Clinical trial NCT00700336 (phase 1/phase 2, status: completed)
Conditions: malignant pleural mesothelioma, solid tumors
ICD codes: C45.9, C45.0, C45.1, C45.2, C45.7
Drugs: pemetrexed, cisplatin and cbp501, pemetrexed and cisplatin
SMILES: [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H], [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent obtained prior to initiation of any study-specific procedures

          2. Phase I: Histologically confirmed solid malignancy that is metastatic or unresectable
             and for which standard curative or palliative measures do not exist or are no longer
             effective or would otherwise be eligible for cisplatin and pemetrexed as first-line
             therapy

             Phase II: Histologically or cytologically confirmed diagnosis of malignant pleural
             mesothelioma (MPM), not amenable for radical resection, who has not received previous
             chemotherapy or other systemic treatment

          3. Measurable disease according to the modified Response Evaluation Criteria in Solid
             Tumors (RECIST, see below)

          4. Male or female patients aged at least 18 years

          5. ECOG Performance Status (PS): 0-2

          6. Previous anticancer treatment must be discontinued at least 3 weeks prior to first
             dose of study treatment (6 weeks for mitomycin C; 6 weeks for anti-androgen therapy if
             discontinued prior to treatment initiation, with the exception of 8 weeks for
             bicalutamide)

          7. Life expectancy greater than 3 months

          8. Adequate organ function

          9. Female patients of child-bearing potential must have a negative pregnancy test and be
             using at least one form of contraception as approved by the Investigator for 4 weeks
             prior to the study and 4 months after the last dose of study drug. For the purposes of
             this study, child-bearing potential is defined as: "All female patients unless they
             are post-menopausal for at least one year or are surgically sterile"

         10. Male patients must use a form of barrier contraception approved by the investigator
             during the study and for 4 months after the last dose of study drug

         11. Ability to cooperate with the treatment and follow-up

        Exclusion Criteria:

          1. Radiation therapy to more than 30% of the bone marrow prior to entry into the study

          2. Phase II only: Mesothelioma originating outside the pleura (e.g.: peritoneum)

          3. Absence of measurable lesions

          4. The patient has an ongoing or active infection, symptomatic congestive heart failure,
             unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia,
             uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled
             medical disorders in the opinion of the investigator.

          5. Any previous history of another malignancy within 5 years of study entry (other than
             cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix)

          6. Presence of any significant central nervous system or psychiatric disorder(s) that
             would hamper the patient's compliance

          7. Evidence of peripheral neuropathy > grade 1 according to NCI-CTCAE Version 3

          8. Treatment with any other investigational agent, or participation in another clinical
             trial within 28 days prior to study entry

          9. Pregnant or breast-feeding patients or any patient with childbearing potential not
             using adequate contraception

         10. Known HIV, HBV, HCV infection

         11. Presence of CNS metastases