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NCT Number: NCT01970553

Escalating Doses of PM01183 in Combination With Gemcitabine in Patients With Specific Unresectable Solid Tumors

Phase I multicenter, open-label, clinical and pharmacokinetic study of PM01183 in combination with gemcitabine in non-heavily pretreated patients with selected advanced solid tumors to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with gemcitabine, to characterize the safety profile and feasibility of this combination in patients with selected advanced solid tumors, to characterize the pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity in non-heavily pretreated selected solid tumor patients and to evaluate the pharmacogenomics (PGx) in tumor samples of patients exposed, in order to assess potential markers of response and/or resistance.

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Key information

Conditions

Specific Advanced Solid Tumors Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital Universitario Madrid Sanchinarro, Madrid, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntarily written informed consent
  • Age: between 18 and 75 years (both inclusive)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
  • Life expectancy ≥ 3 months
  • Patients with a histologically/cytologically confirmed diagnosis of advanced disease of any of the following tumors:
  • Breast cancer
  • Epithelial ovarian cancer (including primary peritoneal disease and/or fallopian tube carcinomas and/or endometrial adenocarcinomas)
  • Stromal uterine sarcomas
  • Non-small cell lung cancer (NSCLC)
  • Platinum-refractory or relapsed germ cell tumors
  • Adenocarcinoma of the exocrine pancreas
  • Biliary tract adenocarcinoma
  • Adenocarcinoma or carcinoma of unknown primary site
  • Advanced or unresectable mesothelioma
  • At least three weeks since the last anticancer therapy,including radiation therapy (RT)
  • Adequate bone marrow, renal, hepatic, and metabolic function
  • Left ventricular ejection fraction (LVEF) by echocardiography (ECHO) or multiple-gated acquisition (MUGA) within normal range (according to institutional standards).
  • Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for six weeks after discontinuation of treatment.

Exclusion criteria

  • Concomitant diseases/conditions:
  • History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within last year.
  • Symptomatic or any uncontrolled arrhythmia
  • Ongoing chronic alcohol consumption, or cirrhosis
  • Active uncontrolled infection.
  • Known human immunodeficiency virus (HIV) infection.
  • Any other major illness that, in the Investigator's judgment
  • Brain metastases or leptomeningeal disease involvement
  • Men or women of childbearing potential who are not using an effective method of contraception
  • Patients who have had radiation therapy in more than 35% of the bone marrow
  • History of previous bone marrow and/or stem cell transplantation
  • Prior treatment with gemcitabine-containing therapy for advanced disease

Treatment and study plan

lurbinectedin (PM01183)

Drug

lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials

Gemcitabine

Drug

1000 mg vial, powder for injectable solution

Primary outcomes

  1. Recommended Dose (RD)

    Time frame: 19 months

    The RD will be the highest dose level explored at which less than one third of evaluable patients experience a DLT during Cycle 1.

Secondary outcomes

  1. Pharmacokinetics (PK) characterisation

    Time frame: 19 months

    The dose-exposure relationships for maximum plasma concentration (Cmax) and area under the curve (AUC) will be evaluated.

  2. Preliminary antitumor efficacy

    Time frame: 29 months

    To obtain preliminary information on the clinical antitumor activity of this combination in non-heavily pretreated selected solid tumor patients

  3. Pharmacogenomics (PGx)

    Time frame: 29 months

    to identify molecular markers whose expression may be associated with the clinical outcome of patients. These molecular markers might allow the identification of those patients who will benefit from PM01183 and gemcitabine treatment, thus improving the health care by an individualized medicine.

Sponsors and collaborators

Lead sponsor

PharmaMar

Industry

Registry information

Official study title

Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 in Combination With Gemcitabine in Non-heavily Pretreated Patients With Selected Advanced Solid Tumors

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 28, 2013
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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