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

Primary Purpose

Sarcoma, Solid Tumor

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

RAD001

CP-751,871

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring RAD001, CP-751,871, advanced sarcoma, advanced malignant solid tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
18 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

Exclusion Criteria:

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

Sites / Locations

Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RAD001 in combination with figitumumab

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To assess the pharmacokinetics of this combination regimen.

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

Full Information

NCT ID

NCT00927966

First Posted

June 24, 2009

Last Updated

November 12, 2013

Sponsor

Suzanne George, MD

Collaborators

Brigham and Women's Hospital, Novartis, Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00927966

Brief Title

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

Official Title

Phase I Clinical Trial of RAD001 in Combination With CP-751,871 in Patients With Advanced Sarcomas and Other Malignant Neoplasms

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Suzanne George, MD

Collaborators

Brigham and Women's Hospital, Novartis, Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

In this research study, each "cycle" of study drug dosing lasts 21 days. In the first cycle, participants will come to the clinic on Days 1, 8, and 15. During cycles 2 through 4, participants will come to the clinic on Days 1 and 8. The rest of the clinic visits will occur on Day 1 of every cycle thereafter. During each cycle, participants will take RAD001 orally, once a day in the morning. In addition, participants will receive CP-751,871 intravenously once every cycle on the first day of each cycle. Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects, not everyone who participates in this research study will receive the same dose of the study drug. The dose will depend on the number of participants enrolled in the study and how well they tolerated their doses. Participants may remain on this research study as long as they do not have serious side effects or their diseae does not get worse.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcoma, Solid Tumor

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RAD001 in combination with figitumumab

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

RAD001

Intervention Description

Taken orally once a day.

Intervention Type

Drug

Intervention Name(s)

CP-751,871

Intervention Description

Given intravenously on Day 1 of a 21-day cycle

Primary Outcome Measure Information:

Title

Time Frame

3 years

Secondary Outcome Measure Information:

Title

To assess the pharmacokinetics of this combination regimen.

Time Frame

3 years

Title

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

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 18 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suzanne George, MD

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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