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

NCT00811993 | Terminated Phase 1

• 1 other identifier: NO22068
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

• Adverse events, laboratory parameters, vital signs

  Throughout study

Secondary Outcomes (1)

• Trough levels of R1507

  Throughout study

Study Arms (13)

1

EXPERIMENTAL

Drug: RG1507; Drug: erlotinib [Tarceva]; Drug: gemcitabine

10

EXPERIMENTAL

Drug: RG1507; Drug: temozolomide

11

EXPERIMENTAL

Drug: RG1507; Drug: bevacizumab [Avastin]; Drug: docetaxel

12

EXPERIMENTAL

Drug: RG1507; Drug: pemetrexel

13

EXPERIMENTAL

Drug: RO1507

2

EXPERIMENTAL

Drug: RG1507; Drug: bevacizumab [Avastin]; Drug: paclitaxel

3

EXPERIMENTAL

Drug: RG1507; Drug: carboplatin; Drug: etoposide

4

EXPERIMENTAL

Drug: RG1507; Drug: bevacizumab [Avastin]; Drug: mFOLFOX6

5

EXPERIMENTAL

Drug: RG1507; Drug: capecitabine [Xeloda]; Drug: trastuzumab [Herceptin]

6

EXPERIMENTAL

Drug: RG1507; Drug: sorafenib

7

EXPERIMENTAL

Drug: RG1507; Drug: bevacizumab [Avastin]; Drug: erlotinib [Tarceva]

8

EXPERIMENTAL

Drug: RG1507; Drug: cetuximab; Drug: irinotecan

9

EXPERIMENTAL

Drug: RG1507; Drug: bevacizumab [Avastin]; Drug: carboplatin; Drug: paclitaxel

Interventions

RG1507 DRUG

Starting dose of \>=3mg/kg iv escalating to a maximum dose of \<=16mg/kg iv, depending on dosing schedule in each combination treatment arm

1; 10; 11; 12; 2; 3; 4; 5; 6; 7; 8; 9

RO1507 DRUG

27mg/kg iv, monotherapy

13

bevacizumab [Avastin] DRUG

as prescribed

11; 2; 4; 7; 9

capecitabine [Xeloda] DRUG

as prescribed

5

carboplatin DRUG

as prescribed

3; 9

cetuximab DRUG

as prescribed

8

docetaxel DRUG

as prescribed

11

erlotinib [Tarceva] DRUG

as prescribed

1; 7

etoposide DRUG

as prescribed

3

gemcitabine DRUG

as prescribed

1

irinotecan DRUG

as prescribed

8

mFOLFOX6 DRUG

as prescribed

4

paclitaxel DRUG

as prescribed

2; 9

pemetrexel DRUG

as prescribed

12

sorafenib DRUG

as prescribed

6

temozolomide DRUG

as prescribed

10

trastuzumab [Herceptin] DRUG

as prescribed

5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (8)

Unknown Facility

Tucson, Arizona, 85724, United States

Location

Unknown Facility

San Francisco, California, 94115, United States

Location

Unknown Facility

Santa Monica, California, 90025, United States

Location

Unknown Facility

Washington D.C., District of Columbia, 20007, United States

Location

Unknown Facility

Chicago, Illinois, 60637, United States

Location

Unknown Facility

Rochester, Minnesota, 55905, United States

Location

Unknown Facility

Chapel Hill, North Carolina, 27514, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

RG-1507 monoclonal antibody; Bevacizumab; Capecitabine; Carboplatin; Cetuximab; Docetaxel; Erlotinib Hydrochloride; Etoposide; Gemcitabine; Irinotecan; Paclitaxel; Sorafenib; Temozolomide; Trastuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Camptothecin; Alkaloids; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines; Dacarbazine; Triazenes; Imidazoles; Azoles

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 19, 2008
• Study Start: February 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (8)