Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00348595 · ClinicalTrials.gov registry record · Phase 1
Study of 2 Different Doses of Revlimid in Biochemically Relapse Prostate Cancer
A Phase 1 study of Prostate Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 1
- Development phase
- 77
- Enrollment target
- 1
- Study location
NCT00348595: Completed Phase 1 study of Prostate Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT00348595 is a Phase 1 study of Prostate Cancer that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 77 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00348595, a Phase 1 study of Prostate Cancer, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 77 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objectives of the study are: * To evaluate feasibility, safety and tolerance of 6 months administration of Revlimid at 5mg/day and 25mg/day, given orally in subjects with prostate cancer with evidence of biochemical relapse (M0) following local treatment (i.e., surgery or radiation). * To assess the rate of PSA (prostatic specific antigen) progression at 6 months after treatment with 5mg/day and 25mg/day of Revlimid (CC-5013) in patients with evidence of biochemical relapse after local therapy. The secondary objectives of the study are: * To provide preliminary assessments on the effects of Revlimid (CC-5013) at 5mg/day and 25mg/day on various PSA constructs in the subject population (i.e., PSADT \[Prostatic Specific Antigen Doubling Time\] and PSA slope) by comparing pre and post treatment patterns in each arm. * To evaluate preliminary pharmacodynamic correlations between serum revlimid concentrations and toxicity, PSA constructs and other evidence of disease progression.
Primary Outcome
Number of participants experiencing Grade 3 and 4 adverse events as defined by the National Cancer Institute Common Toxicity Criteria version 3.0
Conditions Studied
Interventions
- DRUG Revlimid
Study Locations (1)
Maryland
- The Harry and Jeanette Weinberg Building - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2006-07-20 |
| Est. Completion | 2016-06-29 |
| Phase | Phase 1 |
What the finished NCT00348595 record still lists
NCT00348595 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Revlimid is the first listed.
NCT00348595 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00348595 about?
NCT00348595 is a clinical study titled "Study of 2 Different Doses of Revlimid in Biochemically Relapse Prostate Cancer". The primary objectives of the study are: * To evaluate feasibility, safety and tolerance of 6 months administration of Revlimid at 5mg/day and 25mg/day, given orally in subjects with prostate cancer with evidence of biochemical relapse (M0) following local treatment (i.e., surgery or radiation). * ...
What is the current status of trial NCT00348595?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2006-07-20. Estimated completion is 2016-06-29.
What conditions does trial NCT00348595 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT00348595?
The interventions under investigation include: Revlimid (DRUG).
Who is sponsoring clinical trial NCT00348595?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00348595 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00348595's enrollment target sits among peer trials
77 385th of 735 higher than 349 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors
RECRUITING · Phase 1
-
Phase 1 Trial of ZM008 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
RECRUITING · Phase 1
-
Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy
RECRUITING · Phase 1
-
A Study to Learn How Safe AZD6621 is, How Well it Works, and How it Moves Throughout the Body Over Time, in Adult Male Participants With Metastatic Prostate Cancer
RECRUITING · Phase 1
-
Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02127398 · 77 participants · Phase 2
Stool Transplants to Treat Refractory Clostridium Difficile Colitis
- NCT04159103 · 77 participants · Phase 1
Open-Label Study of mRNA-3927 in Participants With Propionic Acidemia
- NCT04683003 · 77 participants · Phase 3
A Study of TAK-755 in Participants With Congenital Thrombotic Thrombocytopenic Purpura
- NCT05004116 · 77 participants · Phase 1
A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI