NCT01525589

Brief Summary

A Clinical Trial of PM01183 in Metastatic Breast Cancer to assess the antitumor activity of PM01183 ,to evaluate whether the presence of a known germline mutation in BRCA 1/2 predicts response to PM01183 in Metastatic Breast Cancer (MBC) patients, to evaluate the safety profile of this PM01183 to analyze the pharmacokinetics (PK) and PK/PD (pharmacokinetic/pharmacodynamic) correlations and to evaluate the pharmacogenomic (PGx) expression profile in tumor samples.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Jun 2012

Typical duration for phase_2 breast-cancer

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 3, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

June 13, 2012

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
2 years until next milestone

Results Posted

Study results publicly available

September 25, 2020

Completed
Last Updated

September 25, 2020

Status Verified

November 1, 2018

Enrollment Period

6.3 years

First QC Date

January 30, 2012

Results QC Date

July 20, 2020

Last Update Submit

September 4, 2020

Conditions

Breast Cancer

Keywords

Breast cancerPM01183lurbinectedinPharma Mar

Outcome Measures

Primary Outcomes (2)

  • Overall Response Rate (ORR)

    The overall response rate is defined as the percentage of patients with a confirmed response, either complete response (CR) or partial response (PR), according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1. Per RECIST v1.1 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; PR \>=30% decrease in the sum of the longest diameter of target lesions.

    Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment

  • Overall Response

    Overall Response Rate (ORR) in the population evaluable for efficacy according to RECIST v.1.1. ORR was defined as the percentage of patients with a confirmed response, either CR or PR, according to the RECIST v.1.1 for target lesions and assessed by MRI: CR, complete response: Disappearance of all target lesions; PD, progressive disease: 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; PR, partial response: \>=30% decrease in the sum of the longest diameter of target lesions; SD, stable disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; TF, treatment failure.

    Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment

Secondary Outcomes (11)

  • Duration of Response

    Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment

  • Duration of Response Rate at 6 Months

    Time between the response criteria date and the date when disease progression, recurrence or death was documented, up to 6 months

  • Duration of Response Rate at 12 Months

    Time between the response criteria date and the date when disease progression, recurrence or death was documented, up to 12 months

  • Clinical Benefit Rate

    Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment

  • Progression-free Survival (PFS)

    36 months

  • +6 more secondary outcomes

Study Arms (1)

PM01183

EXPERIMENTAL
Drug: PM01183

Interventions

PM01183DRUG

PM01183 drug product (DP) is presented as a lyophilized powder for concentrate for solution for infusion with two strengths: 1 mg/vial and 4 mg/vial

PM01183

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women ≥ 18 and ≤ 75 years of age.
  • Voluntary signed informed consent form (ICF).
  • Proven diagnosis of metastatic breast cancer (MBC).
  • At least one, but no more than three, prior chemotherapy regimens for MBC.
  • Patients with known HER-2 overexpressing MBC must have failed at least one prior trastuzumab-containing regimen for metastatic disease.
  • Disease evaluable for response by specific appropriate criteria.
  • No or minimal disease-related symptoms not affecting patient daily activities.
  • Adequate major organ function (normal or minimal alteration in liver, kidney, hematological, metabolic and cardiac function)
  • Wash out periods prior to Day 1 of Cycle 1:
  • At least three weeks since the last chemotherapy (six weeks in some particular cases) and At least four weeks since the last radiotherapy (RT) \> 30 Gy) and At least one week since the last hormonal therapy and At least two weeks since the last biological/investigational therapy
  • Minimal or no ongoing toxicity from immediately prior therapy according to specific appropriate criteria. Mild ongoing toxicity is allowed in case of alopecia, skin toxicity, fatigue and/or finger numbness or tumbling.
  • Patients of child-bearing potential must agree to use a medically approved contraception method until at least six weeks after the last study drug administration.
  • Known deleterious germline mutation of BRCA1/2 (Patients in Cohorts A and A1)
  • Prior treatment with PARP inhibitors (Patients in Cohort A1)

You may not qualify if:

  • Prior treatment with PM01183 or trabectedin.
  • Extensive prior RT.
  • Prior or concurrent malignant disease unless cured for more than five years.
  • Exceptions are breast cancer in the other breast.
  • Uncommon or rare subtypes of breast cancer.
  • Symptomatic or progressive brain metastases.
  • Bone-limited and exclusively metastases.
  • Relevant diseases or clinical situations which may increase patient's risk:
  • History of cardiac disease. Moderate breathing difficulties or oxygen requirement Active uncontrolled infection. Unhealed wound or presence of any external drainage. Chronically active viral hepatitis. Immunocompromised patients, including those known to be infected by human immunodeficiency virus (HIV).
  • Known muscular disease or functional alteration
  • Pregnant or breastfeeding women.
  • Impending need for immediate RT for symptomatic relief.
  • Limitation of the patient's ability to comply with the treatment or to follow-up the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Stanford Women's Cancer Center

Stanford, California, 94305, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Weill Cornell Medical College - New York Presbyterian Hospital

New York, New York, 10065, United States

Location

Abramson Cancer Center - Hospital of the University of Pennsylvania at Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Complexo Hospitalario Universitario A Coruña

A Coruña, A Coruña, 15006, Spain

Location

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Related Publications (2)

  • Fernandez-Teruel C, Lubomirov R, Fudio S. Population Pharmacokinetic-Pharmacodynamic Modeling and Covariate Analyses of Neutropenia and Thrombocytopenia in Patients With Solid Tumors Treated With Lurbinectedin. J Clin Pharmacol. 2021 Sep;61(9):1206-1219. doi: 10.1002/jcph.1886. Epub 2021 Jun 9.

    PMID: 33914350DERIVED

  • Cruz C, Llop-Guevara A, Garber JE, Arun BK, Perez Fidalgo JA, Lluch A, Telli ML, Fernandez C, Kahatt C, Galmarini CM, Soto-Matos A, Alfaro V, Perez de la Haza A, Domchek SM, Antolin S, Vahdat L, Tung NM, Lopez R, Arribas J, Vivancos A, Baselga J, Serra V, Balmana J, Isakoff SJ. Multicenter Phase II Study of Lurbinectedin in BRCA-Mutated and Unselected Metastatic Advanced Breast Cancer and Biomarker Assessment Substudy. J Clin Oncol. 2018 Nov 1;36(31):3134-3143. doi: 10.1200/JCO.2018.78.6558. Epub 2018 Sep 21.

    PMID: 30240327DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

PM 01183

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Pharma Mar S.A.
Organization
Pharma Mar S.A.
clinicaltrials@pharmamar.com
00 34 91846 60 00

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2012

First Posted

February 3, 2012

Study Start

June 13, 2012

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

September 25, 2020

Results First Posted

September 25, 2020

Record last verified: 2018-11

Locations

US(5)ES(4)