Ovarian CancerPhase 2NCT00442598
Safety and Efficacy Study of Glufosfamide in Ovarian Cancer
A Phase 2 study testing Glufosfamide in people with Ovarian Cancer, run by Eleison Pharmaceuticals LLC. at 10 sites in United States.
Trial summary
Primary Objectives: To evaluate the effect of glufosfamide on the serum concentrations of CA125 in subjects with ovarian cancer To evaluate the safety of weekly glufosfamide dosing in subjects with ovarian cancer as compared with every 21-day dosing Secondary objectives: To evaluate the efficacy of glufosfamide in… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Glufosfamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 10 sitesUnited States
- Study dates
- Jan 2007to Apr 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
- Pathologically confirmed epithelial ovarian cancer, peritoneal serous cancer, or carcinoma of the fallopian tube
- Prior treatment with at least one platinum-based chemotherapy
- Evidence of resistance to most recent platinum-containing regimen (relapsed during or within 6 months after completing chemotherapy)
- Evidence of CA 125 progression after most recent chemotherapy defined as either:
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- CA 125 at least 40 U/mL for patients with elevated CA 125 that decreased to <20 U/mL on therapy; or
- CA 125 at least 40 U/mL and at least a 50% increase over the nadir value for patients with elevated CA 125 that did not decrease to <20 U/mL on therapy.
- CA 125 must meet criteria on two occasions not less than one week apart if the CA 125 has increased by at least 100% (i.e., doubled). There must be 3 consecutive increasing measurements over a period of at least two weeks if the CA 125 has increased by at least 50% but less than 100%.
- Elevated serum CA125 (≥40 U/mL) within 2 weeks prior to starting treatment
- At least one target or nontarget lesion by RECIST
- A minimum of 21 days between prior chemotherapy, radiation therapy, immunotherapy, or other anti-tumor therapy and study entry
- Recovered from reversible toxicities of prior therapy
- ECOG score of 0 or 1
- ANC ≥ 1,500/µL, platelets ≥ 100,000/µL, hemoglobin ≥9 g/dL
- Total bilirubin ≤ 1.5-fold ULN, AST/ALT ≤ 2.5-fold ULN (≤ 5-fold ULN if liver metastases)
- Creatinine clearance ≥ 60 mL/min (calculated by Cockcroft-Gault formula)
- All women of childbearing potential must have a negative serum pregnancy test and must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose
Who cannot join
- Concomitant or planned hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for ovarian cancer other than protocol therapy
- Symptomatic brain metastases
- Active clinically significant infection requiring antibiotics
- Known HIV positive or active hepatitis B or C
- Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, congestive heart failure or stroke
- Other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past 5 years
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- Major surgery within 3 weeks of the start of study treatment, without complete recovery
- Females who are pregnant or breast-feeding
- Participation in an investigational drug or device study within 28 days of the first day of dosing on this study
- Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
- Unwillingness or inability to comply with the study protocol for any other reason
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, 87106
Harrington Cancer Center
Amarillo, Texas, 79106
Gabrail Cancer Center
Canton, Ohio, 44718
California Cancer Center
Greenbrae, California, 94904
Gynecologic Oncology Research & Development, LLC
Greenville, South Carolina, 29601
Indiana University Cancer Center
Indianapolis, Indiana, 46202
Louisville Oncology Clinical Research Program
Louisville, Kentucky, 40202
UCI Chao Family Comprehensive Cancer Center
Orange, California, 92868
Premiere Oncology of Arizona
Scottsdale, Arizona, 85260
Arizona Cancer Center
Tucson, Arizona, 85724
About this study
Official title: An Open-Label Phase 2 Study of the Safety and Efficacy of Glufosfamide in Ovarian Cancer
Primary Objectives:
- To evaluate the effect of glufosfamide on the serum concentrations of CA125 in subjects with ovarian cancer
- To evaluate the safety of weekly glufosfamide dosing in subjects with ovarian cancer as compared with every 21-day dosing
Secondary objectives:
- To evaluate the efficacy of glufosfamide in subjects with ovarian cancer as measured by objective response rate, duration of response, progression-free survival, and overall survival
- To evaluate the pharmacokinetics of glufosfamide and isophosphoramide mustard during and after treatment
Exploratory objective:
- To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins
Read the detailed description
Open-label, multicenter, Phase 2 dose escalation study. Subjects will be randomized to receive either once every three weeks dosing regimen or the weekly dosing regimen. Randomization will utilize a 2:1 ratio with two-thirds of the subjects randomized to the weekly dosing regimen.
In the weekly dosing schedule, treatment with glufosfamide 2,500 mg/m2 will be initiated only after the 1,660 mg/m2 treatment cohort has been enrolled and there is evidence that the dose of 1,660 mg/m2 has been well tolerated (See below Section on Pharmacokinetic/Statistical Analyses).
- Conditions
- Ovarian Cancer
- Being tested
- Glufosfamide
- Keywords
- Ovarian, Cancer, CA-125, Third-line, Glufosfamide
- Medical subject headings
- Ovarian Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlufosfamideDrug
| Study group | Role | What they receive |
|---|---|---|
| Glufosfamide q21 days | Experimental | 1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle Receives: Drug: Glufosfamide |
| Glufosfamide q7 days low | Experimental | 1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle Receives: Drug: Glufosfamide |
| Glufosfamide q7 days high | Experimental | 1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle Receives: Drug: Glufosfamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
CA 125 Response Rate
Reduction in blood levels of CA 125 of >50% from baseline, confirmed at the next study cycle.
Measured: Duration of study, up to 18 weeks.
Secondary outcomes (3)
Objective Response Rate
Objective response rate measured by RECIST v1.0
Measured: Duration of study, up to 18 weeks.
Progression-free Survival
Time from initiation of study drug to disease progression or death on study
Measured: Median measured in months
Overall Survival
Time from initiation of study drug to death.
Measured: Median measured in months, until death or censorship at analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2007 (estimated)
- Study startJan 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian 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
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eleison Pharmaceuticals LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Alberts, MD, Principal investigator, University of ArizonaMichael Gordon, MD, Principal investigator, Premiere Oncology of ArizonaDaniela Matei, MD, Principal investigator, Indiana UniversityPeter D Eisenberg, MD, Principal investigator, California Cancer CenterLarry Puls, MD, Principal investigator, Gynecologic Oncology Research & Development, LLCKrishnansu Tewari, MD, Principal investigator, UCI Chao Family Comprehensive Cancer CenterNashat Gabrail, MD, Principal investigator, Gabrail Cancer CenterJeffrey Goldberg, MD, Principal investigator, Louisville Oncology Clinical Research Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442598
- Sponsor's protocol ID
- TH-CR-303
- Status last verified
- Mar 2015
- First submitted
- 28 Feb 2007
- Last updated
- 10 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 2 Study of the Safety and Efficacy of Glufosfamide in Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00442598
- Acronym / sponsor ID
- TH-CR-303
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian, Cancer, CA-125, Third-line, Glufosfamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Eleison Pharmaceuticals LLC.Industry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 2 Mar 2007 (estimated)
- Results
- Posted 10 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
- To evaluate the effect of glufosfamide on the serum concentrations of CA125 in subjects with ovarian cancer
- To evaluate the safety of weekly glufosfamide dosing in subjects with ovarian cancer as compared with every 21-day dosing
Secondary objectives:
- To evaluate the efficacy of glufosfamide in subjects with ovarian cancer as measured by objective response rate, duration of response, progression-free survival, and overall survival
- To evaluate the pharmacokinetics of glufosfamide and isophosphoramide mustard during and after treatment
Exploratory objective:
- To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins
Detailed description
Open-label, multicenter, Phase 2 dose escalation study. Subjects will be randomized to receive either once every three weeks dosing regimen or the weekly dosing regimen. Randomization will utilize a 2:1 ratio with two-thirds of the subjects randomized to the weekly dosing regimen.
In the weekly dosing schedule, treatment with glufosfamide 2,500 mg/m2 will be initiated only after the 1,660 mg/m2 treatment cohort has been enrolled and there is evidence that the dose of 1,660 mg/m2 has been well tolerated (See below Section on Pharmacokinetic/Statistical Analyses).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glufosfamide q21 days | Experimental | Drug: Glufosfamide1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle |
| Glufosfamide q7 days low | Experimental | Drug: Glufosfamide1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle |
| Glufosfamide q7 days high | Experimental | Drug: Glufosfamide1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- At least 18 years of age
- Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
- Pathologically confirmed epithelial ovarian cancer, peritoneal serous cancer, or carcinoma of the fallopian tube
- Prior treatment with at least one platinum-based chemotherapy
- Evidence of resistance to most recent platinum-containing regimen (relapsed during or within 6 months after completing chemotherapy)
Key exclusion criteria (11 listed)
- Concomitant or planned hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for ovarian cancer other than protocol therapy
- Symptomatic brain metastases
- Active clinically significant infection requiring antibiotics
- Known HIV positive or active hepatitis B or C
- Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, congestive heart failure or stroke
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 |
|---|---|---|
| Glufosfamide | Drug | Glufosfamide q21 days, Glufosfamide q7 days high, Glufosfamide q7 days low |
Primary outcome
CA 125 Response Rate
Time frame: Duration of study, up to 18 weeks.
Reduction in blood levels of CA 125 of >50% from baseline, confirmed at the next study cycle.
3 secondary outcomes
Objective Response Rate
Time frame: Duration of study, up to 18 weeks.
Progression-free Survival
Time frame: Median measured in months
Overall Survival
Time frame: Median measured in months, until death or censorship at analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Alberts, MD principal investigator
University of Arizona
Michael Gordon, MD principal investigator
Premiere Oncology of Arizona
Daniela Matei, MD principal investigator
Indiana University
10 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 Glufosfamide in people with Ovarian Cancer, run by Eleison Pharmaceuticals LLC. at 10 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 18 inclusion and 11 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: stopped early, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. 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?
Yes. Results are posted in the registry (first posted 10 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
CA 125 Response Rate (time frame: Duration of study, up to 18 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2015.