A Phase 2 Study of Amrubicin in Relapsed or Refractory Thymic Malignancies

NCT01364727 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB-20444SU-01142011-7369THOR0003
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief Summary

A research study of the drug amrubicin in patients with cancer of the thymus (thymoma or thymic carcinoma). We hope to learn whether this drug is an effective and safe treatment for thymic cancers.

Conditions

Thymoma; Thymus Cancer; Thymic Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  Participants received amrubicin 35 mg/m2 IV days 1 to 3, every 3 weeks, until progression or toxicity. Tumor response rate was assessed radiographically by the Response Evaluation Criteria In Solid Tumors (RECIST), and the overall response rate (ORR) was expressed as the sum of the Complete Response (CR) rate and the Partial Response (PR) rate. RECIST criteria define when cancer patients improve ("respond"); stay the same ("stable"); or worsen ("progression") during treatments. The criteria presume that linear measures are an adequate substitute for 2-dimensional (2D) methods and includes 4 response categories: * CR = Disappearance of all target lesions * PR = 30% decrease in the sum of the longest diameter of target lesions * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions * Stable disease (SD) = Small changes that do not meet above criteria

  2 years

Secondary Outcomes (2)

• Median Progression-free Survival (PFS)

  2 years

• Disease Control Rate (DCR)

  2 years

Study Arms (1)

Amrubicin

EXPERIMENTAL

Amrubicin 35mg/m2 IV days 1-3 every 3 weeks

Drug: Amrubicin

Interventions

Amrubicin DRUG

35 mg/m2; IV on days 1-3 each 3 week cycle

Also known as: Calsed

Amrubicin

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed invasive or metastatic thymoma or thymic carcinoma. Locally invasive disease is acceptable, provided it is not resectable.
• Previous treatment with at least one prior chemotherapy regimen.
• Documented progressive disease after the most recent chemotherapy regimen.
• Presence of measurable disease on imaging within 4 weeks prior to first dose
• Completion of prior systemic therapy at least 4 weeks prior to first dose.
• Any prior immunotherapy therapy completed at least 8 weeks prior to first dose.
• Any prior surgery completed at least 4 weeks prior to first dose, with adequate recovered from surgery.
• Any prior radiation therapy must have no residual toxic effects of therapy. Chest radiotherapy with curative intent to the primary disease complex must have been completed ≥ 28 days prior to first dose. Cranial radiation must have been completed ≥ 21 days prior to first dose. Radiotherapy to all other areas must have been completed ≥ 7 days prior to first dose.
• Age ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Leukocytes ≥ 3000/mm³
• Absolute neutrophil count ≥ 1500/mm³
• Platelets ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/d
• Serum bilirubin \< 1.5 x institutional upper limit of normal (ULN)

You may not qualify if:

• Current use, or use within 4 weeks prior to first dose, of any other investigational agents.
• Known history of allergic reactions attributed to compounds of similar chemical or biologic composition to amrubicin.
• Active malignancy requiring treatment other than thymic malignancy.
• Pregnant or nursing females due to unknown toxic effects of amrubicin on the developing fetus or in breast milk. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Symptomatic central nervous system metastatic disease. Patients with asymptomatic brain metastases allowed. If treated with surgical resection or radiation therapy, the patient must be stable for \>= 2 weeks after completion of therapy. If the patient is on corticosteroids, the dose of corticosteroids, the dose of corticosteroids must have been stable for \>= 2 weeks prior to first dose of study treatment, or be in the process of being tapered.
• Concurrent severe or uncontrolled medical disease (including but not limited to active systemic infection, diabetes, hypertension, coronary artery disease, congestive hear failure and mental illness) that in the opinion of the investigator would compromise the safety of the patient or compromise the ability of the patient to complete the study.
• Known history of seropositive human immunodeficiency virus (HIV) or use of immunosuppressive medications for other conditions that would, in the opinion of the investigator, increase the risk of serious neutropenic complications.

Sponsors & Collaborators

• Heather Wakelee: lead
• Celgene: collaborator

Study Sites (2)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Thymoma; Thymus Neoplasms

Interventions

amrubicin

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Heather A Wakelee, MD
• Organization: Stanford University Medical Center

hwakelee@stanford.edu

650-736-7221

Study Officials

• Heather A. Wakelee

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor-Med

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 2, 2011
• Study Start: June 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: December 31, 2018
• Last Updated: April 16, 2019
• Results First Posted: March 14, 2017

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)