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Hormone-sensitive Metastatic Breast CancerPhase 2NCT01205685

Endocrine Therapy + OSI-906 With or Without Erlotinib for Hormone-Sensitive Metastatic Breast Cancer

A Phase 2 study testing OSI-906, Erlotinib and Letrozole in people with Hormone-sensitive Metastatic Breast Cancer, run by Vanderbilt-Ingram Cancer Center at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Erlotinib attacks a part of cancer cells that helps them live and grow. Studies done in human beings show that this drug can make a difference in the way anti-estrogens work in hormone-sensitive breast cancers. OSI-906 attacks a different part of the cancer cell that helps them live and grow. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
OSI-906, Erlotinib and Letrozole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
3 sitesUnited States
Study dates
May 2010to Jul 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must provide informed written consent.
  • Patients must be ≥18 years of age.
  • ECOG performance status 0-1.
  • Patients with clinical stage IV invasive mammary carcinoma, previously documented by histological analysis, which is ER-positive and/or PR-positive by immunohistochemistry (IHC), which had previous endocrine therapy in the metastatic setting or had metastatic recurrence within 6 months of adjuvant endocrine therapy. Patients may have either measurable or non-measurable disease, both are allowed.
  • Patients whose breast cancers are also HER2-overexpressed (IHC 3+ or FISHpositive) need to have had previous treatment exposure to trastuzumab (Herceptin®)
  • Life expectancy ≥ 6 months
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  • Patients must have adequate hematologic, hepatic, and renal function. All tests must be obtained less than 2 weeks from study entry. This includes:
  • ANC ≥1250/mm3
  • Platelet count ≥100,000/mm3
  • Creatinine ≤1.5X upper limits of normal
  • Bilirubin, SGOT, SGPT ≤ 1.5 X upper limits of normal if no liver metastasis present*
  • Bilirubin, SGOT, SGPT, alkaline phosphatase ≤ 3 X upper limits of normal if liver metastasis present* *for patients with Gilbert's syndrome, direct bilirubin will be measured instead of total bilirubin
  • Able to swallow and retain oral medication.
  • Pre-menopausal patients must have a negative pregnancy test prior to participating in the study. Women of childbearing age and their male counter parts should use a barrier method of contraception during and for 3 months following protocol therapy.
  • Post-menopausal female subjects should be defined prior to protocol enrollment by any of the following:
  • Subjects at least 55 years of age;
  • Subjects under 55 years of age and amenorrheic for at least 12 months or follicle-stimulating hormone (FSH) values ≥40 IU/L and estradiol levels
  • ≤20 IU/L;
  • Prior bilateral oophorectomy or prior radiation castration with amenorrhea for at least 6 months.
  • Patients may receive concurrent radiation therapy to painful bone metastases or areas of impending bone fracture as long as radiation therapy is initiated prior to study entry. Patients who have received prior radiotherapy must have recovered from any toxicity induced by this treatment (toxicity grade ≤ 1).
  • Patients must be disease-free of prior invasive cancers for > 5 years with the exception of basal or squamous cancer of the skin or cervical carcinoma in situ.
  • Subjects must complete all screening assessments as outlined in the protocol.
  • Patients must have available tissue (archived formalin-fixed paraffin embedded blocks (FFPB) or fresh frozen tissue from original diagnosis or metastatic setting)for correlative studies. Tissue needs to be sent to VUMC (see Appendix E) at the time of registration. Patients will not be able to start study drugs without tissue availability.

Who cannot join

  • Locally recurrent resectable breast cancer.
  • Pregnant or lactating women.
  • Patients must not have had > than 4 prior chemotherapy treatments in the metastatic setting. This restriction does not include endocrine therapies or single agent biologic therapies.
  • Use of CYP3A4 and CYP1A2 modifiers or drugs that prolong QTcF with high risk for Torsade de Pointes (see Appendix A)
  • Any kind of malabsorption syndrome significantly affecting gastrointestinal function.
  • History of other malignancy within 5 years prior to enrollment. Subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinomas are eligible.
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  • Patients with baseline QTcF> 450 msec
  • Patients with diabetes, glucose > 160 mg/dL or receiving ongoing antihyperglycemic therapies
  • Uncontrolled intercurrent illness including, but not limited to:
  • ongoing or active infection requiring parenteral antibiotics
  • impairment of lung function (COPD > grade 2, lung conditions requiring oxygen therapy)
  • symptomatic congestive heart failure (class III or IV of the New York Heart Association classification for heart disease)
  • unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months
  • uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg, found on two consecutive measurements separated by a 1-week period despite adequate medical support)
  • clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment [National Cancer Institute -Common Terminology Criteria for Adverse Events, Version 4.0, grade 3]
  • psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements including maintenance of a compliance/pill diary
  • Patients with symptomatic brain metastases (patients with a history of brain metastases must be clinically stable for more than 3 weeks from completion of radiation treatment and not taking steroids or therapeutic anticonvulsants that are CYP3A4 modifiers)
  • Patients with asymptomatic brain metastasis on prophylactic anticonvulsants that are CYP3A4 modifiers
  • Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, biologic therapy) other than the ones specified in the protocol. Patients must have discontinued the above cancer therapies for 1 week prior to the first dose of study medication, as well as recovered from toxicity (to ≤ than grade 1, except for alopecia, neuropathy, and ANC, which should be ≥ 1250/mm3) induced by previous treatments. Any other investigational drugs should be discontinued 2 weeks prior to the first dose of study medication.
  • Prior therapy with an IGF-1R inhibitor

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Vanderbilt-Ingram Oncology Cool Springs

    Franklin, Tennessee, 37067

  • Vanderbilt One Hundre Oaks

    Nashville, Tennessee, 37204

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: A Phase II Trial of Endocrine Therapy in Combination With OSI-906 (an IGF-1R Inhibitor) and Erlotinib (Tarceva®, an EGFR Inhibitor) in Patients With Hormone-sensitive Metastatic Breast Cancer

Erlotinib attacks a part of cancer cells that helps them live and grow. Studies done in human beings show that this drug can make a difference in the way anti-estrogens work in hormone-sensitive breast cancers. OSI-906 attacks a different part of the cancer cell that helps them live and grow. Studies done in the laboratory show that OSI-906 can make a difference in the way anti-estrogens work in hormone-sensitive breast cancers.

Read the detailed description

The safety run component of this trial is to determine the safety profile of the OSI-906, erlotinib and anti-endocrine treatment combination. The phase II component evaluates the antitumor activity of the combination OSI-906, erlotinib and endocrine therapy.

Being tested
OSI-906, Erlotinib, Letrozole, Goserelin

What participants receive

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

  • OSI-906Drug

    In a pill form by mouth, twice a day (12 hours apart)

    During the safety run portion of the study"

    • Dose level 2 = 150 mg twice a day
    • Dose level 1 = 100 mg twice a day
    • Dose level -1 = 100 mg twice a day
    • Dose level -2 = 100 mg twice a day

  • ErlotinibDrug

    During the safety run phase of the study:

    • Dose Level 2 = 100 mg/d
    • Dose Level 1 = 100 mg/d
    • Dose Level -1= 75 mg/d
    • Dose Level -2 = 50 mg/d

  • LetrozoleDrug

    In a pill form, by mouth, once per day at 2.5 mg/d.

  • GoserelinDrug

    For pre-menopausal patients only. Given as an injection once a month at 3.6 mg/month.

Study groups in NCT01205685
Study groupRoleWhat they receive
OSI-906 + Erlotinib + Letrozole + GoserelinExperimental* OSI-906 in a pill form, by mouth, twice a day (12 hours a part) * Erlotinib in a pill form, by mouth, once a day * Letrozole in a pill form, by mouth, once a day * Goserelin, by injection once per month for women who are pre-menopausal
Receives: Drug: OSI-906; Drug: Erlotinib; Drug: Letrozole; Drug: Goserelin

What is being measured

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

  1. Anti-tumor Activity of OSI-906

    Time to progression measured in months from study entry to date of disease progression

    Measured: From study entry to 6 months

Secondary outcomes (3)

  1. Safety Profile Based on Number of Patients With Each Worst-grade Toxicity

    According to National Cancer Institute Common Toxicity Criteria for Adverse Events with 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening/disabling, and 5 = death.

    Measured: Every 4 weeks up to 24 weeks

  2. Number of Participants With Tumor Response Per RECIST

    Per RECIST criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions

    Measured: Every 12 weeks to tumor progression

  3. Correlative Studies

    Biomarkers associated with response to OSI-906 + Erlotinib + Letrozole + Goserelin

    Measured: < or = to 2 weeks before initiation of Phase II study treatment period

Timeline

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

  1. First posted20 Sep 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionJul 2011
  4. Study completionJul 2011

Why it stopped: PI closed study early, all patients experienced severe toxicities and progressed

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01205685
Sponsor's protocol ID
VICC BRE 09112
Status last verified
Aug 2012
First submitted
17 Sep 2010
Last updated
11 Sep 2012
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OSI-906, Erlotinib and Letrozole in people with Hormone-sensitive Metastatic Breast Cancer, run by Vanderbilt-Ingram Cancer Center at 3 sites in United States.

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 23 inclusion and 20 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: stopped early, as of the sponsor's last update on 11 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 11 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Anti-tumor Activity of OSI-906 (time frame: From study entry to 6 months). 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 NCT01205685.

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 11 Sep 2012.

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