Status:
TERMINATED
A Phase I Study of Zalypsis (PM00104) in Subjects With Advanced Malignant Solid Tumors or Lymphoma
Lead Sponsor:
PharmaMar
Conditions:
Solid Tumors
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Phase I trial, dose escalating, prospective, open-label, non-randomized, multicenter study. The purpose is to determine the safety, tolerability, dose limiting toxicity (DLT) and recommended dose (RD)...
Detailed Description
Phase I trial, dose escalating, prospective, open-label, non-randomized, multicenter study. The purpose is to determine the safety, tolerability, dose limiting toxicity (DLT) and recommended dose (RD)...
Eligibility Criteria
Inclusion
- Voluntary written informed consent of the subject obtained before any study-specific procedure.
- Histologically or cytologically confirmed malignant solid tumor or lymphoma.
- Subjects with malignancies that are not otherwise curable or for which no effective standard therapy exists.
- Age ≥ 18 years.
- Subject with measurable or non-measurable disease using the RECIST criteria
- Recovery from any drug-related adverse event related to previous treatment, excluding alopecia and NCI-CTCAE grade \< 2 peripheral neuropathy.
- Laboratory values within 7 days prior to first infusion:
- Platelet count ≥ 100 x109/L, hemoglobin ≥ 9 g/dL and absolute neutrophil count (ANC) ≥ 1.5 x109/L.
- Alkaline phosphatase ≤ 2.5 x the upper limit of normal (ULN) (≤ 5 x ULN in case of extensive bone metastases)
- Aspartate aminotransferase (AST): ≤ 2.5 x ULN
- Alanine aminotransferase (ALT): ≤ 2.5 x ULN
- Total bilirubin: ≤ 1.5 ULN, unless due to Gilbert's syndrome.
- Creatinine: ≤ ULN, or calculated creatinine clearance: ≥ 60 mL/min (calculated from the Cockcroft-Gault formula; see Appendix III).
- Albumin: ≥ 2.5 g/dL.
- Partial thromboplastin within normal limits for the institution
- International normalized ratio (INR) within normal limits for the institution (unless due to oral anticoagulation)
- Performance status (ECOG) ≤ 1
- Life expectancy ≥ 3 months.
- Left ventricular ejection fraction (LVEF) within normal limits for the institution (LVEF of at least 50%).
- Women of childbearing potential must have a negative serum pregnancy test before study entry. Both men and women must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of treatment. Acceptable methods of contraception include complete abstinence, Intrauterine device, oral contraceptive, subdermal implant and double barrier (condom with a contraceptive sponge or contraceptive suppository).
Exclusion
- Prior therapy with PM00104
- Pregnant or lactating women.
- Less than 4 weeks from radiation therapy (8 weeks in case of extensive prior radiotherapy) or last dose of hormonal therapy, biological therapy or chemotherapy (6 weeks in case of nitrosourea, mitomycin C).
- Prior high dose chemotherapy that needed bone marrow transplant support.
- Subjects with untreated or uncontrolled brain or meningeal metastases.
- Other relevant diseases or adverse clinical conditions:
- Increased cardiac risk as defined by:
- History or presence of unstable angina.
- History or presence of myocardial infarction.
- Congestive heart failure.
- Symptomatic arrhythmia or any arrhythmia requiring ongoing treatment.
- Abnormal ECG (i.e., patients with the following are excluded: QT prolongation-corrected QT interval \> 480 msec-, signs of cardiac enlargement or hypertrophy, bundle branch block, partial bundle branch blocks, signs of ischemia or necrosis, Wolff-Parkinson-White patterns).
- History or presence of valvular heart disease.
- Uncontrolled arterial hypertension despite optimal medical therapy.
- Previous mediastinal radiotherapy.
- Previous treatment with doxorubicin at cumulative doses in excess of 400 mg/m2
- History of significant neurological or psychiatric disorders.
- Active infection.
- Significant non-neoplastic liver disease (e.g., cirrhosis, chronic active hepatitis).
- Significant non-neoplastic renal disease.
- Immunocompromised subjects, including subjects known to be infected by human immunodeficiency virus (HIV).
- Uncontrolled endocrine diseases (e.g., diabetes mellitus, hypothyroidism or hyperthyroidism, adrenal disorder) requiring relevant changes in medication within the last month or hospital admission within the last 3 months.
- Any other major illness that, in the investigator's judgment, could substantially increase the risk associated with the subject's participation in this study.
- Limitation of the subject's ability to comply with the treatment or to follow-up at a participating center. Subjects registered on this trial must be treated and followed at a participating center.
- Treatment with any investigational product in the 30 days period prior to the first infusion.
- Known hypersensitivity to any of the components of the drug product, including sucrose or potassium phosphate.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00359294
Start Date
May 1 2006
End Date
September 1 2008
Last Update
July 28 2021
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
2
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497