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia oblimersen sodium, cytarabine, daunorubicin hydrochloride - Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) | Phase 1 | Completed | National Cancer Institute (NCI) | 32 | 2002-04-01 | 2015-12-04 |
| Combination Chemotherapy Plus Oblimersen in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer oblimersen sodium, carboplatin, etoposide - Extensive Stage Small Cell Lung Cancer | Phase 1 | Completed | National Cancer Institute (NCI) | 12 | 2001-04-01 | 2013-01-24 |
| Phase I/II Study of Genasense in Patients With Chronic Lymphocytic Leukemia Oblimerson sodium, G3139 - Chronic Lymphocytic Leukemia, CLL | Phase 1 / Phase 2 | Completed | Genta Incorporated | 40 | 2001-01-01 | 2009-11-13 |
| Olimersen and Irinotecan in Treating Patients With Metastatic or Recurrent Colorectal Cancer oblimersen sodium, irinotecan hydrochloride - Colorectal Cancer | Phase 1 / Phase 2 | Completed | The University of Texas Health Science Center at San Antonio | 2000-06-01 | 2013-02-21 | |
| Bcl-2 Antisense Oligodeoxynucleotide G3139 and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer oblimersen sodium, paclitaxel - Lung Cancer | Phase 1 / Phase 2 | Completed | University of Chicago | 12 | 2000-04-01 | 2013-02-11 |
| Augmerosen Plus Fludarabine and Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia filgrastim, oblimersen sodium, cytarabine - Leukemia | Phase 1 | Completed | National Cancer Institute (NCI) | 24 | 1999-10-01 | 2013-02-01 |
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Colonic Neoplasms (3) · Colorectal Neoplasms (3) · Lymphoma, Large B-Cell, Diffuse (3) · Rectal Neoplasms (3) · Breast Neoplasms (2) · Esophageal Neoplasms (2) · Leukemia (2) · Leukemia, Lymphocytic, Chronic, B-Cell (2) · Lung Neoplasms (2) · Lymphoma, Follicular (2) · Lymphoma, Mantle-Cell (2) · Neoplasms (2) · Precursor Cell Lymphoblastic Leukemia-Lymphoma (2) · Adenocarcinoma Of Esophagus (1) · Breast Neoplasms, Male (1)
National Cancer Institute (NCI) (10) · Genta Incorporated (6) · The University of Texas Health Science Center at San Antonio (2) · British Columbia Cancer Agency (1) · Memorial Sloan Kettering Cancer Center (1) · University of Chicago (1)
United States (20) · Canada (1)
Anthony W. Tolcher, MD (2) · Andreas Kaubisch (1) · Anna C Pavlick, MD (1) · Charles M. Rudin, MD, PhD (1) · Charles Rudin (1) · Francisco Esteva (1) · George Wilding (1) · Guido Marcucci (1) · Guido Marcucci, MD (1) · Harry Alcorn, PharmD (1) · Michael Morris, MD (1) · Morie Gertz (1) · Richard J. Klasa, MD (1) · Sonali Smith (1)
PMID 12056703, PMID 16186597, PMID 19738454
N01CM17003 (1), N01CM17102 (1), N01CM17104 (1), N01CM62201 (1), N01CM62204 (1), P30CA016672 (1), P30CA054174 (1), U01CA062491 (1), U01CA069853 (1), U01CA076576 (1), U01CA097452 (1)