A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.

Neoplasms Clinical Trial

Official title:

A Dose-escalation Study of R1507 in Patients With Advanced Solid Tumors.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400361
• Other study ID #: BO19373
• Status: Completed
• Phase: Phase 1
• First received: November 15, 2006
• Last updated: November 1, 2016
• Start date: April 2006
• Est. completion date: April 2011

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 and pharmacokinetic profile of R1507 in patients with metastatic or locally advanced malignant solid tumors, non-Hodgkin's lymphoma or Hodgkin's lymphoma. Groups of patients will be sequentially enrolled to receive ascending doses of R1507 either weekly or three-weekly by intravenous infusion. The starting dose of 1mg/kg iv for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of safety, tolerability and pharmacokinetics 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 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• solid neoplasm, non-Hodgkin's lymphoma or Hodgkin's lymphoma;

• metastatic or locally advanced disease, not curable by any currently available treatment.

Exclusion Criteria:

• severe, uncontrolled systemic disease;

• patients who require treatment with glucocorticoids or immunosuppressive treatment within last 6 months;

• patients with diabetes mellitus.

Study Design

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• RG1507
Administered iv, either weekly or 3 weekly, at escalating doses (with a starting dose of 1mg/kg) (7 cohorts).

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, Cmax, Tmax, AUC, clearance, Vdss elimination half life		Throughout study	No
Secondary	Tumor response		Event driven	No