Roche trials database

Trial information

A Multiple Ascending Dose Study of the mTOR Inhibitor (RAD001) in Combination With R1507 in Patients With Advanced Solid Tumors

Status:

Active, not recruiting

Protocol number:

NO21884

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific Title:

Multiple Ascending Dose (MAD) Phase Ib/II study of the mTOR inhibitor (RAD001) in combination with the IGF-1R Antagonist (R1507) for the treatment of patients with advanced solid tumors

Brief summary:

This 2 part study will assess the safety, tolerability and efficacy of a combination of oral daily RAD001 and intravenous 3-weekly R1507 in patients with advanced solid tumors. In Part 1 of the study, patients will be enrolled sequentially to receive 5mg by mouth (po) RAD001 daily + 16mg/kg intravenous (iv) R1507 every 3 weeks (level 1) and if tolerated, 10mg po RAD001 daily + 16mg/kg iv R1507 every 3 weeks (level 2).In Part 2 of the study, patients with 1) advanced renal cell cancer and 2) advanced pancreatic neuroendocrine tumors will receive the maximum tolerated dose regimen from Part 1 (5mg or 10mg po RAD001 + 16mg/kg iv R1507). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is 11.

Study phase:

I

Study type:

Interventional; Treatment; Non-randomized; Open label; Uncontrolled; Single group; Safety/efficacy study

Conditions:

• Neoplasms

Primary outcome:

1. Maximum tolerated dose of RAD001, in combination with R1507 (Part 1 Time frame: First 3 week cycle of treatment
2. Progression-free survival (Part 2) Time frame: 24 weeks

Key secondary outcomes:

1. Overall objective response rate; duration of response; overall survival Time frame: Event driven; monitored throughout study

Inclusion criteria:

• adult patients, >=18 years of age;
• histologically confirmed recurrent or refractory advanced solid tumor (Part 1);
• advanced metastatic renal cell cancer OR advanced metastatic pancreatic neuroendocrine tumors, with evidence of progressive disease (Part 2);
• measurable disease (Part 2);
• ECOG performance status 0-2.

Exclusion criteria:

• prior treatment with agents acting via inhibition of IGF-IR pathway;
• prior treatment with agents acting via inhibition of mTOR (Part 2);
• untreated CNS metastases;
• current anti-cancer therapy, or radiotherapy or chemotherapy <=4 weeks prior to enrollment;
• other known malignancy requiring treatment.

Gender:

Males or Females

Age limits:

Min: 18 years Max: N/A (No limit)

Accepts healthy volunteers:

No

Anticipated start date:

November, 2009

Trial registration date:

16.04.2009

Date last updated:

04.06.2013

This trial was conducted at the following locations:

Italy

• MILANO

UNITED STATES

• New York, NY
• San Antonio, TX

Link to trial result