Imetelstat Sodium
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Phase II
Active Not Recruiting
Study to Evaluate Imetelstat in Patients With High-Risk MDS or AML Failing HMA-based Therapy
Oct 13, 2022
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Ruxolitinib, Imetelstat Sodium, Pacritinib, Momelotinib, Fedratinib
Myelofibrosis
Phase I
Recruiting
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination With Ruxolitinib in Participants With Myelofibrosis
May 05, 2022
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Imetelstat Sodium
Myelodysplastic Syndromes
Phase II/III
Active Not Recruiting
Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Oct 27, 2015
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Imetelstat 4.7 Mg/Kg, Imetelstat 9.4 Mg/Kg
Myelofibrosis
Phase II
Completed
Study to Evaluate Activity of 2 Dose Levels of Imetelstat in Participants With Intermediate-2 or High-Risk Myelofibrosis (MF) Previously Treated With Janus Kinase (JAK) Inhibitor
Apr 21, 2015
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Imetelstat
Primary Myelofibrosis, Secondary Myelofibrosis, Myeloid Malignancies
Phase II
Completed
Imetelstat Sodium in Treating Participants With Primary or Secondary Myelofibrosis
Nov 18, 2012
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Bevacizumab, Paclitaxel, Imetelstat Sodium
Locally Recurrent Or Metastatic Breast Cancer
Phase II
Completed
Imetelstat in Combination With Paclitaxel (With or Without Bevacizumab) in Patients With Locally Recurrent or Metastatic Breast Cancer
Dec 02, 2010
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Imetelstat (7.5 Mg/Kg), Lenalidomide Standard Of Care, Imetelstat (9.4 Mg/Kg)
Multiple Myeloma
Phase II
Completed
Open Label Study With Imetelstat to Determine Effect of Imetelstat in Patients w/ Previously Treated Multiple Myeloma
Nov 16, 2010
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Imetelstat
Essential Thrombocythemia, Polycythemia Vera
Phase II
Completed
Open Label Study to Evaluate the Activity of Imetelstat in Patients With Essential Thrombocythemia or Polycythemia Vera
Nov 11, 2010
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Bevacizumab, Imetelstat
Non-small Cell Lung Cancer
Phase II
Completed
Imetelstat as Maintenance Therapy After Initial Induction Chemotherapy in Non-small Cell Lung Cancer (NSCLC)
Jun 03, 2010
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Geron Corp (GON) have in its pipeline
GON is currently developing the following drugs: Imetelstat Sodium, Ruxolitinib, Imetelstat Sodium, Pacritinib, Momelotinib, Fedratinib, Imetelstat, Best Available Therapy (BAT). These drug candidates are in various stages of clinical development as the company works toward FDA approval.