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

Conditions

• Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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
• RO1507 — DRUG
  27mg/kg iv, monotherapy
• bevacizumab [Avastin] — DRUG
  as prescribed
• capecitabine [Xeloda] — DRUG
  as prescribed
• carboplatin — DRUG
  as prescribed
• cetuximab — DRUG
  as prescribed
• docetaxel — DRUG
  as prescribed
• erlotinib [Tarceva] — DRUG
  as prescribed
• etoposide — DRUG
  as prescribed
• gemcitabine — DRUG
  as prescribed
• irinotecan — DRUG
  as prescribed
• mFOLFOX6 — DRUG
  as prescribed
• paclitaxel — DRUG
  as prescribed
• pemetrexel — DRUG
  as prescribed
• sorafenib — DRUG
  as prescribed
• temozolomide — DRUG
  as prescribed
• trastuzumab [Herceptin] — DRUG
  as prescribed

Study Details

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.

Key Dates

Start date

Feb 28, 2009

Status verified

Nov 2016

Primary completion

Dec 31, 2012

Completion

Dec 31, 2012

Study Design

Enrollment

104 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 1
• Experimental: 10
• Experimental: 11
• Experimental: 12
• Experimental: 13
• Experimental: 2
• Experimental: 3
• Experimental: 4
• Experimental: 5
• Experimental: 6
• Experimental: 7
• Experimental: 8
• Experimental: 9

Primary Outcome Measure

Adverse events, laboratory parameters, vital signs [ Time Frame: Throughout study ]

Locations (8)

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