A Phase I Study of Zalypsis (PM00104) in Subjects With Advanced Malignant Solid Tumors or Lymphoma

Stopped early · Phase 1

Conditions studied: Solid Tumors, Lymphoma

In brief

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) of PM00104, administered intravenously over 1 hour daily for 5 days every 3 weeks (this is considered as 1 cycle) to subjects with advanced malignant solid tumors or lymphoma.

Key facts

Study ID

NCT00359294

Run by

PharmaMar

People needed

12

Starts

2006-05-01

Expected to finish

2008-09-01

Last updated by the study team

2021-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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