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Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination With Weekly Paclitaxel, With or Without Bevacizumab, in Patients With Selected Advanced Solid Tumors


Phase 1
18 Years
75 Years
Not Enrolling
Both
Breast Cancer, Ovarian Cancer, Gynecological Cancer, Head and Neck Carcinoma, Non-small Cell Lung Cancer, Small Cell Lung Cancer, Non-squamous Cell Lung Cancer

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Trial Information

Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination With Weekly Paclitaxel, With or Without Bevacizumab, in Patients With Selected Advanced Solid Tumors


Clinical trial to determine the maximum tolerated dose (MTD) and the recommended dose (RD)
of PM01183 in combination with weekly paclitaxel, with or without bevacizumab. Once a
recommended dose is defined for the PM01183 and weekly paclitaxel combination, the
feasibility of adding bevacizumab to this combination will be explored in a selected cohort
of patients to characterize the safety profile and feasibility of this combination, to
obtain preliminary information on antitumor activity, to obtain preliminary information on
quality of life (QoL), to characterize the pharmacokinetics (PK) of this combination and to
detect major drug-drug PK interactions and PK/PD (pharmacokinetic/pharmacodynamic)
correlation and to conduct an exploratory pharmacogenomic(PGx) analysis in patients with
selected advanced solid tumors.


Inclusion Criteria:



- Voluntarily signed and dated written informed consent

- Age between 18 and 75 years old (both inclusive)

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 1

- Life expectancy ≥ 3 months.

- Patients with a histologically/cytologically confirmed diagnosis of advanced and/or
unresectable disease of any of the following tumors:

1. Breast cancer

2. Epithelial ovarian cancer or gynecological cancer

3. Head and neck squamous cell carcinoma

4. Non-small cell lung cancer

5. Small cell lung cancer

6. Platinum-refractory germ-cell tumors.

7. Adenocarcinoma or carcinoma of unknown primary site

- Adequate bone marrow, renal, hepatic, and metabolic function

- Recovery to grade ≤ 1 or to baseline from any AE derived from previous treatment
(excluding alopecia of any grade).

- Pre-menopausal women must have a negative pregnancy test before study entry and agree
to use a medically acceptable method of contraception throughout the treatment period
and for at least six weeks after treatment discontinuation

Exclusion Criteria:

- Prior treatment with PM01183 or weekly paclitaxel or nanoalbumin-paclitaxel

- Patients who have previously discontinued paclitaxel-based regimes due to drug
related toxicity.

- Known hypersensitivity to bevacizumab or any component of its formulation

- Patients who have previously discontinued bevacizumab-containing regimes due to
drug-related toxicity.

- More than three prior lines of chemotherapy

- Less than three months since last taxane-containing therapy.

- Wash-out period:

1. Less than three weeks since the last chemotherapy-containing regimen

2. Less than three weeks since the last radiotherapy dose

3. Less than four weeks since last monoclonal antibody-containing therapy

- Concomitant diseases/conditions:

Unstable angina, myocardial infarction, valvular heart disease, encephalopathy, ischemic
attacks, hemorrhagic or ischemic cerebrovascular accident (CVA) or ongoing pulmonary
embolism within last year, arrhythmia, hepatopathy, uncontrolled infection, hemoptysis or
oxygen requiring dyspnea, known HIV infection, bleeding risk, muscular problems,
peripheral neuropathy, Symptomatic or progressive brain metastases or leptomeningeal
disease.

- Men or pre-menopausal women who are not using an effective method of contraception as
previously described; actively breast feeding women.

- Patients who have pelvic irradiation with doses ≥ 45 Grays (Gy).

- History of previous bone marrow and/or stem cell transplantation.

- Confirmed bone marrow involvement

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose (MTD) and the recommended dose (RD)

Outcome Description:

To determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with weekly paclitaxel, with or without bevacizumab, in patients with selected advanced solid tumors.

Outcome Time Frame:

Around 24 months from the begining of the study

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

PM1183-A-007-13

NCT ID:

NCT01831089

Start Date:

September 2013

Completion Date:

June 2016

Related Keywords:

  • Breast Cancer
  • Ovarian Cancer
  • Gynecological Cancer
  • Head and Neck Carcinoma
  • Non-Small Cell Lung Cancer
  • Small Cell Lung Cancer
  • Non-squamous Cell Lung Cancer
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Ovarian Neoplasms
  • Small Cell Lung Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021