NeoplasmsPhase 1/2NCT00102752
Study of Safety and Efficacy of Glufosfamide in Combination With Gemcitabine in Cancer
A Phase 1/2 study testing Glufosfamide and Gemcitabine in people with Neoplasms and Pancreatic Neoplasms, run by Threshold Pharmaceuticals at 9 sites in 2 countries.
Trial summary
The purpose of this study is to determine the safety of glufosfamide when administered in combination with gemcitabine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Pancreatic Neoplasms
- What is being tested?
- Glufosfamide and Gemcitabine
- How many people
- 47 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Dec 2004to Jul 2007
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Histologically or cytologically confirmed, locally advanced or metastatic solid malignancy; previously treated with at least one chemotherapy regimen for advanced or metastatic disease or no effective standard treatment is available OR
- Metastatic and/or locally advanced, inoperable pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided)
- Measurable or nonmeasurable disease by RECIST criteria (at least one target or nontarget lesion)
- Recovered from reversible toxicities of prior therapy
- Karnofsky performance status ≥70
- Women of childbearing potential and men to use effective means of contraception from entry into the study through 6 months after the last dose
- Ability to understand the purposes and risks of the study and provide written informed consent.
Who cannot join
- Prior chemotherapy for metastatic/locally advanced pancreatic cancer
- Prior administration of gemcitabine
- Radiation therapy within 28 days prior to study start
- Hormonal therapy, biologic therapy, chemotherapy or other systemic anti-tumor therapy for cancer within 21 days prior to study start
- Symptomatic brain metastases (baseline CT scan is not required in asymptomatic subjects)
- Active, clinically significant infection requiring antibiotics
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- Known HIV positive or active hepatitis B or C
- History or symptoms of cardiovascular disease (NYHA Class 3 or 4)
- Other primary malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past 5 years
- Major surgery within 3 weeks of the start of study treatment, without complete recovery
- Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including electrolytes, and urinalysis)
- Hemoglobin <9 g/dL (may receive transfusion or erythropoietin to maintain),
- ANC <1500/μL,
- Platelet count <100,000/μL,
- Total bilirubin > 1.5 ×ULN,
- AST/ALT > 2.5-fold above ULN (>5-fold above ULN if liver metastases),
- Serum creatinine > 2 mg/dL,
- Creatinine clearance < 60 mL/min (calculated)
- 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
- Unwillingness or inability to comply with the study protocol for any other reason
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Brazil6 sites
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, 14784-400
Hospital de Doenças Cardiovasculares - Biocor
Nova Lima, BH, 34000-000
Hospital Mãe de Deus
Porto Alegre, Rio Grande do Sul, 90880-480
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, 91350-200
Universidade Federal de São Paulo - Hospital São Paulo
São Paulo, São Paulo, 04023-900
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05651-901
United States3 sites
Indiana Cancer Center
Indianapolis, Indiana, 46202
Norton Healthcare Cancer Center
Louisville, Kentucky, 40202
Arizona Cancer Center
Tucson, Arizona, 85724
About this study
Official title: A Phase 1/2 Dose-Escalation Study of the Safety, Efficacy and Pharmacokinetics of Glufosfamide in Combination With Gemcitabine in Advanced Solid Tumors and Pancreatic Adenocarcinoma
The purpose of this study is to determine the safety of glufosfamide when administered in combination with gemcitabine.
Read the detailed description
This study, TH-CR-301, is a Phase 1/2 study that will evaluate the efficacy and safety of glufosfamide in combination with gemcitabine in advanced solid tumors or in first line treatment of pancreatic cancer.
Study Hypothesis: Glufosfamide in combination with gemcitabine may provide benefits in survival to patients with advanced solid tumors or metastatic pancreatic cancer.
- Conditions
- Neoplasms, Pancreatic Neoplasms
- Being tested
- Glufosfamide, Gemcitabine
- Keywords
- Pancreas, Cancer, Metastatic, Glufosfamide, Advanced, Solid, Tumor, Advanced Solid Tumors, Pancreatic Adenocarcinoma
- Medical subject headings
- Neoplasms, Pancreatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlufosfamideDrug
GemcitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall objective response rate
Secondary outcomes (5)
Overall survival
6- and 12- month survival
Progression-free survival
Duration of objective response
Serum CA-19-9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2005 (estimated)
- Study startDec 2004
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants
Sponsor and investigators
- Lead sponsor
- Threshold Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102752
- Sponsor's protocol ID
- TH-CR-301
- Status last verified
- Apr 2009
- First submitted
- 1 Feb 2005
- Last updated
- 30 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Dose-Escalation Study of the Safety, Efficacy and Pharmacokinetics of Glufosfamide in Combination With Gemcitabine in Advanced Solid Tumors and Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00102752
- Acronym / sponsor ID
- TH-CR-301
- Conditions
- Neoplasms, Pancreatic Neoplasms
- Keywords
- Pancreas, Cancer, Metastatic, Glufosfamide, Advanced, Solid, Tumor, Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants
- Lead sponsor
- Threshold PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- Dec 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 2 Feb 2005 (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.
The purpose of this study is to determine the safety of glufosfamide when administered in combination with gemcitabine.
Detailed description
This study, TH-CR-301, is a Phase 1/2 study that will evaluate the efficacy and safety of glufosfamide in combination with gemcitabine in advanced solid tumors or in first line treatment of pancreatic cancer.
Study Hypothesis: Glufosfamide in combination with gemcitabine may provide benefits in survival to patients with advanced solid tumors or metastatic pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least 18 years of age
- Histologically or cytologically confirmed, locally advanced or metastatic solid malignancy; previously treated with at least one chemotherapy regimen for advanced or metastatic disease or no effective standard treatment is available OR
- Metastatic and/or locally advanced, inoperable pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided)
- Measurable or nonmeasurable disease by RECIST criteria (at least one target or nontarget lesion)
- Recovered from reversible toxicities of prior therapy
Key exclusion criteria (22 listed)
- Prior chemotherapy for metastatic/locally advanced pancreatic cancer
- Prior administration of gemcitabine
- Radiation therapy within 28 days prior to study start
- Hormonal therapy, biologic therapy, chemotherapy or other systemic anti-tumor therapy for cancer within 21 days prior to study start
- Symptomatic brain metastases (baseline CT scan is not required in asymptomatic subjects)
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 | – |
| Gemcitabine | Drug | – |
Primary outcome
Overall objective response rate
5 secondary outcomes
Overall survival
6- and 12- month survival
Progression-free survival
Duration of objective response
Serum CA-19-9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Glufosfamide and Gemcitabine in people with Neoplasms and Pancreatic Neoplasms, run by Threshold Pharmaceuticals at 9 sites in 2 countries.
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 8 inclusion and 22 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: finished, as of the sponsor's last update on 30 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Brazil, 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall objective response rate. 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 30 Apr 2009.