Satraplatin and Vinorelbine in Advanced Solid Tumors

NCT01220284 | Unknown Phase 1

• 2 other identifiers: SKSD007012007DR2331
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

Vinorelbine (NVB) and platinum compounds are anticancer agents with broad spectrum of efficacy, clinically and preclinically proven synergism and only partially overlapping toxicities. Combinations with vinorelbine and platinum compounds with limited neurotoxicity are among the most used palliative regimens in a variety of solid tumors, including NSCLC, breast and cervical cancer. The oral platinum analogue satraplatin (SATRA) has been brought into clinical development because of the antitumor activity and toxicity comparable to those of carboplatin, together with a good acceptability of the oral administration.The recent availability of oral formulation of anticancer agents of proven efficacy in some indications is likely to become a valid option which could affect clinical daily management. The oral administration of vinorelbine and satraplatin might represent a reasonable option of palliative treatment in patients with advanced breast cancer, NSCL, GU or GY tumors for which a curative treatment can not be provided.

Conditions

Advanced Solid Tumors

Keywords

solid tumors; oral treatment; platinum compound; vinca alkaloid; drug combination

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) based upon study drug related dose limiting toxicities (DLTs)

  The Maximum Tolerated Dose (MTD) is defined as the dose at which 2 out of 3 to 6 patients experience a DLT.

  28 days

Secondary Outcomes (2)

• Safety

  whole study period

• Tumor response

  every 2 months

Study Arms (1)

Satraplatin in combo with vinorelbine

EXPERIMENTAL

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.

Drug: Satraplatin in combo with vinorelbine

Interventions

Satraplatin in combo with vinorelbine DRUG

* 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.

Also known as: - Satraplatin (codenamed JM216), - Vinorelbine, Navelbine

Satraplatin in combo with vinorelbine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically/ cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative chemotherapy measures do not exist or are no longer effective.
• 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
• Progressive disease (also in terms of tumor markers only, like CA 125 for ovary and PSA for prostate). No measurable disease is necessary.
• Age 18-75 years
• Prior chemotherapy of ≤ 2 lines for advanced disease
• ECOG Performance Status \< 2
• Life expectancy of at least 3 months
• The patient or his/her legal representative must be able to read, understand and provide written evidence of informed consent
• 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.
• Male patients that are not surgically sterile must be practicing a medically acceptable contraceptive regimen while on study treatment
• 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

You may not qualify if:

• Other chemotherapy treatment \< 4 weeks prior to enrolment
• Treatment with vinorelbine \< 6 months from time of enrolment
• 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)
• 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
• Hypersensitivity or allergic reactions to platinum compounds or vinorelbine
• Radiotherapy involving \> 30% of the active bone marrow
• Radiotherapy \< 4 weeks prior to enrolment
• Pre-existing peripheral neuropathy \> grade 1
• Pre-existing CTCAE hearing loss or tinnitus ≥ grade 2
• 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
• Patients who have not recovered (\> grade 1) from the following toxicities of previous regimens before enrolment: fatigue, mucositis, nausea/vomiting, diarrhoea
• 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)
• 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
• Pre-existing malabsorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption
• History of human immunodeficiency (HIV) or acquired immunodeficiency syndrome (AIDS) related illness

Sponsors & Collaborators

• Southern Europe New Drug Organization: lead
• Agennix: collaborator
• Pierre Fabre Laboratories: collaborator

Study Sites (2)

Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

Bellinzona, 6500, Switzerland

Location

Kantonspital Graubünden

Chur, 7000, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 23429330 DERIVED

MeSH Terms

Interventions

satraplatin; Vinorelbine

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Cristiana Sessa, MD

  Swiss Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 11, 2010
• First Posted: October 13, 2010
• Study Start: February 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: February 1, 2011
• Last Updated: October 13, 2010

Record last verified: 2010-09

Locations

CH (2)