CancerPhase 2NCT00753740
Efficacy Study of Maintenance IT-101 Therapy for Ovarian Cancer Patients.
A Phase 2 study testing IT-101 (12mg/m2/dose) and IT-101 (15mg/m2/dose) in people with Cancer and Ovarian Cancer, run by NewLink Genetics Corporation at 7 sites in United States.
Trial summary
This study will assess the effect of IT-101 on delaying cancer progression in patients with platinum sensitive ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 to 78 years, women only
- Conditions the study is for
- Cancer, Ovarian Cancer, Solid Tumor
- What is being tested?
- IT-101 (12mg/m2/dose) and IT-101 (15mg/m2/dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 7 sitesUnited States
- Study dates
- Sep 2008to May 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Schwartz Gynecologic Onclology, PLLC
Brightwaters, New York, 11718
Gabrail Cancer Center
Canton, Ohio, 44718
Chattanooga GYN Oncology
Chattanooga, Tennessee, 97403
Decatur Memorial Hospital, Clinical Research Department/ Cancer Care Specialists of Illinois
Decatur, Illinois, 62526
The Methodist Hospital
Houston, Texas, 77030
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Riverside Gynecology & Oncology
Newport News, Virginia, 23601
About this study
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.
This study will assess the effect of IT-101 on delaying cancer progression in patients with platinum sensitive ovarian cancer.
- Conditions
- Cancer, Ovarian Cancer, Solid Tumor
- Being tested
- IT-101 (12mg/m2/dose), IT-101 (15mg/m2/dose), 5% Dextrose (Placebo)
- Keywords
- Cancer, Neoplasms, Solid Tumor, Ovarian Cancer, Solid Malignancies
- Medical subject headings
- Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 12mg/m2/dose | Experimental | 12mg per meter squared per dose Receives: Drug: IT-101 (12mg/m2/dose) |
| 15mg/m2/dose | Experimental | 15mg per meter squared per dose Receives: Drug: IT-101 (15mg/m2/dose) |
| Placebo | Placebo comparator | 5% dextrose infusion (placebo) Receives: Drug: 5% Dextrose (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 weeks
Secondary outcomes (3)
Comparison of adverse drug experiences between each treatment
Measured: 30 weeks
Compare the frequency of drug-related toxicities between each treatment arm
Measured: 30 weeks
Compare Quality of Life (QOL, patient-reported) measures (FACT-O, FOSI) between treatment arms.
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionOct 2009
- Study completionMay 2010
Why it stopped: Poor trial recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NewLink Genetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan S Berek, MD, MMS, Principal investigator, Professor and Chair, Department of Obstetrics and Gynecology Stanford University School of Medicine Stanford Cancer CenterFranco Muggia, MD, Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753740
- Sponsor's protocol ID
- OVAR0801
- Status last verified
- Jun 2020
- First submitted
- 12 Sep 2008
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16533788Schluep 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.
PubMed 16133526Cheng 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.
PubMed 15981921
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00753740
- Acronym / sponsor ID
- OVAR0801
- Conditions
- Cancer, Ovarian Cancer, Solid Tumor
- Keywords
- Cancer, Neoplasms, Solid Tumor, Ovarian Cancer, Solid Malignancies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Poor trial recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NewLink Genetics CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 16 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the effect of IT-101 on delaying cancer progression in patients with platinum sensitive ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 12mg/m2/dose | Experimental | Drug: IT-101 (12mg/m2/dose)12mg per meter squared per dose |
| 15mg/m2/dose | Experimental | Drug: IT-101 (15mg/m2/dose)15mg per meter squared per dose |
| Placebo | Placebo comparator | Drug: 5% Dextrose (Placebo)5% dextrose infusion (placebo) |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IT-101 (12mg/m2/dose)Patients who satisfy the inclusion/exclusion criteria will receive a blinded infusion of IT-101 (12mg/m2/dose) every other week until disease progression. | Drug | 12mg/m2/dose |
| IT-101 (15mg/m2/dose)Patients who satisfy the inclusion/exclusion criteria will receive an infusion of IT-101 (15mg/m2) every other week until disease progression. | Drug | 15mg/m2/dose |
| 5% Dextrose (Placebo)Patients who satisfy the inclusion/exclusion criteria will receive an infusion of placebo every other week until disease progression. | Drug | Placebo |
Primary outcome
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.
Time frame: 30 weeks
3 secondary outcomes
Comparison of adverse drug experiences between each treatment
Time frame: 30 weeks
Compare the frequency of drug-related toxicities between each treatment arm
Time frame: 30 weeks
Compare Quality of Life (QOL, patient-reported) measures (FACT-O, FOSI) between treatment arms.
Time frame: 30 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Background: PubMed 16533788Schluep 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.
- Background: PubMed 16133526Schluep 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.
- Background: PubMed 15981921Cheng 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.
- Calando Pharmaceuticals WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan S Berek, MD, MMS principal investigator
Professor and Chair, Department of Obstetrics and Gynecology Stanford University School of Medicine Stanford Cancer Center
Franco Muggia, MD principal investigator
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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IT-101 (12mg/m2/dose) and IT-101 (15mg/m2/dose) in people with Cancer and Ovarian Cancer, run by NewLink Genetics Corporation at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 30 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00753740, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.