AUY922 With Lapatinib and Letrozole for ER+ HER2+ Advanced Breast Cancer

NCT01361945 | Withdrawn Phase 1

• 1 other identifier: CAUY922ZN11
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to find out what effects, administering infusions of AUY922 with hormonal therapy (letrozole) and oral targeted drug (lapatinib) will have on the patients with advanced breast cancer known as ER+ HER2 +.

Conditions

Breast Cancer; Metastatic Breast Cancer; HER-2 Positive Breast Cancer; ER Positive Breast Cancer

Keywords

ER+; HER2+; Breast

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  noted by tumor response using RECIST criteria

  2 years

Study Arms (1)

AUY922

EXPERIMENTAL

Single Arm

Drug: AUY922

Interventions

AUY922 DRUG

AUY 922 is given intravenously weekly; letrozole and lapatinib are given orally

Also known as: Intravenous drug

AUY922

Eligibility Criteria

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

You may qualify if:

• Age 18 years
• Able to sign Informed Consent
• Patients must have the following laboratory values:
• Absolute Neutrophil Count (ANC) 1.5x109/L Hemoglobin (Hgb) 9 g/dl Platelets (plt) 100x109/L
• Potassium within normal limits
• Total calcium (corrected for serum albumin) and Phosphorus within normal limits
• Magnesium above LLN or correctable with supplements
• AST/SGOT and ALT/SGPT ≤ 1.5 x Upper Limit of Normal (ULN) if AP \> 2.5 ULN
• AST/SGOT and ALT/SGPT ≤ 2.5 x Upper Limit of Normal (ULN) if AP ≤ 5.0 x ULN if
• Serum bilirubin 1.5 x ULN
• Serum creatinin 1.5 x ULN or 24-hour clearance 50 ml/min
• Negative serum pregnancy test. The serum pregnancy test must be obtained prior to the first administration of AUY922 (≤ 72 hours prior to dosing) in all pre-menopausal women and women \<2 years after the onset of menopause
• Histologically confirmed HER2 + and ER+ or PR + (i.e., HR+) Postmenopausal women with Metastatic breast cancer or resistant locally advanced breast cancer.
• Stage of disease (stage IIIb/c not responding or progressing to standard therapy with trastuzumab) or stage IV receiving first line treatment in the metastatic setting . All patients should have documented clinical progression prior to entering study
• Prior chemotherapy for metastatic stage IV disease is prohibited for patients enrolled in phase II, but allowed up to 3 lines for patients enrolled in Phase I. Prior neoadjuvant/adjuvant chemotherapy, antiestrogens, and radiotherapy are allowed. Adjuvant hormonal therapy including aromatase inhibitors are permitted in the adjuvant, neoadjuvant or metastatic setting if discontinued at least two weeks prior to starting study treatment. Trastuzumab is permitted in the adjuvant, neoadjuvant or metastatic setting if discontinued at least 4 weeks prior to study treatment

You may not qualify if:

• Unresolved diarrhea ≥ CTCAE (v4.02) grade 1
• Pregnant or lactating women
• Impaired cardiac function, including any one of the following:
• History (or family history) of long QT syndrome
• Mean QTc ≥ 450 msec on baseline ECG
• History of clinically manifested ischemic heart disease ≤ 6 months prior to study start or History of heart failure or left ventricular (LV) dysfunction (LVEF ≤ 45%) by MUGA or ECHO or arrythmia
• Patients known to be HIV positive. Testing is not required in the absence of clinical signs and symptoms suggesting HIV infection.
• Known hypersensitivity to any of the study drugs or their excipients
• Participation in another clinical study within 30 days before first study treatment

Sponsors & Collaborators

• Texas Tech University Health Sciences Center, El Paso: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

5-(2,4-dihydroxy-5-isopropylphenyl)-4-(4-morpholin-4-ylmethylphenyl)isoxazole-3-carboxylic acid ethylamide; Infusion Pumps

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Artificial Organs; Surgical Equipment

Study Officials

• Zeina Nahleh, M.D.

  Texas Tech University Health Sciences Center, El Paso

  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: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: May 27, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 9, 2017

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share