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Phase I/II Study of a Triplet Combination of CBP501, Pemetrexed and Cisplatin in Patients With Advanced Solid Tumors and in Chemotherapy-naïve Patients With Malignant Pleural Mesothelioma

Phase 1/Phase 2
18 Years
Not Enrolling
Malignant Pleural Mesothelioma, Solid Tumors

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Trial Information

Phase I/II Study of a Triplet Combination of CBP501, Pemetrexed and Cisplatin in Patients With Advanced Solid Tumors and in Chemotherapy-naïve Patients With Malignant Pleural Mesothelioma

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

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

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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Ph I: To determine the MTD of CBP501 + pemetrexed + cisplatin in patients with advanced solid tumors. Ph II: To evaluate the efficacy and safety profile of CBP501 + pemetrexed + cisplatin in patients with malignant pleural mesothelioma

Outcome Time Frame:

End of study

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2008

Completion Date:

November 2012

Related Keywords:

  • Malignant Pleural Mesothelioma
  • Solid Tumors
  • malignant pleural mesothelioma
  • solid tumors
  • Mesothelioma
  • Neoplasms



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