A Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery

Sarcoma Clinical Trial

Official title:

An Exploratory Biomarker Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143740
• Other study ID #: NP22890
• Secondary ID: 2009-015522-10
• Status: Completed
• Phase: Phase 1
• First received: June 11, 2010
• Last updated: November 1, 2016
• Start date: June 2010
• Est. completion date: March 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

This open-label study will evaluate efficacy, safety and tolerability of RO5045337 in patients with liposarcoma who are eligible for debulking surgery. Prior to surgery, patients will receive 2-3 cycles of RO5045337, orally for 10 days followed by 18 days of rest per cycle. Anticipated time on study treatment is 3 months. Patients with an incomplete resection may be treated for an additional 3 cycles with RO5045337.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >/=18 years of age

• well differentiated and/or dedifferentiated liposarcoma eligible for tumor debulking surgery

• willing to undergo tumor biopsies before, during and after treatment

• ECOG performance status 0-1

Exclusion Criteria:

• previous chemotherapy and/or radiation for liposarcoma; previous debulking surgery is acceptable

• patients receiving any other agent or therapy to treat their malignancy

• patients requiring anticoagulant therapy and/or anti-platelet therapy

• pre-existing gastrointestinal disorders which may interfere with absorption of drugs

• history of seizure disorders or unstable CNS metastases

• clinically significant cardiovascular disease

• history of long QT syndrome

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liposarcoma
• Sarcoma

Intervention

Drug:
• RO5045337
orally day 1-10 each 28-day cycle, 3 cycles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarker evidence of MDM2 and p53 pathway alterations (histologic, molecular and imaging analyses)		from baseline to week 12	No
Secondary	Safety and tolerability: Adverse events, laboratory parameters, ECG		up to approximately 4 months after study start	No
Secondary	Tumor response according to RECIST criteria assessed by CT or MRI		from baseline to week 7	No
Secondary	Correlation pharmacokinetics (AUC, Cmax, tmax, t1/2, CL/V, V/F) - pharmacodynamics/biomarkers		multiple sampling weeks 1 and 2	No