Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00741403
Other study ID # CL-CPI-613-002
Secondary ID
Status Completed
Phase Phase 1
First received August 25, 2008
Last updated December 28, 2016
Start date August 2008
Est. completion date December 2016

Study information

Verified date December 2016
Source Cornerstone Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health Canada
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

- 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).

Exclusion Criteria:

- 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.

- 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%.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
CPI-613
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

Locations

Country Name City State
Canada British Columbia Cancer Agency Vancouver British Columbia
United States Eastchester Center for Cancer Care Bronx New York
United States Mary Crowley Cancer Research Centers Dallas Texas
United States Pivotal Research Centers Peoria Arizona

Sponsors (1)

Lead Sponsor Collaborator
Cornerstone Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 October 2010 Yes
Secondary To evaluate pharmacokinetics, toxicity profile, biological activity, and anti-tumor activity of CPI-613 given twice weekly for three consecutive weeks in cancer patients October 2010 Yes
See also
  Status Clinical Trial Phase
Recruiting NCT05540340 - A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant Phase 1
Completed NCT01947140 - Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies Phase 1/Phase 2
Completed NCT00001512 - Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines Phase 1
Recruiting NCT05618041 - The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies N/A
Completed NCT01410630 - FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma
Active, not recruiting NCT04270266 - Mind-Body Medicine for the Improvement of Quality of Life in Adolescents and Young Adults Coping With Lymphoma N/A
Terminated NCT00801931 - Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders Phase 1/Phase 2
Completed NCT01949883 - A Phase 1 Study Evaluating CPI-0610 in Patients With Progressive Lymphoma Phase 1
Completed NCT01682226 - Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies Phase 2
Completed NCT00003270 - Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer Phase 2
Recruiting NCT04904588 - HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide Phase 2
Recruiting NCT05019976 - Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma N/A
Completed NCT04434937 - Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213) Phase 2
Completed NCT01855750 - A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma Phase 3
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Terminated NCT00775268 - 18F- Fluorothymidine to Evaluate Treatment Response in Lymphoma Phase 1/Phase 2
Active, not recruiting NCT04188678 - Resiliency in Older Adults Undergoing Bone Marrow Transplant N/A
Terminated NCT00014560 - Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Phase 1
Recruiting NCT04977024 - SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer Phase 2
Active, not recruiting NCT03936465 - Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitors BMS-986158 and BMS-986378 in Pediatric Cancer Phase 1