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Poor trial recruitment
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This study will assess the effect of IT-101 on delaying cancer progression in patients with platinum sensitive ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12mg/m2/dose | Experimental | 12mg per meter squared per dose |
|
| 15mg/m2/dose | Experimental | 15mg per meter squared per dose |
|
| Placebo | Placebo Comparator | 5% dextrose infusion (placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IT-101 (12mg/m2/dose) | Drug | Patients who satisfy the inclusion/exclusion criteria will receive a blinded infusion of IT-101 (12mg/m2/dose) every other week until disease progression. |
| Measure | Description | Time Frame |
|---|---|---|
| To Compare the proportion of patients without evidence of disease progression at 30 weeks following randomization between IT-101 at 12 mg/m2/dose or 15 mg/m2/dose to a placebo infusion treatment administered every other week. | 30 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of adverse drug experiences between each treatment | 30 weeks | |
| Compare the frequency of drug-related toxicities between each treatment arm | 30 weeks | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan S Berek, MD, MMS | Professor and Chair, Department of Obstetrics and Gynecology Stanford University School of Medicine Stanford Cancer Center | Principal Investigator |
| Franco Muggia, MD | Anne Murnick Cogan and David H. Cogan Professor of Oncology, Director of the Division of Medical Oncology at NYU Medical Center, and Associate Director for Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Decatur Memorial Hospital, Clinical Research Department/ Cancer Care Specialists of Illinois | Decatur | Illinois | 62526 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16533788 | Background | Schluep 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. | |
| 16133526 | Background | Schluep 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. |
| Label | URL |
|---|---|
| Calando Pharmaceuticals Website | View source |
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| IT-101 (15mg/m2/dose) | Drug | Patients who satisfy the inclusion/exclusion criteria will receive an infusion of IT-101 (15mg/m2) every other week until disease progression. |
|
| 5% Dextrose (Placebo) | Drug | Patients who satisfy the inclusion/exclusion criteria will receive an infusion of placebo every other week until disease progression. |
|
| Compare Quality of Life (QOL, patient-reported) measures (FACT-O, FOSI) between treatment arms. |
| 30 weeks |
| University of Minnesota Medical Center |
| Minneapolis |
| Minnesota |
| 55455 |
| United States |
| Schwartz Gynecologic Onclology, PLLC | Brightwaters | New York | 11718 | United States |
| Gabrail Cancer Center | Canton | Ohio | 44718 | United States |
| Chattanooga GYN Oncology | Chattanooga | Tennessee | 97403 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| Riverside Gynecology & Oncology | Newport News | Virginia | 23601 | United States |
| 15981921 | Background | Cheng 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. |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C542292 | IT-101 |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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