NCT00884845

Brief Summary

Phase I multicenter, open-label, dose-escalating clinical and pharmacokinetic trial of PM02734 administered in combination with erlotinib to determine the safety and tolerability and to identify the dose limiting toxicity (DLT) and the recommended dose (RD) of the combination of PM02734 and erlotinib, in patients with advanced malignant solid tumors.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2009

Typical duration for phase_1

Geographic Reach
2 countries

3 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

Study Start

First participant enrolled

January 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 26, 2014

Status Verified

March 1, 2014

Enrollment Period

2.4 years

First QC Date

April 16, 2009

Last Update Submit

March 25, 2014

Conditions

Advanced Malignant Solid Tumors

Keywords

PM2734TumorsPharmaMarErlotinibTarceva

Outcome Measures

Primary Outcomes (1)

  • To determine the safety and tolerability and to identify the dose limiting toxicity (DLT) and the recommended dose (RD) of the combination of PM02734 and erlotinib

    2 years

Secondary Outcomes (1)

  • To determine preliminary: pharmacokinetics (PK) , PK / pharmacodynamic correlation, antitumor activity, pharmacogenomic (PGx) study to explore molecular predictors of response.

    2 years

Study Arms (1)

Arm 1

EXPERIMENTAL

Administration of i.v. infusions of PM02734 (on Days 1, 8 and 15) every three weeks and a daily oral dose of erlotinib

Drug: PM02734 and erlotinibDrug: Erlotinib

Interventions

PM02734 and erlotinibDRUG

PM02734 drug product (DP) 1 mg/vial is a powder for concentrate for solution for infusion

Arm 1
ErlotinibDRUG

Erlotinib is provided as 25 mg, 100 mg and 150 mg white film-coated tablets

Also known as: Brand name: TARCEVA
Arm 1

Eligibility Criteria

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

You may qualify if:

  • Voluntary written informed consent form.
  • Histologically or cytologically confirmed advanced malignant solid tumors.
  • Measurable or non-measurable disease following (RECIST)
  • Age ≥ 18 years.
  • Life expectancy ≥ 3 months.
  • Performance status ECOG ≤ 2.
  • Recovery from any drug-related adverse events (AEs) derived from previous treatments.
  • Appropriate bone marrow, liver and renal function.
  • Left ventricular ejection fraction (LVEF) within normal limits for the institution.
  • Women of childbearing potential must have a negative serum pregnancy test before study entry. Both men and women must agree to use a medically acceptable method of contraception throughout the treatment period and for three months after discontinuation of treatment.

You may not qualify if:

  • Prior therapy with PM02734.
  • Pregnant or lactating women.
  • Less than four weeks from radiation therapy.
  • Evidence of progressive central nervous system (CNS) metastases. or any symptomatic brain or leptomeningeal metastases.
  • Other relevant diseases or adverse clinical conditions.
  • Any other major illness that, in the Investigator's judgment.
  • Limitation of the patient's ability to comply with the treatment or to follow-up at a participating protocol.
  • Ingestion of potent cytochrome CYP3A4 inhibitors.
  • Treatment with any investigational product in the 30-day period prior to the first infusion.
  • Known hypersensitivity to any component of PM02734 or erlotinib.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Montefiore Medical Center

New York, New York, 10467-2490, United States

Location

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Intituto Universitario Dexeus

Barcelona, Barcelona, 08020, Spain

Location

MeSH Terms

Conditions

Neoplasms

Interventions

elisidepsinErlotinib Hydrochloride

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Roman Pérez-Soler, M.D.

    Montefiore Medical Center (NY - USA)

    PRINCIPAL INVESTIGATOR

  • Rafael Rosell, M.D.

    Hospital Universitario Germans Trias i Pujol (Badalona - Spain)

    PRINCIPAL INVESTIGATOR

  • Mauricio Cuello, M.D.

    Instituto Universitario Dexeus (Barcelona - Spain)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2009

First Posted

April 21, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 26, 2014

Record last verified: 2014-03

Locations

ES(2)US(1)