Last reviewed · How we verify
NCT00158886
Oral Topotecan As A Radiosensitizing Agent In Rectal Cancer
Phase 1 trial testing Topotecan in Carcinoma, Renal Cell in 26 participants. Terminated before completion.
11 August 2006
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 8 November 2001 |
| Primary completion | 11 August 2006 |
| Estimated completion | 11 August 2006 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Topotecan (topotecan) — full drug profile →
- Radiation therapy — full drug profile →
Conditions studied
- Carcinoma, Renal Cell — all drugs for Carcinoma, Renal Cell →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
18 and older, any sex, with Carcinoma, Renal Cell. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients with rectal cancer who are candidates for pre-operative radiation therapy may be enrolled in the Phase I, single center study. Patients will have a full blood count, biochemistry, urinalysis, and ECG for safety evaluation. Sequential cohorts of three patients will be given increasing doses of oral topotecan and fixed doses of concurrent radiation (45 Gy) over five weeks. The starting dose of oral topotecan is 0.25 mg/m2 to be concomitantly administered with radiation (45 Gy) x 5 days every week unless the radiation is interrupted for Holidays/Weekends or toxicity requiring treatment delays occurs. A total of 25 doses are planned.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Advancing cancer radiotherapy: Harnessing radiosensitizers and nanotechnology for enhanced tumor control.
Shiridokht F, Kehtari P, Eskandani M, Farajollahi A, et al · · 2025 · PMID 41189671 · DOI 10.1016/j.ijpx.2025.100419
Verify or expand the search:
- PubMed search for NCT00158886
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Topotecan
Trials testing the same drug.
- NCT07437963 — Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatmen · Phase 1, PHASE2 · not yet recruiting
- NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
- NCT06930755 — Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer · Phase 1 · recruiting
- NCT07321912 — Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma · Phase 2 · not yet recruiting
- NCT06425419 — The Safety and Efficacy of Intravitreal Topotecan for the Treatment of Proliferative Vitreoretinopathy · Phase 1 · not yet recruiting
Other recruiting trials for Carcinoma, Renal Cell
Currently open trials in the same condition.
- NCT07405164 — Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) · Phase 3 · recruiting
- NCT07227415 — Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Antica · Phase 1, PHASE2 · recruiting
- NCT06222593 — Study to Evaluate the Safety and Efficacy of Bicalutamide in Combination With Sunitinib in Patients With TKIs-resistant · Phase 1, PHASE2 · recruiting
- NCT07166445 — Deep Learning for Automated Discrimination Between Stage T1-T2 and T3 Renal Cell Carcinoma on Contrast-Enhanced CT · recruiting
- NCT06676527 — Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma · recruiting
Other GlaxoSmithKline trials
Trials by the same sponsor.
- NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
- NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
- NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
- NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
- NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00158886 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
- Last refreshed: 14 November 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00158886.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing