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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00811993
First received: December 18, 2008
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This study will evaluate the safety and tolerability of R1507 in combination wit h 12 distinct standard chemotherapy drug regimens and an additional R1507 monoth erapy 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 stu dy: untreated, treated and requiring further treatment, or treated and failed an d for whom adding R1507 represents a suitable treatment for their disease. All r egimens will first test doses of R1507 which are less than the maximally adminis tered dose, and if tolerated, the dose will be escalated in subsequent patients.

The anticipated time on study treatment is until disease progression, and the t arget sample size is 100-500 individuals.


Condition Intervention Phase
Neoplasms
Drug: RG1507
Drug: gemcitabine
Drug: erlotinib [Tarceva]
Drug: paclitaxel
Drug: bevacizumab [Avastin]
Drug: carboplatin
Drug: etoposide
Drug: mFOLFOX6
Drug: capecitabine [Xeloda]
Drug: trastuzumab [Herceptin]
Drug: sorafenib
Drug: irinotecan
Drug: cetuximab
Drug: temozolomide
Drug: docetaxel
Drug: pemetrexel
Drug: RO1507
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Adverse events, laboratory parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Trough levels of R1507 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: February 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Drug: gemcitabine
as prescribed
Drug: erlotinib [Tarceva]
as prescribed
Experimental: 2 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
Drug: paclitaxel
as prescribed
Drug: bevacizumab [Avastin]
as prescribed
Experimental: 3 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
Drug: carboplatin
as prescribed
Drug: etoposide
as prescribed
Experimental: 4 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
Drug: bevacizumab [Avastin]
as prescribed
Drug: mFOLFOX6
as prescribed
Experimental: 5 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
Drug: capecitabine [Xeloda]
as prescribed
Drug: trastuzumab [Herceptin]
as prescribed
Experimental: 6 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
Drug: sorafenib
as prescribed
Experimental: 7 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
Drug: erlotinib [Tarceva]
as prescribed
Drug: bevacizumab [Avastin]
as prescribed
Experimental: 8 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
Drug: irinotecan
as prescribed
Drug: cetuximab
as prescribed
Experimental: 9 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
Drug: paclitaxel
as prescribed
Drug: bevacizumab [Avastin]
as prescribed
Drug: carboplatin
as prescribed
Experimental: 10 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
Drug: temozolomide
as prescribed
Experimental: 11 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
Drug: bevacizumab [Avastin]
as prescribed
Drug: docetaxel
as prescribed
Experimental: 12 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
Drug: pemetrexel
as prescribed
Experimental: 13 Drug: RO1507
27mg/kg iv, monotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00811993

Locations
United States, Arizona
Tucson, Arizona, United States, 85724
United States, California
San Francisco, California, United States, 94115
Santa Monica, California, United States, 90025
United States, District of Columbia
Washington, District of Columbia, United States, 20007
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, North Carolina
Chapel Hill, North Carolina, United States, 27514
United States, Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00811993     History of Changes
Other Study ID Numbers: NO22068
Study First Received: December 18, 2008
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Etoposide
Paclitaxel
Irinotecan
Gemcitabine
Temozolomide
Docetaxel
Trastuzumab
Capecitabine
Bevacizumab
Cetuximab
Sorafenib
Carboplatin
Erlotinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on July 20, 2014