Genasense® (oblimersen sodium) Injection has been studied with Most Types of Anticancer Therapies. Multiple preclinical studies have shown that Genasense® synergizes with most types of anticancer treatment, including chemotherapy, radiation, monoclonal antibodies and immunotherapy. Based on preclinical data, Genta has conducted, or is currently conducting, preliminary clinical trials using Genasense® in combination with:
Novel Combinations with Multiple Agents in Multiple Tumor Types
Genasense® (oblimersen sodium) Injection has been in clinical trials since 1995 in the U.S., Europe and Australia, with efficacy and safety data from Phase 1, Phase 2 and Phase 3 clinical trials. More than 2,200 patients have entered randomized trials (one-half of whom were controls) and approximately 500 patients have been treated in non-randomized Phase 2 trials sponsored by Genta, through a long-standing Cooperative Research and Development Agreement (CRADA) with the U.S. National Cancer Institute (NCI), or the European Organization for the Research and Treatment of Cancer (EORTC).
In its initial trial, Genta performed the largest randomized controlled trial that has ever been conducted in patients with advanced melanoma. The melanoma trial was a front-line trial conducted in patients who had not previously received systemic chemotherapy (prior immunotherapy was allowed.) A total of 771 patients were randomized to receive Genasense® (oblimersen sodium) Injection plus dacarbazine (DTIC) or dacarbazine alone. The primary end-point of the study was overall survival; secondary end-points included overall response and progression-free survival (PFS).
The AGENDA Trial is the second randomized Phase 3 trial in advanced melanoma for Genasense®. The trial is designed to expand evidence for the safety and efficacy of Genasense® combined with dacarbazine for patients who have not previously been treated with chemotherapy. The study will prospectively target patients using a biomarker that identified patients who derived maximal benefit in a preceding trial of Genasense®, including significant increases in overall and progression-free survival. Genta expects to enroll approximately 300 subjects in this trial. More on the AGENDA trial...
Completed Clinical Trials
GM301 Genasense® with or without DTIC in previously untreated advanced melanoma
Genasense® plus DTIC was compared to DTIC alone in this - the largest randomized multi-national study to date - in 771 patients with previously untreated advanced melanoma.
The AGENDA Trial (GM307) A Randomized Controlled Trial of Genasense® Plus Dacarbazine (DTIC) Compared with Darcarbizine Alone in Patients with Previously Untreated Advanced Melanoma
AGENDA is a 300 patient randomized trial designed to expand evidence for the safety and efficacy of Genasense® combined with darcarbizine (DTIC) for patients who have not previously been treated with chemotherapy.
Genta is actively recruiting experienced investigative sites in Europe, Australia, and North America. The study seeks to confirm the benefit observed in the original phase 3 trial and will target patients using the biomarker (serum lactate dehydrogenase [LDH]). AGENDA Study Design
For more information on the Genta clinical development program please contact us at
or 1-888-To-Genta (1-888-864-3682) or at clinicaltrials.gov at the following link:
TAG Trial - Genasense® + Abraxane + Temodar in previously untreated advanced melanoma
Based on preclinical results that demonstrated marked anticancer synergy when Genasense® (oblimersen sodium) Injection was combined with Abraxane (paclitaxel protein-bound particles: Abraxis Oncology, Inc.) and Temodar (temozolomide: Schering Plough , Inc.), this study will evaluate the safety, efficacy, pharmacokinetics and pharmcodynamics of the three-drug combination in chemotherapy-naïve patients whom have normal levels of serum lactate dehydrogenase (LDH).
The initial randomized CLL trial was conducted in relapsed/refractory patients. Patients were eligible if they had failed standard treatment for CLL that had included fludarabine. A total of 241 patients were randomized to receive chemotherapy with fludarabine and cyclophosphamide with or without Genasense®. The primary objective of the study was to evaluate whether the addition of Genasense® would increase the proportion of patients who achieved complete remission (CR) or nodular partial remission (nPR). Secondary end-points included comparisons of complete remission, remission duration, time-to-progression, and overall survival.
Completed Clinical Trials
GL303 Genasense® plus Flu/Cy in relapsed or refractor CLL
In this multinational trial involving 241 patients with relapsed or refractory chronic lymphocytic leukemnia (CLL) – the first randomized trial ever conducted in this population, Genasense® plus standard chemotherapy (fludarabine plus cyclophosphamide – Flu/Cy) was compared with Flu/Cy alone.
GL217 Phase 2 Trial of G-FR in Relapse/Refractory Chronic Lymphocytic Leukemia
This trial is investigated the safety and efficacy of a combination regimen containing Genasense®, fludarabine and rituximab in patients with chronic lymphocytic leukemia who were previously treated for their disease.
For more information on the Genta clinical development program please contact us at
or 1-888-To-Genta (1-888-864-3682).
Phase II study to determine the efficacy and toxicity of Genasense® (oblimersen sodium) Injection plus rituximab in patients with recurrent B-cell NHL.
Active Trials
PROPOSED Phase II Study of Genasense® plus R-CHOP in patients with previously untreated B-cell Non-Hodkin's Lymphoma
For more information on the Genta clinical development program please contact us at
or 1-888-To-Genta (1-888-864-3682).
Genasense® (oblimersen sodium) Injection – OTHER TRIALS
Active Trials
GPK103: A Pharmacokinetic Study of Genasense® (Bcl-2 Antisense Oligonucleotide) in Combination with Dacarbazine (DTIC) in Patients with Hepatic Impairment and Advanced Malignant Melanoma
GP104: A Phase 1 Pharmacokinetic Study of Genasense® in Patients with Normal Renal Function and Mildly and Moderately Impaired Renal Function
GP105: A Randomized, Open-label, Cross-over Pharmacokinetic Study of Dacarbazine in combination with Genasense® in Patients with Advanced Melanoma
GPK109 A Safety, Pharmacokinetic, and Pharmacodynamic Assessment of Genasense® Administered as a 2-hour Intravenous Infusion to Subjects with Solid Tumors Information on these trials can be obtained at www.ClinicalTrials.gov.
Clinical results have demonstrated that Genasense® (oblimersen sodium) Injection can be safely administered by intermittent subcutaneous (SC) injection, as well as by short intravenous (IV) infusion. These regimens may eventually reduce or eliminate the current requirements for administering Genasense® by continuous IV (CIV) infusion. The new schedules also expand the potential for use in combination with anticancer drugs that are administered on a daily or weekly basis and form the basis for clinical development of Genasense® as monotherapy.
The SC study used a new formulation of Genasense® (oblimersen sodium) Injection that was concentrated 5- fold greater than that used in previous Phase 3 trials. In a dose-ranging pharmacokinetic (PK) and pharmacodynamic trial, bolus SC injections of 75, 150 and 225 mg yielded dose-proportional plasma concentrations that were associated with down-regulation of Bcl-2 in blood cells. The 225 mg dose level achieved exposure PK parameters that were similar to levels achieved at the 3 mg/kg CIV daily dose level that was tested in the recent Phase 3 trial of Genasense® in chronic lymphocytic leukemia (CLL).
SC Pharmacokinetics
SC AUC
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A second phase of the program is testing escalating doses of Genasense® (oblimersen sodium) Injection administered as a 2-hour IV infusion. Single 150 mg doses, as well as repeated 150 mg doses administered daily for 5 consecutive days, have been well-tolerated. To date, the principal adverse events have been reversible skin reactions at the injection site on the SC schedule and transient fever on the brief IV schedule.
Completed Trials
GPKS106 A Pharmacokinetic and Safety Assessment of G3139 (150 mg/mL) Administered by Subcutaneous Injection and Genasense® ([G3139] 30 mg/mL) Injection Administered by Short Intravenous Infusion to Patients with Solid Tumors
Active Trials
GPK109 A Safety, Pharmacokinetic, and Pharmacodynamic Assessment of Genasense® Administered as a 2-hour Intravenous Infusion to Subjects with Solid Tumors
For more information on the Genta clinical development program please contact us at
or 1-888-To-Genta (1-888-864-3682).
Clinical Development 
