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

Roche

Status and phase: Terminated; Phase 1

Conditions: Neoplasms

Treatments: Drug: docetaxel; Drug: carboplatin; Drug: paclitaxel; Drug: mFOLFOX6; Drug: etoposide; Drug: RG1507; Drug: sorafenib; Drug: trastuzumab [Herceptin]; Drug: cetuximab; Drug: erlotinib [Tarceva]; Drug: pemetrexel; Drug: gemcitabine; Drug: irinotecan; Drug: bevacizumab [Avastin]; Drug: capecitabine [Xeloda]; Drug: temozolomide; Drug: RO1507

Study type: Interventional

Funder types: Industry

Identifiers

NCT00811993

NO22068

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 13 patient groups

1

Experimental group

Treatment:

Drug: erlotinib [Tarceva]

Drug: gemcitabine

Drug: RG1507

10

Experimental group

Treatment:

Drug: temozolomide

Drug: RG1507

11

Experimental group

Treatment:

Drug: bevacizumab [Avastin]

Drug: docetaxel

Drug: RG1507

12

Experimental group

Treatment:

Drug: pemetrexel

Drug: RG1507

13

Experimental group

Treatment:

Drug: RO1507

2

Experimental group

Treatment:

Drug: paclitaxel

Drug: bevacizumab [Avastin]

Drug: RG1507

3

Experimental group

Treatment:

Drug: carboplatin

Drug: etoposide

Drug: RG1507

4

Experimental group

Treatment:

Drug: mFOLFOX6

Drug: bevacizumab [Avastin]

Drug: RG1507

5

Experimental group

Treatment:

Drug: capecitabine [Xeloda]

Drug: trastuzumab [Herceptin]

Drug: RG1507

6

Experimental group

Treatment:

Drug: sorafenib

Drug: RG1507

7

Experimental group

Treatment:

Drug: bevacizumab [Avastin]

Drug: erlotinib [Tarceva]

Drug: RG1507

8

Experimental group

Treatment:

Drug: irinotecan

Drug: cetuximab

Drug: RG1507

9

Experimental group

Treatment:

Drug: carboplatin

Drug: paclitaxel

Drug: bevacizumab [Avastin]

Drug: RG1507