Satraplatin and Vinorelbine in Advanced Solid Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Southern Europe New Drug Organization.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Agennix
Pierre Fabre Laboratories
Information provided by:
Southern Europe New Drug Organization
ClinicalTrials.gov Identifier:
NCT01220284
First received: October 11, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Advanced Solid Tumors
Drug: Satraplatin in combo with vinorelbine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose-finding Study of Satraplatin in Combination With Oral Vinorelbine in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Southern Europe New Drug Organization:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) based upon study drug related dose limiting toxicities (DLTs) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    The Maximum Tolerated Dose (MTD) is defined as the dose at which 2 out of 3 to 6 patients experience a DLT.


Secondary Outcome Measures:
  • Safety [ Time Frame: whole study period ] [ Designated as safety issue: Yes ]
    Safety assessments include routine physical examinations and laboratory evaluations (blood cell counts, functional parameters and chemistry). Adverse events will be graded according to the NCI-CTCAE, Common Terminology Criteria for Adverse Events v.3.0.

  • Tumor response [ Time Frame: every 2 months ] [ Designated as safety issue: No ]
    Tumor response in target and non-target lesions will be assessed according to the RECIST criteria.


Enrollment: 27
Study Start Date: February 2008
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Drug: 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 Names:
  • - Satraplatin (codenamed JM216)
  • - Vinorelbine, Navelbine

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  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:

  1. Other chemotherapy treatment < 4 weeks prior to enrolment
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01220284

Locations
Switzerland
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
Bellinzona, Switzerland, 6500
Kantonspital Graubünden
Chur, Switzerland, 7000
Sponsors and Collaborators
Southern Europe New Drug Organization
Agennix
Pierre Fabre Laboratories
Investigators
Study Chair: Cristiana Sessa, MD Swiss Group for Clinical Cancer Research
  More Information

No publications provided by Southern Europe New Drug Organization

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: General Director, SENDO
ClinicalTrials.gov Identifier: NCT01220284     History of Changes
Other Study ID Numbers: SKSD00701, 2007DR2331
Study First Received: October 11, 2010
Last Updated: October 11, 2010
Health Authority: Switzerland: Swissmedic

Keywords provided by Southern Europe New Drug Organization:
solid tumors
oral treatment
platinum compound
vinca alkaloid
drug combination

Additional relevant MeSH terms:
Neoplasms
Vinorelbine
Vinblastine
Satraplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014