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Breast CancerPhase 2NCT00736970

Oral Deforolimus With Trastuzumab for Patients With HER2-positive Trastuzumab-Refractory Metastatic Breast Cancer (8669-009)

A Phase 2 study testing ridaforolimus and trastuzumab in people with Breast Cancer and Breast Neoplasms, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical trial will study the use of ridaforolimus in metastatic breast cancer subjects whose tumors have shown a resistance to trastuzumab (herceptin). The goal of this study is to find out if subjects treated with ridaforolimus in combination with trastuzumab have a positive response to the treatment, and if… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer, Breast Neoplasms
What is being tested?
ridaforolimus and trastuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
No sites listed yet
Study dates
Jul 2008to May 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female, 18 years of age or older
  • Histologically confirmed HER2-positive metastatic breast cancer
  • Trastuzumab-resistance
  • Measurable disease, according to RECIST guidelines
  • ECOG performance status less than or equal to 1
  • Life expectancy greater than 3 months
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  • No prior treatment with temsirolimus, everolimus, rapamycin, or any other mTOR inhibitor
  • At least 4 weeks must have lapsed between prior investigational therapy, chemotherapy or radiotherapy, and the first dose of ridaforolimus
  • Left ventricular ejection greater than or equal to 50%
  • Adequate cardiovascular function
  • Adequate hematological, hepatic, and renal function
  • Serum cholesterol less than or equal to 350 mg/dL and triglycerides less than or equal to 400 mg/dL
  • Negative pregnancy test within 7 days prior to first dose of study drug and must use an approved contraceptive method from screening to 30 days after the last dose of study drug
  • Availability and patient consent to obtain archival tissue samples
  • Signed informed consent

Who cannot join

  • Inadequate recovery from any prior surgical procedure or having undergone any major surgery within 2 weeks before trial entry
  • Grade 1 or Grade 2 hypersensitivity reactions to prior trastuzumab therapy if these reactions prevented further trastuzumab administration
  • Grade 3 or Grade 4 hypersensitivity reaction to prior trastuzumab
  • Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest
  • Known allergy to macrolide antibiotics
  • Pregnant or breast-feeding
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  • Know history of HIV
  • Diagnosis of brain metastasis or leptomeningeal carcinomatosis within 3 months
  • Other malignancies within the past 3 years, except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin
  • Active infection requiring prescription intervention
  • Newly diagnosed or poorly controlled Type 1 or 2 diabetes
  • Other concurrent illness which, in the Investigator's judgment, would either compromise the patient's safety or interfere with the evaluation of the safety of the study drug
  • Concurrent treatment with medications that strongly induce or inhibit cytochrome P450.
  • Any condition that renders patient unable to fully understand and provide informed consent and/or comply with the protocol

About this study

Official title: A Phase II Trial of Oral Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, in Combination With Trastuzumab for Patients With HER2-positive Trastuzumab-Refractory Metastatic Breast Cancer

This clinical trial will study the use of ridaforolimus in metastatic breast cancer subjects whose tumors have shown a resistance to trastuzumab (herceptin). The goal of this study is to find out if subjects treated with ridaforolimus in combination with trastuzumab have a positive response to the treatment, and if treatment with ridaforolimus in combination with trastuzumab prolongs survival.

Being tested
ridaforolimus, trastuzumab
Keywords
ridaforolimus, deforolimus, AP23573, breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ridaforolimusDrug

    Also called deforolimus, AP23573, MK-8669, ridaforolimus was also known as deforolimus until May 2009

    10 mg oral tablets administered at 40 mg once daily for 5 consecutive days each week, followed by 2 days without ridaforolimus.

  • trastuzumabDrug

    Also called Herceptin

    single intravenous infusion every week; initial dose of 4 mg/kg over 90 minutes, then 2 mg/kg over 30 minutes

Study groups in NCT00736970
Study groupRoleWhat they receive
1Experimental10 mg oral tablets administered at 40 mg once daily for 5 consecutive days each week, followed by 2 days without ridaforolimus
Receives: Drug: ridaforolimus; Drug: trastuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) measured by modified RECIST guidelines

    Measured: Duration of the study

Secondary outcomes (4)

  1. Characterize the overall safety and tolerability of oral deforolimus administered in combination with standard dose trastuzumab

    Measured: Duration of the study

  2. Evaluate the clinical-benefit response rate (CR or PR, or SD ≥ six 4-week cycles)

    Measured: Throughout the trial

  3. Evaluate additional efficacy endpoints, such as duration of response, time to tumor progression, progression-free survival, progression free survival rate, and overall survival

    Measured: Duration of the trial

  4. Perform exploratory molecular analyses

    Measured: Duration of the trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionJan 2011
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00736970
Sponsor's protocol ID
8669-009
Other IDs
AP23573-08-207
Status last verified
Aug 2015
First submitted
14 Aug 2008
Last updated
27 Aug 2015
Results posted
No
Data monitoring committee
No

Publications

  • Seiler M, Ray-Coquard I, Melichar B, Yardley DA, Wang RX, Dodion PF, Lee MA. Oral ridaforolimus plus trastuzumab for patients with HER2+ trastuzumab-refractory metastatic breast cancer. Clin Breast Cancer. 2015 Feb;15(1):60-5. doi: 10.1016/j.clbc.2014.07.008. Epub 2014 Aug 17.

    PubMed 25239224

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ridaforolimus and trastuzumab in people with Breast Cancer and Breast Neoplasms, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) measured by modified RECIST guidelines (time frame: Duration of the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00736970, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2015.

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