CancerPhase 1/2NCT00907166
A Phase I/II Open-Label Dose-Escalation Clinical Trial of CPI-613 in Combination With Gemcitabine in Cancer Patients
A Phase 1/2 study testing CPI-613 and Gemcitabine in people with Cancer and Pancreatic Cancer, run by Cornerstone Pharmaceuticals at 2 sites in United States.
Trial summary
The objectives of this study are: To determine the safety and MTD of CPI-613, when used in combination with Gemcitabine, in cancer patients. To compare the safety and efficacy of CPI-613/Gemcitabine combination vs. Gemcitabine alone in patients with carcinoma of the pancreas. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cancer, Pancreatic Cancer, Pancreatic Carcinoma
- What is being tested?
- CPI-613 and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2009to Dec 2017
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Stages 1 and 2 of the study, histologically documented unresectable primary or metastatic carcinoma of the pancreas, Stage II-IV, diagnosed within the past 8 weeks, intended to be treated with Gemcitabine as a single agent at 1000 mg/m^2 once weekly for 3 weeks repeating the cycle every 4 weeks. For Stage 1 but not Stage 2 of the study, patients also include those with histologically documented unresectable primary or metastatic carcinoma other than pancreatic carcinoma (e.g., bladder cancer, NSCLC, and biliary tract cancer) who are intended to be treated with Gemcitabine as a single agent at 1000 mg/m^2 once weekly for 3 weeks repeating the cycle every 4 weeks, regardless if Gemcitabine is used as second, third or fourth line treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status being 0-2.
- Expected survival >2 months.
- 18-70 years of age of both genders
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation.
- Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists.
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- No radiotherapy, treatment with cytotoxic agents or chemotherapeutic agents (except CPI-613), or treatment with biologic agents within the 2 weeks prior to treatment with CPI-613. At least 2 weeks must have elapsed from any prior surgery or hormonal therapy. Patients must have fully recovered from the acute toxicities of any prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities (returned to baseline status as noted before most recent treatment). Patients with persisting, stable chronic toxicities from prior treatment ≤Grade 1 are eligible, but must be documented as such.
- Laboratory values ≤2 weeks must be:
- Adequate hematologic (white blood cell [WBC] ≥3500 cells/mm^3 or ≥3.5 bil/L; platelet count ≥150,000 cells/mm^3 or ≥150 bil/L; absolute neutrophil count [ANC] ≥1500 cells/mm3 or ≥1.5 bil/L; and hemoglobin ≥9 g/dL or ≥90 g/L).
- Adequate hepatic function (aspartate aminotransferase [AST/SGOT] ≤3x upper normal limit [UNL], alanine aminotransferase [ALT/SGPT] ≤3x UNL (≤5x UNL if liver metastases present), bilirubin ≤3x UNL).
- Adequate renal function (serum creatinine ≤2.0 mg/dL or 177 µmol/L).
- Adequate coagulation (International Normalized Ratio or INR must be≤1.5)
- No evidence of active infection and no serious infection within the past month.
- Mentally competent, ability to understand and willingness to sign the informed consent form.
Who cannot join
- Prior therapy with Gemcitabine
- Serious medical illness, such as significant cardiac disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or New York Heart Association Class III or IV), or severe debilitating pulmonary disease, that would potentially increase patients' risk for toxicity.
- Patients with active central nervous system (CNS) or epidural tumor.
- Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease).
- Pregnant women, or women of child-bearing potential not using reliable means of contraception (because the teratogenic potential of CPI-613 is unknown).
- Lactating females.
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- Fertile men unwilling to practice contraceptive methods during the study period.
- Life expectancy less than 2 months.
- Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients.
- Unwilling or unable to follow protocol requirements.
- Dyspnea with minimal to moderate exertion. Patients with large pleural, pericardial, or peritoneal effusions.
- Active heart disease including myocardial infarction within previous 6 months, symptomatic coronary artery disease, arrhythmias requiring medication, or symptomatic congestive heart failure.
- Albumin <2.5 g/dL or <25 g/L.
- Evidence of active infection, or serious infection within the past month.
- Patients with known HIV infection.
- Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 4 weeks prior to initiation of CPI-613 treatment.
- Patients who have received immunotherapy of any type within the past 4 weeks prior to initiation of CPI-613 treatment.
- Requirement for immediate palliative treatment of any kind including surgery.
- Patients that have received a chemotherapy regimen with stem cell support in the previous 6 months.
- A marked baseline prolongation of QT/QTc interval (e.g., repeated exhibition of a QTc interval >470 ms.)
- A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- Prior illicit drug addiction.
- Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mary Crowley Cancer Research Centers
Dallas, Texas, 75201
Eastchester Center for Cancer Care
The Bronx, New York, 10469
About this study
The objectives of this study are:
- To determine the safety and MTD of CPI-613, when used in combination with Gemcitabine, in cancer patients.
- To compare the safety and efficacy of CPI-613/Gemcitabine combination vs. Gemcitabine alone in patients with carcinoma of the pancreas.
Read the detailed description
CPI-613, the investigational drug, is a novel anti-tumor compound believed to operate via a novel mechanism of action that does not belong to any existing pharmacological class of anticancer agents currently being used in the clinics. Specifically, CPI-613 is Cornerstone Pharmaceutical Inc.'s lead drug from its Altered Energy Metabolism-Directed (AEMD) technology platform. It is selective against tumor cells (but not normal cells)according to preclinical studies.
- Conditions
- Cancer, Pancreatic Cancer, Pancreatic Carcinoma
- Being tested
- CPI-613, Gemcitabine
- Keywords
- Cornerstone Pharmaceuticals, Inc., CPI-613, Altered Energy Metabolism Directed Compound, Phase I, Phase II, Cancer, Carcinoma of the Pancreas, Pancreatic Cancer, Pancreatic Carcinoma
- Medical subject headings
- Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPI-613Drug
IV infusion of CPI-613 given on Days 1,4, 8, 11, 15, 18, of 28 day cycle in cancer patients.
CPI-613Drug
IV infusion of CPI-613 given on Days 1, 4, 8, 11, 15, 18, of 28 day cycle in patients with pancreatic carcinoma.
GemcitabineDrug
IV infusion of 1000 mg/m^2 of Gemcitabine given on Days 1, 8, and 15 of a 28 day cycle in patients with pancreatic carcinoma.
GemcitabineDrug
IV infusion of 1000 mg/m^2 of Gemcitabine given on Days 1, 8, and 15 of a 28 day cycle in cancer patients.
GemcitabineDrug
IV infusion of 1000 mg/m^2 of Gemcitabine given on Days 1, 8, and 15 of a 28 day cycle in patients with pancreatic carcinoma.
| Study group | Role | What they receive |
|---|---|---|
| Phase I, Arm A | Experimental | CPI-613 + Gemcitabine Receives: Drug: CPI-613; Drug: Gemcitabine |
| Phase II, Arm A | Experimental | CPI-613 + Gemcitabine Receives: Drug: CPI-613; Drug: Gemcitabine |
| Phase II, Arm B | Active comparator | Gemcitabine Receives: Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and MTD of CPI-613, when used in combination with Gemcitabine, in cancer patients.
Measured: 1 Year
Secondary outcomes (1)
To compare the safety and efficacy of CPI-613 Gemcitabine combination vs. Gemcitabine alone in patients with carcinoma of the pancreas.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Suspended trial was not restarted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornerstone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Avi Retter, M.D., Principal investigator, Eastchester Center for Cancer CareNeil Senzer, M.D., Principal investigator, Mary Crowley Cancer Research Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907166
- Sponsor's protocol ID
- CL-CPI-613-004
- Status last verified
- Jan 2017
- First submitted
- 21 May 2009
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Open-Label Dose-Escalation Clinical Trial of CPI-613 in Combination With Gemcitabine in Cancer Patients
- ClinicalTrials.gov ID
- NCT00907166
- Acronym / sponsor ID
- CL-CPI-613-004
- Conditions
- Cancer, Pancreatic Cancer, Pancreatic Carcinoma
- Keywords
- Cornerstone Pharmaceuticals, Inc., CPI-613, Altered Energy Metabolism Directed Compound, Phase I, Phase II, Cancer, Carcinoma of the Pancreas, Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Suspended trial was not restarted.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Cornerstone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 22 May 2009 (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 objectives of this study are:
- To determine the safety and MTD of CPI-613, when used in combination with Gemcitabine, in cancer patients.
- To compare the safety and efficacy of CPI-613/Gemcitabine combination vs. Gemcitabine alone in patients with carcinoma of the pancreas.
Detailed description
CPI-613, the investigational drug, is a novel anti-tumor compound believed to operate via a novel mechanism of action that does not belong to any existing pharmacological class of anticancer agents currently being used in the clinics. Specifically, CPI-613 is Cornerstone Pharmaceutical Inc.'s lead drug from its Altered Energy Metabolism-Directed (AEMD) technology platform. It is selective against tumor cells (but not normal cells)according to preclinical studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I, Arm A | Experimental | Drug: CPI-613, Drug: GemcitabineCPI-613 + Gemcitabine |
| Phase II, Arm A | Experimental | Drug: CPI-613, Drug: GemcitabineCPI-613 + Gemcitabine |
| Phase II, Arm B | Active comparator | Drug: GemcitabineGemcitabine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- For Stages 1 and 2 of the study, histologically documented unresectable primary or metastatic carcinoma of the pancreas, Stage II-IV, diagnosed within the past 8 weeks, intended to be treated with Gemcitabine as a single agent at 1000 mg/m^2 once weekly for 3 weeks repeating the cycle every 4 weeks. For Stage 1 but not Stage 2 of the study, patients also include those with histologically documented unresectable primary or metastatic carcinoma other than pancreatic carcinoma (e.g., bladder cancer, NSCLC, and biliary tract cancer) who are intended to be treated with Gemcitabine as a single agent at 1000 mg/m^2 once weekly for 3 weeks repeating the cycle every 4 weeks, regardless if Gemcitabine is used as second, third or fourth line treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status being 0-2.
- Expected survival >2 months.
- 18-70 years of age of both genders
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation.
Key exclusion criteria (23 listed)
- Prior therapy with Gemcitabine
- Serious medical illness, such as significant cardiac disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or New York Heart Association Class III or IV), or severe debilitating pulmonary disease, that would potentially increase patients' risk for toxicity.
- Patients with active central nervous system (CNS) or epidural tumor.
- Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease).
- Pregnant women, or women of child-bearing potential not using reliable means of contraception (because the teratogenic potential of CPI-613 is unknown).
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 |
|---|---|---|
| CPI-613IV infusion of CPI-613 given on Days 1,4, 8, 11, 15, 18, of 28 day cycle in cancer patients. | Drug | Phase I, Arm A |
| CPI-613IV infusion of CPI-613 given on Days 1, 4, 8, 11, 15, 18, of 28 day cycle in patients with pancreatic carcinoma. | Drug | Phase II, Arm A |
| GemcitabineIV infusion of 1000 mg/m^2 of Gemcitabine given on Days 1, 8, and 15 of a 28 day cycle in patients with pancreatic carcinoma. | Drug | Phase II, Arm B |
| GemcitabineIV infusion of 1000 mg/m^2 of Gemcitabine given on Days 1, 8, and 15 of a 28 day cycle in cancer patients. | Drug | Phase I, Arm A |
| GemcitabineIV infusion of 1000 mg/m^2 of Gemcitabine given on Days 1, 8, and 15 of a 28 day cycle in patients with pancreatic carcinoma. | Drug | Phase II, Arm A |
Primary outcome
To determine the safety and MTD of CPI-613, when used in combination with Gemcitabine, in cancer patients.
Time frame: 1 Year
1 secondary outcome
To compare the safety and efficacy of CPI-613 Gemcitabine combination vs. Gemcitabine alone in patients with carcinoma of the pancreas.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Suspended trial was not restarted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
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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.
Avi Retter, M.D. principal investigator
Eastchester Center for Cancer Care
Neil Senzer, M.D. principal investigator
Mary Crowley Cancer Research Centers
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CPI-613 and Gemcitabine in people with Cancer and Pancreatic Cancer, run by Cornerstone Pharmaceuticals at 2 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 14 inclusion and 23 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 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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 was stopped early (reason given: Suspended trial was not restarted.). Results are not available in the source record.
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 determine the safety and MTD of CPI-613, when used in combination with Gemcitabine, in cancer patients. (time frame: 1 Year). 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 21 Mar 2017.