Study of the Combination of Tivantinib Plus Pemetrexed and Carboplatin

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, open-label, mono-centric, phase I-Ib trial of Tivantinib in combination with Pemetrexed and Carboplatin as first-line therapy in patients with advanced or metastatic cancer suitable for a Carboplatin and Pemetrexed regimen as part of their specific therapy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Armando Santoro, MD
• Treatments: Carboplatin; Pemetrexed

Criteria

Inclusion Criteria:

1. Patients must be diagnosed with MPM or non squamous NSCLC.

2. Inoperable disease according to local surgeon, not previously treated with chemotherapy; patients relapsed/progressed after previous surgery will be also evaluable for inclusion.

3. Age > 18.

4. ECOG Performance Status 0-1 and life expectancy of at least 12 weeks.

5. Measurable and/or evaluable lesions according to modified RECIST criteria [51].

6. Written informed consent.

7. Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating center.

8. Patients must use effective contraception during the study lasting at least one month after the end of treatment for both sexes.

9. Laboratory requirements:

• Neutrophils >1.5 x 109/L and Platelets >100 x 109/L

• Total bilirubin <1.5 time the upper-normal limits (UNL) of the Institutional normal values, AST (SGOT) and ALT (SGPT) < 2.5 x UNL, or <5 x UNL in case of liver metastases, alkaline phosphatase <2.5 x UNL, < 5 x UNL in case of liver metastases, <10 x UNL in case of bone metastases.

• Creatinine clearance >50 mL/min

Exclusion Criteria:

1. Any prior chemotherapy (including intracavitary administration).

2. Symptomatic and/or unstable pre-existing brain metastases.To be enrolled in the study , subjects must have confirmation of stable disease by MRI or computer tomography (CT) scan within 4 weeks from day 1 of cycle 1 of treatment and have CNS metastases well controlled by steroids, anti - epileptics or other symptom-relieving medications

3. Serious non-healing wound or ulcer.

4. Evidence of bleeding diathesis or coagulopathy.

5. Uncontrolled hypertension.

6. Clinically significant (i.e. active) cardiovascular disease, for example cerebrovascular accidents (<6 months), myocardial infarction (< 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication.

7. Current treatment with anticoagulants for therapeutic purposes.

8. Treatment with any investigational drug within 30 days prior to enrolment.

9. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ

10. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study.

11. Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.