Metastatic Pancreatic AdenocarcinomaPhase 2NCT01830322
Safety and Effectiveness Study of CPI-613 and/or Gemcitabine to Treat Metastatic Pancreatic Cancer
A Phase 2 study testing CPI-613 and Gemcitabine in people with Metastatic Pancreatic Adenocarcinoma, run by Cornerstone Pharmaceuticals at 2 sites in United States.
Trial summary
This Phase II study is conducted to assess the safety and efficacy of CPI-613 in patients with metastatic pancreatic cancer. The primary outcome measure is Overall Survival (OS). The secondary outcome measures are: changes in CA 19-9, Quality of Life (QOL), Progression-Free Survival (PFS), and safety. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Metastatic Pancreatic Adenocarcinoma
- 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
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2014to Dec 2018
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically and cytologically confirmed, measurable metastatic pancreatic adenocarcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status being 0-2
- Expected survival >2 months
- 18 years of age or older 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. (Note: Pregnant patients are excluded because the effects of CPI-613 on a fetus are unknown.)
- Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists.
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- At least 2 weeks must have elapsed from any prior surgery or hormonal therapy. Must have fully recovered from the acute toxicities of any prior treatment with any anti-cancer 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/mm3 or ≥3.5 bil/L; platelet count ≥150,000 cells/mm3 or ≥150 bil/L; absolute neutrophil count [ANC] ≥1500 cells/mm3 or ≥1.5 bil/L; and hemoglobin (Hgb) ≥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 ≤1.5x UNL).
- Adequate renal function (serum creatinine ≤2.0 mg/dL or 177 μmol/L, and blood urea nitrogen [BUN] ≤25 mg/dL).
- Adequate coagulation ("International Normalized Ratio or INR must be <1.5"), unless treated with anticoagulants.
- No evidence of active infection and no serious infection within the past month; no systemic fungal, bacterial, viral or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment.
- Consent to participating the study by signed informed consent form
Who cannot join
- Serious medical illness that would potentially increase patients' risk for toxicity
- Any active uncontrolled bleeding or patients with a bleeding diathesis (e.g., active peptic ulcer disease)
- Patients with active central nervous system (CNS) or epidural tumor
- Lactating females (Note: Lactating females are excluded because the effects of CPI-613 on a nursing child are unknown)
- Life expectancy less than 2 months
- Unwilling or unable to follow protocol requirements
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- Dyspnea with minimal to moderate exertion, or patients with pleural, pericardial, or peritoneal effusions
- Active heart disease including but not limited to symptomatic congestive heart failure, symptomatic coronary artery disease, symptomatic angina pectoris, symptomatic myocardial infarction, arrhythmias requiring medication, or symptomatic congestive heart failure. Also patients with a history of myocardial infarction that is <1 year prior to registration, or patients with previous congestive heart failure (<1 year prior to registration) requiring pharmacologic support or with Left Ventricular Ejection Fraction <50%).
- 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).
- Requirement for immediate palliative treatment of any kind including surgery
- Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Temple Vasicek Cancer Treatment Center
Temple, Texas, 76508
Eastchester Center for Cancer Care
The Bronx, New York, 10469
About this study
Official title: A Phase II Open-Label Clinical Trial of CPI-613 Given Alone, or in Combination With Gemcitabine, in Patients With Metastatic Pancreatic Cancer
This Phase II study is conducted to assess the safety and efficacy of CPI-613 in patients with metastatic pancreatic cancer. The primary outcome measure is Overall Survival (OS). The secondary outcome measures are: changes in CA 19-9, Quality of Life (QOL), Progression-Free Survival (PFS), and safety.
Read the detailed description
Data from dose-escalated Phase I trials indicate that CPI-613 is safe and effective against metastatic pancreatic cancer (Lee et al. 2012; Retter et al. 2012). Accordingly, this Phase II trial is conducted to assess the safety and efficacy of CPI-613 in patients with metastatic pancreatic cancer.
Primary Outcome Measure:
- Overall Survival (OS)
Secondary Outcome Measures:
- Changes in CA 19-9
- Quality of Life (QOL) assessment
- Progression-Free Survival (PFS)
- Safety
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Being tested
- CPI-613, Gemcitabine, Any non-gemcitabine chemotherapies or best supportive care
- Keywords
- metastatic, pancreatic, adenocarcinoma, cancer
- Medical subject headings
- Neoplasm Metastasis, Adenocarcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPI-613Drug
Also called 6,8-bis-benzylsulfanyloctanoic acid, 6,8-bis(benzylthio)octanoic acid, 6,8-bis-benzylsulfonyloctanoic acid, Bylantra
CPI-613 drug product, provided in concentrated form at 50 mg/mL, must be diluted with D5W prior to administration. CPI-613 is to be infused intravenously (IV) via a central venous catheter. CPI-613 will be given 2x weekly, administered on Days 1 and 4 of each of the 3 treatment weeks, followed by a week of rest. The dose of CPI-613 will be 3,000 mg/m2 infused IV over 2 hours (this is approximate maximum tolerated dosing [MTD]), via a central venous catheter with D5W running at a rate of about 125-150 mL/hr.
GemcitabineDrug
Also called 2´-deoxy-2´,2´-difluorocytidine monohydrochloride (beta-isomer), 4-amino-1-(2-deoxy-2,2-difluoro-β-D-erythro-pentofuranosyl)pyrimidin-2(1H)-on, Gemcitabine HCl, Gemzar
Any non-gemcitabine chemotherapies or best supportive careDrug
| Study group | Role | What they receive |
|---|---|---|
| CPI-613 Alone | Experimental | This arm is for patients that have failed, or are not eligible for, all available therapies INCLUDING gemcitabine-based therapies. CPI-613 drug product, provided in concentrated form at 50 mg/mL, must be diluted with D5W prior to administration. CPI-613 is to be infused intravenously (IV) via a central venous catheter. CPI-613 will be given 2x weekly, administered on Days 1 and 4 of each of the 3 treatment weeks, followed by a week of rest. The dose of CPI-613 will be 3,000 mg/m2 infused IV over 2 hours (this is approximate maximum tolerated dosing [MTD]), via a central venous catheter with D5W running at a rate of about 125-150 mL/hr. Receives: Drug: CPI-613 |
| Any non-gemcitabine chemotherapies or best supportive care | Active comparator | This arm is for patients that have failed, or are not eligible for, all available therapies INCLUDING gemcitabine-based therapies. This arm includes any best-practice standard-of-care chemotherapies deemed appropriate by the clinical investigators, including the option for supportive care, following good clinical practice. Receives: Drug: Any non-gemcitabine chemotherapies or best supportive care |
| Gemcitabine + CPI-613 in combination | Experimental | This arm is for patients who have failed, or are not eligible for, all available therapies EXCEPT gemcitabine-based therapies. When gemcitabine and CPI-613 are administered in combination, gemcitabine will be administered via 30-minute intravenous (IV) infusion at a concentration of 1,000 mg/m2 once-a-week on Day 1 for 3 consecutive weeks, followed by a week-of-rest. CPI-613 will be infused twice a week, administered on Days 1 and 4 for 3 consecutive weeks, followed by a week-of-rest, the same as gemcitabine. The dose of CPI-613 will be 710 mg/m2 infused IV over 2-hours (this is approximate maximum tolerated dosing [MTD] found from Phase I studies in combination with gemcitabine). To note, the dose of CPI-613 may be increased from 710 mg/m2 if ongoing Phase I trial data shows that the MTD of CPI-613 is higher than 710 mg/m2 CPI-613, diluted with D5W. Receives: Drug: CPI-613; Drug: Gemcitabine |
| Gemcitabine alone or in combination with therapeutic agent(s) | Experimental | This arm is for patients who have failed, or are not eligible for, all available therapies EXCEPT gemcitabine-based therapies. Gemcitabine, or Gemcitabine-based, chemotherapy will be administered via 30-minute intravenous (IV) infusion at a concentration of 1,000 mg/m2 once-a-week on Day 1 for 3 consecutive weeks, followed by a week-of-rest. This arm includes any best-practice standard-of-care Gemcitabine-based chemotherapies deemed appropriate by the clinical investigators following good clinical practice. Receives: Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: Monitored until participants pass away, for an expected average of 6 months.
Secondary outcomes (4)
Changes in CA 19-9
CA 19-9 is monitored through blood work ≤2 weeks before treatment and after every third cycle (12 weeks) of treatment while on-study. CA 19-9 is a pancreatic tumor biomarker and a decline in CA 19-9 during and after therapy may be a marker of treatment efficacy.
Measured: Monitored within 2-weeks before treatment, and every 3-cycles (months) during treatment
Quality of Life (QOL)
QOL will be assessed as described by Aaronson NK, et al. 1993. It assesses how the various treatments and the disease affect the daily living abilities of the patient.
Measured: Monitored before, during, and 1-week after treatment with CPI-613, for an expected average of 20 weeks.
Progression-Free Survival (PFS)
Measured: Monitored during treatment with CPI-613 and until participants passed away, which will be an expected average of 6 months.
Safety
Safety assessment will be based on clinical signs, vital signs, blood work, adverse events (AEs), serious adverse events (SAEs), etc.
Measured: Monitored just before study treatment, and during study treatment at the end of every 4-week treatment cycle, for an expected average of 20 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic AdenocarcinomaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornerstone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- King C Lee, Ph.D., Study chair, Cornerstone Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830322
- Sponsor's protocol ID
- CL-CPI-613-024
- Status last verified
- Aug 2013
- First submitted
- 3 Apr 2013
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open-Label Clinical Trial of CPI-613 Given Alone, or in Combination With Gemcitabine, in Patients With Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01830322
- Acronym / sponsor ID
- CL-CPI-613-024
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Keywords
- metastatic, pancreatic, adenocarcinoma, cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cornerstone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 12 Apr 2013 (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 Phase II study is conducted to assess the safety and efficacy of CPI-613 in patients with metastatic pancreatic cancer. The primary outcome measure is Overall Survival (OS). The secondary outcome measures are: changes in CA 19-9, Quality of Life (QOL), Progression-Free Survival (PFS), and safety.
Detailed description
Data from dose-escalated Phase I trials indicate that CPI-613 is safe and effective against metastatic pancreatic cancer (Lee et al. 2012; Retter et al. 2012). Accordingly, this Phase II trial is conducted to assess the safety and efficacy of CPI-613 in patients with metastatic pancreatic cancer.
Primary Outcome Measure:
- Overall Survival (OS)
Secondary Outcome Measures:
- Changes in CA 19-9
- Quality of Life (QOL) assessment
- Progression-Free Survival (PFS)
- Safety
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CPI-613 Alone | Experimental | Drug: CPI-613This arm is for patients that have failed, or are not eligible for, all available therapies INCLUDING gemcitabine-based therapies. CPI-613 drug product, provided in concentrated form at 50 mg/mL, must be diluted with D5W prior to administration. CPI-613 is to be infused intravenously (IV) via a central venous catheter. CPI-613 will be given 2x weekly, administered on Days 1 and 4 of each of the 3 treatment weeks, followed by a week of rest. The dose of CPI-613 will be 3,000 mg/m2 infused IV over 2 hours (this is approximate maximum tolerated dosing [MTD]), via a central venous catheter with D5W running at a rate of about 125-150 mL/hr. |
| Any non-gemcitabine chemotherapies or best supportive care | Active comparator | Drug: Any non-gemcitabine chemotherapies or best supportive careThis arm is for patients that have failed, or are not eligible for, all available therapies INCLUDING gemcitabine-based therapies. This arm includes any best-practice standard-of-care chemotherapies deemed appropriate by the clinical investigators, including the option for supportive care, following good clinical practice. |
| Gemcitabine + CPI-613 in combination | Experimental | Drug: CPI-613, Drug: GemcitabineThis arm is for patients who have failed, or are not eligible for, all available therapies EXCEPT gemcitabine-based therapies. When gemcitabine and CPI-613 are administered in combination, gemcitabine will be administered via 30-minute intravenous (IV) infusion at a concentration of 1,000 mg/m2 once-a-week on Day 1 for 3 consecutive weeks, followed by a week-of-rest. CPI-613 will be infused twice a week, administered on Days 1 and 4 for 3 consecutive weeks, followed by a week-of-rest, the same as gemcitabine. The dose of CPI-613 will be 710 mg/m2 infused IV over 2-hours (this is approximate maximum tolerated dosing [MTD] found from Phase I studies in combination with gemcitabine). To note, the dose of CPI-613 may be increased from 710 mg/m2 if ongoing Phase I trial data shows that the MTD of CPI-613 is higher than 710 mg/m2 CPI-613, diluted with D5W. |
| Gemcitabine alone or in combination with therapeutic agent(s) | Experimental | Drug: GemcitabineThis arm is for patients who have failed, or are not eligible for, all available therapies EXCEPT gemcitabine-based therapies. Gemcitabine, or Gemcitabine-based, chemotherapy will be administered via 30-minute intravenous (IV) infusion at a concentration of 1,000 mg/m2 once-a-week on Day 1 for 3 consecutive weeks, followed by a week-of-rest. This arm includes any best-practice standard-of-care Gemcitabine-based chemotherapies deemed appropriate by the clinical investigators following good clinical practice. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically and cytologically confirmed, measurable metastatic pancreatic adenocarcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status being 0-2
- Expected survival >2 months
- 18 years of age or older 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. (Note: Pregnant patients are excluded because the effects of CPI-613 on a fetus are unknown.)
Key exclusion criteria (11 listed)
- Serious medical illness that would potentially increase patients' risk for toxicity
- Any active uncontrolled bleeding or patients with a bleeding diathesis (e.g., active peptic ulcer disease)
- Patients with active central nervous system (CNS) or epidural tumor
- Lactating females (Note: Lactating females are excluded because the effects of CPI-613 on a nursing child are unknown)
- Life expectancy less than 2 months
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-613Also: 6,8-bis-benzylsulfanyloctanoic acid, 6,8-bis(benzylthio)octanoic acid, 6,8-bis-benzylsulfonyloctanoic acid, BylantraCPI-613 drug product, provided in concentrated form at 50 mg/mL, must be diluted with D5W prior to administration. CPI-613 is to be infused intravenously (IV) via a central venous catheter. CPI-613 will be given 2x weekly, administered on Days 1 and 4 of each of the 3 treatment weeks, followed by a week of rest. The dose of CPI-613 will be 3,000 mg/m2 infused IV over 2 hours (this is approximate maximum tolerated dosing [MTD]), via a central venous catheter with D5W running at a rate of about 125-150 mL/hr. | Drug | CPI-613 Alone, Gemcitabine + CPI-613 in combination |
| GemcitabineAlso: 2´-deoxy-2´,2´-difluorocytidine monohydrochloride (beta-isomer), 4-amino-1-(2-deoxy-2,2-difluoro-β-D-erythro-pentofuranosyl)pyrimidin-2(1H)-on, Gemcitabine HCl, Gemzar | Drug | Gemcitabine + CPI-613 in combination, Gemcitabine alone or in combination with therapeutic agent(s) |
| Any non-gemcitabine chemotherapies or best supportive care | Drug | Any non-gemcitabine chemotherapies or best supportive care |
Primary outcome
Overall Survival (OS)
Time frame: Monitored until participants pass away, for an expected average of 6 months.
4 secondary outcomes
Changes in CA 19-9
Time frame: Monitored within 2-weeks before treatment, and every 3-cycles (months) during treatment
Quality of Life (QOL)
Time frame: Monitored before, during, and 1-week after treatment with CPI-613, for an expected average of 20 weeks.
Progression-Free Survival (PFS)
Time frame: Monitored during treatment with CPI-613 and until participants passed away, which will be an expected average of 6 months.
Safety
Time frame: Monitored just before study treatment, and during study treatment at the end of every 4-week treatment cycle, for an expected average of 20 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 14 Aug 2013.
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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.
King C Lee, Ph.D. study chair
Cornerstone Pharmaceuticals
2 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 CPI-613 and Gemcitabine in people with Metastatic Pancreatic Adenocarcinoma, 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 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: withdrawn, as of the sponsor's last update on 14 Aug 2013. 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 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?
Overall Survival (OS) (time frame: Monitored until participants pass away, for an expected average of 6 months.). 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 14 Aug 2013.