Multiple Phase I and Phase II clinical trials have evaluated geldanamycin derivatives across various malignancies, including adult and pediatric solid tumors, non-Hodgkin lymphoma, prostate cancer, melanoma, renal cell carcinoma, and leukemias. Focused on pharmacokinetic safety, dose escalation, and preliminary efficacy, these studies have overall recruitment statuses listed as completed or terminated. Prominent sponsors driving this research include the National Cancer Institute, Cancer Research UK, Memorial Sloan Kettering Cancer Center, and Biogen.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT00019708 | TERMINATED | Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Nodal Marginal Zone B-cell Lymphoma; Non-Hodgkin Lymphoma; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Small Lymphocytic Lymphoma; Splenic Marginal Zone Lymphoma; Stage IV Adult Burkitt Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma; Stage IV Adult Diffuse Mixed Cell Lymphoma; Stage IV Adult Diffuse Small Cleaved Cell Lymphoma; Stage IV Adult Immunoblastic Large Cell Lymphoma; Stage IV Adult Lymphoblastic Lymphoma; Stage IV Grade 1 Follicular Lymphoma; Stage IV Grade 2 Follicular Lymphoma; Stage IV Grade 3 Follicular Lymphoma; Stage IV Mantle Cell Lymphoma; Stage IV Marginal Zone Lymphoma; Stage IV Small Lymphocytic Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific |
National Cancer Institute (NCI) |
1999-06 | PHASE1 |
| NCT00119236 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
National Cancer Institute (NCI) |
2005-05 | PHASE1 |
| NCT00058253 | COMPLETED | Recurrent Prostate Cancer; Stage IV Prostate Cancer; Unspecified Adult Solid Tumor, Protocol Specific |
National Cancer Institute (NCI) |
2003-02 | PHASE1 |
| NCT00093821 | COMPLETED | Childhood Chronic Myelogenous Leukemia; Childhood Desmoplastic Small Round Cell Tumor; Disseminated Neuroblastoma; Metastatic Childhood Soft Tissue Sarcoma; Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Metastatic Osteosarcoma; Previously Treated Childhood Rhabdomyosarcoma; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Recurrent Childhood Rhabdomyosarcoma; Recurrent Childhood Soft Tissue Sarcoma; Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Recurrent Neuroblastoma; Recurrent Osteosarcoma |
National Cancer Institute (NCI) |
2004-09 | PHASE1 |
| NCT00087386 | TERMINATED | Recurrent Melanoma; Stage III Melanoma; Stage IV Melanoma |
National Cancer Institute (NCI) |
2004-06 | PHASE2 |
| NCT00004065 | COMPLETED | Bladder Cancer; Breast Cancer; Colorectal Cancer; Gastric Cancer; Head and Neck Cancer; Kidney Cancer; Leukemia; Lung Cancer; Melanoma (Skin); Ovarian Cancer; Prostate Cancer; Unspecified Adult Solid Tumor, Protocol Specific |
Memorial Sloan Kettering Cancer Center |
1999-07 | PHASE1 |
| NCT00003969 | Completed | Unspecified Adult Solid Tumor Protocol Specific |
Cancer Research UK|National Cancer Institute (NCI) |
1998-08 | Phase 1 |
| NCT00093405 | COMPLETED | Kidney Cancer |
Memorial Sloan Kettering Cancer Center |
2004-08 | PHASE2 |
| NCT00003969 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
Cancer Research UK |
1998-08 | PHASE1 |
| NCT00319930 | TERMINATED | Chronic Lymphocytic Leukemia |
Biogen |
2005-05 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2013-12-16)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Geldanamycin (NSC 122750) Solubility in DMSO
- Geldanamycin (NSC 122750) Stock Solution
- Geldanamycin (NSC 122750) Storage
- Geldanamycin (NSC 122750) Stability
- Geldanamycin (NSC 122750) Molecular Weight
- Geldanamycin (NSC 122750) SMILES
- Geldanamycin (NSC 122750) CAS Number
- Geldanamycin (NSC 122750) Chemical Structure (2D and 3D)
- Geldanamycin (NSC 122750) SDS|MSDS