Clinical trial · Interventional
Efficacy Study of Maintenance IT-101 Therapy for Ovarian Cancer Patients.
A Phase II Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of Maintenance IT-101 in Platinum Sensitive Ovarian Cancer Patients Who Received 4-6 Cycles of a 2nd Line Platinum-Based Regimen Without Disease Progression.
NCT00753740CI-TRIAL-00045524withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor trial recruitment
Summary
Brief summary (as posted)
This study will assess the effect of IT-101 on delaying cancer progression in patients with platinum sensitive ovarian cancer.
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 | Malignant Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5% Dextrose (Placebo) | Drug | — | UNRESOLVED |
| IT-101 (12mg/m2/dose) | Drug | — | UNRESOLVED |
| IT-101 (15mg/m2/dose) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 12mg/m2/dose
- description
- 12mg per meter squared per dose
- interventionNames
- Drug: IT-101 (12mg/m2/dose)
- type
- EXPERIMENTAL
- label
- 15mg/m2/dose
- description
- 15mg per meter squared per dose
- interventionNames
- Drug: IT-101 (15mg/m2/dose)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 5% dextrose infusion (placebo)
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 78 Years
Show eligibility criteria text
Key Inclusion Criteria: * Women between the age of 18 and 78, inclusive; * Evidence of platinum-sensitive ovarian cancer following the patient's primary treatment(\>= 6 months); * Received a 2nd line platinum-based chemotherapy regimen (4-6 cycles) without evidence of progression; * May have measurable or unmeasurable disease; * Eastern Cooperative Oncology Group (ECOG) 0 or 1; * Ability to understand and the willingness to sign a written informed consent document. Key Exclusion Criteria: * Women who are pregnant or lactating; * Prior treatment with a topoisomerase inhibitor; * Patients with unacceptable organ and/or hematologic reserve at screening; * Urine protein of \> 500 mg/day or active nephropathy; * Electrocardiogram (ECG) with evidence of clinically significant conduction abnormalities or active ischemia as determined by the investigator; * History of pancreatitis within the last 12 months; * Patients treated with previous high dose chemotherapy or stem cell transplant within the last 5 years; * Use of any investigational agents within 4 weeks of study enrollment; * Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, psychiatric illness or other co-morbidity that presents a risk to the patient as determined by the investigator.
References
Publications (3)
- BACKGROUNDSchluep T, Hwang J, Cheng J, Heidel JD, Bartlett DW, Hollister B, Davis ME. Preclinical efficacy of the camptothecin-polymer conjugate IT-101 in multiple cancer models. Clin Cancer Res. 2006 Mar 1;12(5):1606-14. doi: 10.1158/1078-0432.CCR-05-1566. PMID 16533788
- BACKGROUNDSchluep T, Cheng J, Khin KT, Davis ME. Pharmacokinetics and biodistribution of the camptothecin-polymer conjugate IT-101 in rats and tumor-bearing mice. Cancer Chemother Pharmacol. 2006 May;57(5):654-62. doi: 10.1007/s00280-005-0091-7. Epub 2005 Aug 26. PMID 16133526
- BACKGROUNDCheng J, Khin KT, Davis ME. Antitumor activity of beta-cyclodextrin polymer-camptothecin conjugates. Mol Pharm. 2004 May-Jun;1(3):183-93. doi: 10.1021/mp049966y. PMID 15981921