Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
27 participants
INTERVENTIONAL
2008-02-29
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Satraplatin in combo with vinorelbine
Escalating doses of satraplatin and oral vinorelbine in subsequent cohorts of 3-6 patients according to the type and severity grade of acute toxicities observed during cycle 1.
The dose escalation process will be discontinued once the MTD is achieved.
Satraplatin in combo with vinorelbine
* Satraplatin (gelatin capsules) p.o. on days 1 to 5 (from 60 mg/m2 up to 80 mg/m2)
* Vinorelbine (soft capsules) p.o. on days 1, 8 and 15 (from 60 mg/m2 up to 80 mg/m2) The treatment is repeated every 4 weeks.
Interventions
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Satraplatin in combo with vinorelbine
* Satraplatin (gelatin capsules) p.o. on days 1 to 5 (from 60 mg/m2 up to 80 mg/m2)
* Vinorelbine (soft capsules) p.o. on days 1, 8 and 15 (from 60 mg/m2 up to 80 mg/m2) The treatment is repeated every 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histological/cytological diagnosis of solid tumors in which treatment with oral vinorelbine and oral platinum compounds(preferentially breast, NSCL, GU or GY tumors) is medically indicated
3. Progressive disease (also in terms of tumor markers only, like CA 125 for ovary and PSA for prostate). No measurable disease is necessary.
4. Age 18-75 years
5. Prior chemotherapy of ≤ 2 lines for advanced disease
6. ECOG Performance Status \< 2
7. Life expectancy of at least 3 months
8. The patient or his/her legal representative must be able to read, understand and provide written evidence of informed consent
9. Female patients must not be pregnant or lactating and must be willing to practice contraception. The effects of satraplatin on the developing human fetus are unknown. For this reason, women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation.
10. Male patients that are not surgically sterile must be practicing a medically acceptable contraceptive regimen while on study treatment
11. Adequate organ function as defined by the following:
* Serum creatinine \< 1.5 mg/dl (\< 132 umol/l)
* ANC \> 1500/microL
* Hb \> 10 g/dl
* Platelet \> 100,000/microL
* Total bilirubin \< ULN for the reference laboratory
* AST and ALT and alkaline phosphatase (AP) must be within the designated range allowing for eligibility.
Exclusion Criteria
2. Treatment with vinorelbine \< 6 months from time of enrolment
3. Known resistance to platinum chemotherapy containing regimens (resistance is defined as PD while on treatment or a progression free interval \< 6 months after completion of platinum therapy)
4. Known resistance to vinca alkaloids, treatment (including continuous infusion). Resistance is defined as PD while on treatment or a progression free interval \< 6 months after completion of therapy
5. Hypersensitivity or allergic reactions to platinum compounds or vinorelbine
6. Radiotherapy involving \> 30% of the active bone marrow
7. Radiotherapy \< 4 weeks prior to enrolment
8. Pre-existing peripheral neuropathy \> grade 1
9. Pre-existing CTCAE hearing loss or tinnitus ≥ grade 2
10. Metastatic brain or meningeal tumors unless the patient is \> 6 months from definitive therapy, had a negative imaging study within 4 weeks of study entry, is clinically stable with respect to the tumor at the time of study entry, and is not receiving steroid therapy or taper
11. Patients who have not recovered (\> grade 1) from the following toxicities of previous regimens before enrolment: fatigue, mucositis, nausea/vomiting, diarrhoea
12. Subject is currently enrolled in, or has not yet completed at least 30 days since ending other investigational device or drug trial(s) or is receiving other investigational agent(s)
13. Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, uncontrolled congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements
14. Pre-existing malabsorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption
15. History of human immunodeficiency (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
16. Concurrent use of medications that inhibit cytochrome P450 3A4
17. History of bone marrow or major organ transplant
18. Prior high dose treatment with PBSC support
18 Years
75 Years
ALL
No
Sponsors
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Agennix
INDUSTRY
Pierre Fabre Laboratories
INDUSTRY
Southern Europe New Drug Organization
OTHER
Responsible Party
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SENDO
Principal Investigators
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Cristiana Sessa, MD
Role: STUDY_CHAIR
Swiss Cancer Institute
Locations
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Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
Bellinzona, , Switzerland
Kantonspital Graubünden
Chur, , Switzerland
Countries
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References
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Gallerani E, Cathomas R, Sessa C, Digena T, Bartosek AA, Dal Zotto L, von Moos R. A phase I study of the oral platinum agent satraplatin in combination with oral vinorelbine in patients with advanced solid malignancies. Onkologie. 2013;36(1-2):40-5. doi: 10.1159/000346671. Epub 2013 Jan 28.
Other Identifiers
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2007DR2331
Identifier Type: OTHER
Identifier Source: secondary_id
SKSD00701
Identifier Type: -
Identifier Source: org_study_id