Brief Title
Study of CBP501 + Pemetrexed + Cisplatin on MPM (Phase I/II)
Official Title
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
Brief Summary
The phase I part of the study is a dose-finding study of escalating doses of CBP501 combined
with full-dose cisplatin and pemetrexed in patients with 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. The maximum tolerated dose (MTD) will be determined
based on DLTs occurring during the first treatment cycle. Pharmacokinetics of the triplet
combination will be assessed during the phase I part of the trial.
The phase II part will evaluate full-dose cisplatin and pemetrexed combined with CBP501 (at
the MTD determined in the phase I part) in previously untreated, unresectable malignant
pleural mesothelioma patients. Patients will be randomized in a 2 : 1 ratio to pemetrexed,
cisplatin and CBP501 (Arm A) or to pemetrexed and cisplatin (Arm B); randomization will be
stratified according to histology and performance status.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
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
Secondary Outcome
Ph I: To determine the recommended CBP501 dose for exploration in the phase II part
Condition
Malignant Pleural Mesothelioma
Intervention
pemetrexed, cisplatin and CBP501
Study Arms / Comparison Groups
Arm A
Description: pemetrexed, cisplatin and CBP501
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
71
Start Date
May 2008
Completion Date
November 2012
Primary Completion Date
July 2012
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00700336
Organization ID
CBP08-01
Responsible Party
Sponsor
Study Sponsor
CanBas Co. Ltd.
Study Sponsor
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Verification Date
October 2011