Study Escalating Doses of PM01183 in Combination With Fixed Doxorubicin in Patients With Specific Advanced Unresectable Solid Tumors

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-25

Study Completion Date

2017-08-09

Brief Summary

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Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 in Combination with Fixed Doxorubicin 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 doxorubicin, to characterize the safety profile and feasibility of this combination, to characterize the pharmacokinetics (PK) of this combination, to obtain preliminary information on the clinical antitumor activity,to explore the feasibility, safety and efficacy of a potential improvable dose of this combination in selected tumor types \[i.e. small cell lung cancer (SCLC) and endometrial cáncer\] and to evaluate the pharmacogenomics (PGx) in tumor samples of patients exposed to PM01183 and doxorubicin at the RD in order to assess potential markers of response and/or resistance.

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Detailed Description

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The study has currently met its primary end point and is now recruiting patients to be treated at the RD expansion cohort of selected tumor types, specifically: endometrial adenocarcinomas, neuroendocrine tumors, and small-cell lung cancer (SCLC).

Conditions

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Endometrial Adenocarcinomas Neuroendocrine Tumors Small-cell Lung Cancer With Less Than 2 Prior Cytotoxic-containing Lines of Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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lurbinectedin (PM01183) / doxorubicin

Group Type EXPERIMENTAL

lurbinectedin (PM01183)

Intervention Type DRUG

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

Doxorubicin

Intervention Type DRUG

Commercially available presentations of vials containing doxorubicin will be provided as appropriate.

Interventions

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lurbinectedin (PM01183)

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

Intervention Type DRUG

Doxorubicin

Commercially available presentations of vials containing doxorubicin will be provided as appropriate.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Voluntarily written informed consent
* Age: between 18 and 75 years (both inclusive).
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1. Cohort of patients with SCLC and endometrial cáncer ECOG PS ≤ 2.
* Life expectancy ≥ 3 months.
* Patients with a histologically/cytologically confirmed diagnosis of advanced disease of any of the following tumors:

1. Breast cancer
2. Soft-tissue sarcoma
3. Primary bone sarcomas.
4. Gynecologic tumors (endometrial adenocarcinomas, epithelial ovarian cancer...)
5. Hepatocellular carcinoma
6. Gastroenteropancreatic neuroendocrine tumors
7. Small cell lung cancer (SCLC)
8. Gastric cancer
9. Bladder cancer
10. Adenocarcinoma of unknown primary site
* At least three weeks since the last anticancer therapy, including radiotherapy
* Adequate bone marrow, renal, hepatic, and metabolic function
* Left ventricular ejection fraction (LVEF) by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan 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. This criterion will not apply to cohort of patients with SCLC and endometrial cáncer.
* History of previous bone marrow and/or stem cell transplantation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No