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Advanced CancerPhase 1NCT00741403

A Open Label Phase I/II Clinical Trial to Evaluate CPI-613 in Patients With Advanced Malignancies

A Phase 1 study testing CPI-613 in people with Advanced Cancer and Metastatic Cancer, run by Cornerstone Pharmaceuticals at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

An open label, dose-escalation study to evaluate safety, tolerability, maximum tolerated dose (MTD), efficacy, and pharmacokinetics (PKs) of CPI-613 given twice weekly for three consecutive weeks in cancer patients The objectives of this study are: To determine the safety and MTD of CPI-613 when administered 2x weekly… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer, Metastatic Cancer, Lymphoma
What is being tested?
CPI-613
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
4 sitesin 2 countries
Study dates
Aug 2008to Dec 2016
Phase
Phase 1
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

  • Patients must have advanced and/or metastatic, histologically or cytologically documented solid tumors and lymphomas, for whom there is no available therapy shown to provide clinical benefit.
  • Karnofsky Performance Status (KPS) of >70%.
  • Must be ≥18 years of age.
  • Expected survival >3 months.
  • 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), 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 period, unless documentation of infertility exists.
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  • Mentally competent, ability to understand and willingness to sign the informed consent form.
  • No radiotherapy, treatment with cytotoxic agents (except CPI-613), or treatment with biologic agents within the 3 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 ≥100,000 cells/mm^3 or ≥100 bil/L; absolute neutrophil count [ANC] ≥1500 cells/mm^3 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).
  • Adequate coagulation (International Normalized Ratio or INR must be ≤1.25).

Who cannot join

  • Serious medical illness, such as significant cardiac disease (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 because the potential of excretion of CPI-613 into breast milk. (Note: Lactating females are excluded because the effects of CPI-613 on a nursing child are unknown.)
  • Fertile men unwilling to practice contraceptive methods during the study period.
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  • Life expectancy less than 3 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 and recurrent pleural, or peritoneal effusions requiring frequent drainage (e.g. weekly). Patients with any amount of clinically significant pericardial effusion.
  • 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 3 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., clinically significant heart failure, hypokalemia, family history of Long QT Syndrome).
  • Troponin I above institution limit of normal or Left Ventricular Ejection Fraction (LVEF) below 35%.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United States3 sites

  • Mary Crowley Cancer Research Centers

    Dallas, Texas, 75201

  • Pivotal Research Centers

    Peoria, Arizona, 85381

  • Eastchester Center for Cancer Care

    The Bronx, New York, 10469

Other trials in United States

Canada1 site

  • British Columbia Cancer Agency

    Vancouver, British Columbia

Other trials in Canada

About this study

Official title: An Open Label, Dose-Escalation Study to Evaluate Safety, Tolerability, Maximum Tolerated Dose (MTD), Efficacy, and Pharmacokinetics (PKs) of CPI-613 Given Twice Weekly for Three Consecutive Weeks in Cancer Patients

An open label, dose-escalation study to evaluate safety, tolerability, maximum tolerated dose (MTD), efficacy, and pharmacokinetics (PKs) of CPI-613 given twice weekly for three consecutive weeks in cancer patients

The objectives of this study are:

  • To determine the safety and MTD of CPI-613 when administered 2x weekly for 3 consecutive weeks.
  • To determine pharmacokinetics of CPI-613 following intravenous (IV) administration.
  • To observe the anti-tumor effects of CPI-613, if any occur.
Being tested
CPI-613
Keywords
Phase I, malignancies, refractory, relapsed
Medical subject headings
Neoplasm Metastasis, Lymphoma, Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CPI-613Drug

    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 groups in NCT00741403
Study groupRoleWhat they receive
AExperimentalIV Infusion of CPI-613 on Days 1,4,8,11,15,18 of 28 day cycle in patients with advanced malignancies
Receives: Drug: CPI-613

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the safety, tolerability, maximum tolerated dose (MTD), and efficacy pharmacokinetics of CPI-613 given twice weekly for three consecutive weeks in cancer patients

    Measured: October 2010

Secondary outcomes (1)

  1. To evaluate pharmacokinetics, toxicity profile, biological activity, and anti-tumor activity of CPI-613 given twice weekly for three consecutive weeks in cancer patients

    Measured: October 2010

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00741403
Sponsor's protocol ID
CL-CPI-613-002
Status last verified
Dec 2016
First submitted
25 Aug 2008
Last updated
29 Dec 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CPI-613 in people with Advanced Cancer and Metastatic Cancer, run by Cornerstone Pharmaceuticals at 4 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 13 inclusion and 21 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 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Canada. 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 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.

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?

To evaluate the safety, tolerability, maximum tolerated dose (MTD), and efficacy pharmacokinetics of CPI-613 given twice weekly for three consecutive weeks in cancer patients (time frame: October 2010). 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 NCT00741403.

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 29 Dec 2016.

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