RAD001 in Combination With CP-751,871 in Patients Wtih Advanced Sarcomas and Other Malignant Neoplasms

NCT00927966 | Completed Phase 1 DMC

• 1 other identifier: 09-091
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine the safety of the combination of RAD001 and CP-751,871, as well as the highest dose of this combination that can be given to people safely. RAD001 is a newly discovered drug that may stop cancer cells from growing abnormally. This drug has been extensively studied in many cancers. In particular, it has shown to be effective in slowing down the growth of kidney cancer. CP-751,871 is another newly discovered drug that may stop tumor growth. It is currently being studied in a wide variety of cancers, and information from those other research studies suggests that these two drugs in combination may help to stop cancer growth.

Conditions

Sarcoma; Solid Tumor

Keywords

RAD001; CP-751,871; advanced sarcoma; advanced malignant solid tumor

Outcome Measures

Primary Outcomes (1)

• To assess the safety and tolerability of daily oral RAD001, administered in combination with CP-751,871 given as an intravenous infusion in patients with advanced sarcomas and other advanced solid tumors that are incurable with any current modality.

  3 years

Secondary Outcomes (2)

• To assess the pharmacokinetics of this combination regimen.

  3 years

• To allow a preliminary assessment of the anti-tumor effects of this novel drug combination.

  3 years

Study Arms (1)

RAD001 in combination with figitumumab

EXPERIMENTAL

Drug: RAD001; Drug: CP-751,871

Interventions

RAD001 DRUG

Taken orally once a day.

RAD001 in combination with figitumumab

CP-751,871 DRUG

Given intravenously on Day 1 of a 21-day cycle

RAD001 in combination with figitumumab

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed advanced sarcoma or other advanced malignant solid tumor for which no known curative therapy exists. Patients must have had prior progression on, intolerance or refused approved standard therapies proven to prolong life.
• Measurable disease per RECIST. A lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of the lesion prior to study enrollment
• years of age or older
• ECOG Performance Status 0-1
• Participants must have normal organ and marrow function as outlined in the protocol
• Fully recovered from the acute effects of prior cancer therapy before initiation of study drug
• Negative urine or serum pregnancy test within 7 days prior to initiation of study drug for women of child-bearing potential
• Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for up to 6 months after the last dose of study drug

You may not qualify if:

• Participants with gastrointestinal tumors (GIST) on approved tyrosine kinase inhibitors within 2 weeks prior to study entry
• All other participants who have had systemic anti-cancer therapy within 3 weeks (8 weeks for nitrosoureas or mitomycin C) prior to study entry
• Participants who have had radiotherapy and/or major surgery within 2 weeks prior to study entry
• Concurrent use of any other anti-cancer therapies, study agents, growth hormones, growth hormone inhibitors or aminoglycoside antibiotics
• Participants who have had chronic high dose immunosuppressive steroid therapy within 2 weeks prior to enrollment. Previous high dose steroid treatment \> 2 weeks prior to study entry, topical and inhaled corticosteroids are allowed
• Presence of symptomatic or uncontrolled brain or central nervous system metastases
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to RAD001 and/or CP-751,871
• Participants receiving any medications or substances that are inhibitors or inducers of CYP3A
• Uncontrolled diabetes
• Bleeding diathesis or requirement for therapeutic anticoagulation
• Uncontrolled intercurrent illness
• Pregnant or nursing women
• HIV positive individuals on combination anti-retroviral therapy

Sponsors & Collaborators

• Suzanne George, MD: lead
• Brigham and Women's Hospital: collaborator
• Novartis: collaborator
• Pfizer: collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Everolimus; figitumumab

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Suzanne George, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Director Center for Sarcoma and Bone Oncology

Study Record Dates

• First Submitted: June 24, 2009
• First Posted: June 25, 2009
• Study Start: July 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: November 14, 2013

Record last verified: 2013-11

Locations

US (1)