A Multiple Ascending Dose Study of R4733 in Patients With Advanced Solid Tumors.

Neoplasms Clinical Trial

Official title:

Multiple Ascending Dose (MAD) Study of R4733 Administered Orally in Patients With Refractory Metastatic or Locally Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00532090
• Other study ID #: NO21321
• Status: Completed
• Phase: Phase 1
• First received: September 18, 2007
• Last updated: November 1, 2016
• Start date: November 2007
• Est. completion date: August 2010

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will determine the maximum tolerated dose, safety and pharmacokinetic profile of R4733 (RO4929097), administered orally to patients with refractory metastatic or locally advanced solid tumors. The study will assess three different dosing schedules; in one schedule R4733 will be administered 3days on/ 4 days off, in another on days 1-7 of each 21 day cycle, and in a third schedule continuously daily. The starting dose for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of the safety and tolerability of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is 100-200 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• advanced and/or metastatic solid tumor malignancy;

• measurable or evaluable disease;

• ECOG performance status 0 or 1.

Exclusion Criteria:

• prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;

• prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drug. Dexamethasone may be allowed only as part of the supportive care measures;

• major surgery within 28 days of first receipt of study drug.

Study Design

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• RG4733
Administered orally daily at ascending doses to successive cohorts of patients
• RG4733
Administered orally at ascending doses to successive cohorts of patients, on a 3 days on/ 4 days off schedule
• RG4733
Administered orally at ascending doses to successive cohorts of patients, on days 1-7 of each 21 day cycle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AEs, laboratory parameters.		Throughout study	No
Secondary	Tumor assessments		day 15 cycle 1, at the end of cycle 2 and every 6 weeks thereafter	No
Secondary	Pharmacokinetic profile		After first dose and last dose (or day 15) of cycles 1 and 2	No