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Efficacy Study of Maintenance IT-101 Therapy for Ovarian Cancer Patients.

Primary Purpose

Cancer, Ovarian Cancer, Solid Tumor

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

IT-101 (12mg/m2/dose)

IT-101 (15mg/m2/dose)

5% Dextrose (Placebo)

About this trial

This is an interventional treatment trial for Cancer focused on measuring Cancer, Neoplasms, Solid Tumor, Ovarian Cancer, Solid Malignancies

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Decatur Memorial Hospital, Clinical Research Department/ Cancer Care Specialists of Illinois
University of Minnesota Medical Center
Schwartz Gynecologic Onclology, PLLC
Gabrail Cancer Center
Chattanooga GYN Oncology
The Methodist Hospital
Riverside Gynecology & Oncology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

12mg/m2/dose

15mg/m2/dose

Placebo

Arm Description

12mg per meter squared per dose

15mg per meter squared per dose

5% dextrose infusion (placebo)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Comparison of adverse drug experiences between each treatment

Compare the frequency of drug-related toxicities between each treatment arm

Compare Quality of Life (QOL, patient-reported) measures (FACT-O, FOSI) between treatment arms.

Full Information

NCT ID

NCT00753740

First Posted

September 12, 2008

Last Updated

June 10, 2020

Sponsor

NewLink Genetics Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00753740

Brief Title

Efficacy Study of Maintenance IT-101 Therapy for Ovarian Cancer Patients.

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Poor trial recruitment

Study Start Date

September 2008 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NewLink Genetics Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will assess the effect of IT-101 on delaying cancer progression in patients with platinum sensitive ovarian cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer, Ovarian Cancer, Solid Tumor

Keywords

Cancer, Neoplasms, Solid Tumor, Ovarian Cancer, Solid Malignancies

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

12mg/m2/dose

Arm Type

Experimental

Arm Description

12mg per meter squared per dose

Arm Title

15mg/m2/dose

Arm Type

Experimental

Arm Description

15mg per meter squared per dose

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

5% dextrose infusion (placebo)

Intervention Type

Drug

Intervention Name(s)

IT-101 (12mg/m2/dose)

Intervention Description

Patients who satisfy the inclusion/exclusion criteria will receive a blinded infusion of IT-101 (12mg/m2/dose) every other week until disease progression.

Intervention Type

Drug

Intervention Name(s)

IT-101 (15mg/m2/dose)

Intervention Description

Patients who satisfy the inclusion/exclusion criteria will receive an infusion of IT-101 (15mg/m2) every other week until disease progression.

Intervention Type

Drug

Intervention Name(s)

5% Dextrose (Placebo)

Intervention Description

Patients who satisfy the inclusion/exclusion criteria will receive an infusion of placebo every other week until disease progression.

Primary Outcome Measure Information:

Title

Time Frame

30 weeks

Secondary Outcome Measure Information:

Title

Comparison of adverse drug experiences between each treatment

Time Frame

30 weeks

Title

Compare the frequency of drug-related toxicities between each treatment arm

Time Frame

30 weeks

Title

Compare Quality of Life (QOL, patient-reported) measures (FACT-O, FOSI) between treatment arms.

Time Frame

30 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

78 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan S Berek, MD, MMS

Organizational Affiliation

Professor and Chair, Department of Obstetrics and Gynecology Stanford University School of Medicine Stanford Cancer Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Franco Muggia, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Decatur Memorial Hospital, Clinical Research Department/ Cancer Care Specialists of Illinois

City

Decatur

State/Province

Illinois

ZIP/Postal Code

62526

Country

United States

Facility Name

University of Minnesota Medical Center

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

Schwartz Gynecologic Onclology, PLLC

City

Brightwaters

State/Province

New York

ZIP/Postal Code

11718

Country

United States

Facility Name

Gabrail Cancer Center

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

Country

United States

Facility Name

Chattanooga GYN Oncology

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

97403

Country

United States

Facility Name

The Methodist Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Riverside Gynecology & Oncology

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23601

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16533788

Citation

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.

Results Reference

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PubMed Identifier

16133526

Citation

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.

Results Reference

background

PubMed Identifier

15981921

Citation

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.

Results Reference

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Efficacy Study of Maintenance IT-101 Therapy for Ovarian Cancer Patients.

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