Clinical trial · Interventional
A Phase 2 Study to Investigate the Clinical Activity of IPI-504 in Patients With Hormone-resistant Prostate Cancer
A Phase 2 Open-Label Study to Investigate the Pharmacodynamics and Clinical Activity of IPI-504 in Patients With Castration-Resistant Prostate Cancer Stratified by Prior Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine: * Anti-tumor activity of IPI-504 in 2 groups of subjects with hormone resistant prostate cancer. * Group A - subjects who have not previously received chemotherapy * Group B - sujects who have received prior chemotherapy or could not tolerate chemotherapy. * Clinical response will be determined by PSA and radiological response
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Prostate | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IPI-504 | Drug | Retaspimycin Hydrochloride | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IPI-504: Group A
- description
- No Prior treatment for prostate cancer with cytotoxic chemotherapy (adjuvant or neoadjuvant chemotherapy is acceptable if completed \>2 years prior to study)
- interventionNames
- Drug: IPI-504
- type
- EXPERIMENTAL
- label
- IPI-504: Group B
- description
- * Must have evidence of radiographic metastatic disease * Must have been treated with a docetaxel-based chemotherapy regimen for HRPC with a minimum of 2 cycles with either PSA or RECIST defined radiographic progression during or witin 60 days of completeing docetaxel based chemotheraph or be intolerant of docetaxel-based chemotherapy * No more than three prior chemotherapies regimens for HRPC
- interventionNames
- Drug: IPI-504
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adenocarcinoma of the prostate * Resolution of acute toxic side effects of prior chemotherapy * Castration resistant disease despite ongoing chemical or surgical castration * ECOG 0-1 * PSA greater than or equal to 2 * Group A - * No Prior treatment for prostate cancer with cytotoxic chemotherapy (neoadjuvant, adjuvant treatment permitted if more than 2 years out) * Group B * Radiographic evidence of metastatic disease * Prior tx with docetaxel-minimum of 2 cycles with progression by RECIST or PSA or intolerant of tx * Maximum of 3 prior chemotherapies Exclusion Criteria: * Small cell carcinoma of the prostate * Treatment within 2 weeks with approved, investigational, or small molecule * Treatment within 4 weeks with biologic or external beam radiation * ANC \<1,500 cells m3; Platelets \<100,000 mm3; Hemoglobin \<9.0g/dL * AST/ALT \>2.5 ULN * Serum creatinine \>3.0mg/dL * Active keratitis or keratoconjunctivitis * Previous treatment with 17-AAG, DMAG; or any other HSP-90 inhibitor * Baseline Qtc \>450 mses
References
Publications (0)
Data not yet available