A Study of R1507 in Combination With Multiple Standard Chemotherapy Treatments in Patients With Advanced Solid Tumors

Neoplasms Clinical Trial

Official title:

Phase Ib Study To Evaluate The Safety Of Combining IGF-1R Antagonist R1507 With Multiple Standard Chemotherapy Drug Treatments In Patients With Advanced Malignancies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00811993
• Other study ID #: NO22068
• Status: Terminated
• Phase: Phase 1
• First received: December 18, 2008
• Last updated: November 1, 2016
• Start date: February 2009
• Est. completion date: December 2012

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 evaluate the safety and tolerability of R1507 in combination with 12 distinct standard chemotherapy drug regimens and an additional R1507 monotherapy arm in patients with advanced malignant neoplasms.The 12 regimens will be tested in parallel. There are 3 subsets of patients who are eligible for the study: untreated, treated and requiring further treatment, or treated and failed and for whom adding R1507 represents a suitable treatment for their disease. All regimens will first test doses of R1507 which are less than the maximally administered dose, and if tolerated, the dose will be escalated in subsequent patients. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 104
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• malignant neoplasms;

• failed prior standard curative therapy;

• ECOG performance Status of 0 or 1;

• adequate bone marrow, hepatic and renal function;

• life expectancy greater than 8 weeks.

Exclusion Criteria:

• chemotherapy within 2 weeks of start of therapy;

• prior irradiation within 4 weeks prior to start of therapy;

• prior treatment with agents targeting IGF-IR inhibition, or other investigational agents;

• major surgery or significant traumatic injury within 2 weeks prior to study start;

• patients receiving concurrent antibody or immunotherapy;

• other exclusion criteria are related to specific treatment regimens.

Study Design

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• RG1507
Starting dose of >=3mg/kg iv escalating to a maximum dose of <=16mg/kg iv, depending on dosing schedule in each combination treatment arm
• RO1507
27mg/kg iv, monotherapy
• bevacizumab [Avastin]
as prescribed
• capecitabine [Xeloda]
as prescribed
• carboplatin
as prescribed
• cetuximab
as prescribed
• docetaxel
as prescribed
• erlotinib [Tarceva]
as prescribed
• etoposide
as prescribed
• gemcitabine
as prescribed
• irinotecan
as prescribed
• mFOLFOX6
as prescribed
• paclitaxel
as prescribed
• pemetrexel
as prescribed
• sorafenib
as prescribed
• temozolomide
as prescribed
• trastuzumab [Herceptin]
as prescribed

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	Adverse events, laboratory parameters, vital signs		Throughout study	No
Secondary	Trough levels of R1507		Throughout study	No