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NCT00889382
A Study Evaluating Intermittent and Continuous OSI-906 and Weekly Paclitaxel in Patients With Recurrent Epithelial Ovarian Cancer (and Other Solid Tumors)
Phase 1, PHASE2 trial testing OSI-906 in Ovarian Cancer in 152 participants. Completed in 25 August 2014.
1 August 2014
Quick facts
| Lead sponsor | Astellas Pharma Inc |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 152 |
| Start date | 5 August 2009 |
| Primary completion | 1 August 2014 |
| Estimated completion | 25 August 2014 |
| Sites | 46 locations across Italy, Russia, United Kingdom, Poland, Romania, Canada, Switzerland, Australia |
Drugs / interventions tested
- OSI-906 — full drug profile →
- Paclitaxel — full drug profile →
Conditions studied
- Ovarian Cancer — all drugs for Ovarian Cancer →
- Solid Tumors — all drugs for Solid Tumors →
Sponsor
Astellas Pharma Inc — full company profile →
Who can join
18 and older, any sex, with Ovarian Cancer or Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multi-center, randomized, open-label, phase 1/2 study of continuous weekly paclitaxel and escalating doses of intermittent or continuous OSI-906 in patients with recurrent/relapsed ovarian and other solid tumors.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Molecular Pathways: Clinical Applications and Future Direction of Insulin-like Growth Factor-1 Receptor Pathway Blockade.
Iams WT, Lovly CM. · · 2015 · cited 144× · PMID 26429980 · DOI 10.1158/1078-0432.ccr-14-2518 -
New perspectives on targeted therapy in ovarian cancer.
Coward JI, Middleton K, Murphy F. · · 2015 · cited 77× · PMID 25678824 · DOI 10.2147/ijwh.s52379 -
The insulin-like growth factor 1 pathway is a potential therapeutic target for low-grade serous ovarian carcinoma.
King ER, Zu Z, Tsang YT, Deavers MT, et al · · 2011 · cited 44× · PMID 21726895 · DOI 10.1016/j.ygyno.2011.06.016 -
Phase 2 study evaluating intermittent and continuous linsitinib and weekly paclitaxel in patients with recurrent platinum resistant ovarian epithelial cancer.
Oza A, Kaye S, Van Tornout J, Sessa C, et al · · 2018 · cited 31× · PMID 29454514 · DOI 10.1016/j.ygyno.2018.01.019 -
The insulin and igf-I pathway in endocrine glands carcinogenesis.
Malaguarnera R, Morcavallo A, Belfiore A. · · 2012 · cited 20× · PMID 22927847 · DOI 10.1155/2012/635614 -
Modulation of insulin-like growth factor-1 receptor and its signaling network for the treatment of cancer: current status and future perspectives.
Jin M, Buck E, Mulvihill MJ. · · 2013 · cited 15× · PMID 25992224 · DOI 10.4081/oncol.2013.e3 -
Dietary or pharmacological inhibition of insulin-like growth factor-1 protects from renal ischemia-reperfusion injury in mice.
Lyon A, Agius T, Macarthur MR, Kiesworo K, et al · · 2024 · cited 2× · PMID 39759002 · DOI 10.1016/j.isci.2024.111256 -
The surgical, histopathological characteristics, and survival outcome of ovarian clear cell carcinoma: a retrospective case series sharing the experience of a tertiary cancer centre.
El Tawab S, Nistor S, Roux R, Manek S, et al · · 2024 · cited 2× · PMID 39430857 · DOI 10.21037/tcr-24-83
Verify or expand the search:
- PubMed search for NCT00889382
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of OSI-906
Trials testing the same drug.
- NCT01529684 — A Study to Look at How a Single Oral Dose of 14C-OSI-906 is Absorbed, Broken Down and Eliminated in the Body · Phase 1 · completed
- NCT01221077 — Study of Erlotinib (Tarceva®) in Combination With OSI-906 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) W · Phase 2 · completed
- NCT01186861 — Phase 2 Study of Maintenance OSI-906 Plus Erlotinib (Tarceva®), or Placebo Plus Erlotinib in Patients With Nonprogressio · Phase 2 · completed
- NCT01101906 — A Randomized, Placebo-controlled, Double-blind Phase 2 Study With OSI-906 in Patients With Advanced HCC · Phase 2 · terminated
- NCT00924989 — A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma · Phase 3 · completed
Other recruiting trials for Ovarian Cancer
Currently open trials in the same condition.
- NCT06412120 — Study Evaluating Safety, Tolerability, and Metabolism of Niraparib · Phase 4 · recruiting
- NCT06930755 — Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer · Phase 1 · recruiting
- NCT07318558 — A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021) · Phase 3 · recruiting
- NCT07491081 — EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection · NA · recruiting
- NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
Other Astellas Pharma Inc trials
Trials by the same sponsor.
- NCT07318714 — A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke · Phase 1, PHASE2 · recruiting
- NCT07094204 — A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors · Phase 1 · recruiting
- NCT06970665 — A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Ma · Phase 4 · recruiting
- NCT06364696 — A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors · Phase 1 · active not recruiting
- NCT06206421 — A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause · Phase 3 · completed
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 NCT00889382 (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 Astellas Pharma Inc
- Last refreshed: 20 November 2024
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/NCT00889382.
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