A Phase II Clinical Trial of PXD101 in Patients with Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas

• Register: EUCTR
• Last refreshed on: 4 April 2022
• Main ID: EUCTR2007-001396-11-FR
• Date of registration: 18/05/2007
• Prospective Registration: Yes
• Primary sponsor: CuraGen Corporation
• Public title: A Phase II Clinical Trial of PXD101 in Patients with Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas
• Scientific title: A Phase II Clinical Trial of PXD101 in Patients with Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas
• Date of first enrolment: 18/09/2007
• Target sample size: 68
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001396-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

France, Germany

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female with age = 18 years.
2. A histologically confirmed diagnosis of CTCL or PTCL or other T-cell NHL(WHO/Revised European-American Lymphoma classification). ALCL patients
presenting with CD30+, alk-, and no extracutaneous involvement (i.e. confirmed
absence of systemic disease) will be enrolled in the CTCL arm
3. Patients must have failed at least one line of prior systemic therapy, and there is no limitation in number of prior therapies. For CTCL, patients who are refractory or
intolerant to oral Targretin are also eligible.
4. The presence of measurable disease (defined as = 1 cm with radiographic imaging) for PTCL or stage 1B or greater disease for CTCL and assessable by the severityweighted assessment tool (SWAT).
5. Patients must have had a chest x-ray, CT scan or CT/PET scan or SWAT assessment within 2 weeks prior to enrollment for CTCL patients or within 4 weeks prior to enrollment for PTCL patients and after completion of any prior cytotoxic
chemotherapy. Patients with a history of bone marrow involvement must have a bone marrow biopsy within 4 weeks of study enrollment.
6. Adequate bone marrow and hepatic function including the following:
a. WBC = 3,000 cells/mm3, absolute neutrophil count = 1,500 cells/mm3, platelets
= 50,000/mm3
b. Total bilirubin =1.5 x upper normal limit.
c. AST (SGOT), ALT (SGPT) and alkaline phosphatase =2.5 x upper normal limit
d. Hemoglobin = 9.0 g/dL.
7. Serum potassium within normal range.
8. Karnofsky performance status > 70%.
9. Estimated life expectancy greater than 3 months.
10. Signed informed consent approved by the Institutional Review Board.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Patients who have received anticancer therapies within 4 weeks of first PXD101
administration should be excluded unless toxicity from prior anticancer therapy has
resolved or returned to baseline and cancer disease status warrants. The exception is patients who have received alemtuzumab; these patients are excluded if they have received alemtuzumab within one year of first PXD101 administration.
2. Any use of investigational drugs within 4 weeks prior to study registration.
3. Major surgery within 4 weeks of study drug administration.
4. Prior allogenic bone marrow transplant.
5. A diagnosis of Adult T-cell lymphoma/leukemia (ATLL) or Precursor Tlymphoblastic
lymphoma.
6. Co-existing active infection or any co-existing medical condition likely to interfere
with trial procedures. However, patients with progressing CTCL whose open skin
lesions are frequently infected may not be excluded from this trial at the discretion of
Investigators.
7. Clinically significant cardiovascular disease including unstable angina pectoris,
uncontrolled hypertension, and congestive heart failure related to primary cardiac
disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular
heart disease, a myocardial infarction within 6 months or a Left Ventricular Ejection
Fraction (LVEF) < 40% (by Echocardiogram (ECHO) or Multiple Gated Acquisition
Scan (MUGA)) within 3 months of study enrollment.
8. A marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval >500 msec; Long QT Syndrome; the required use of concomitant
medication on PXD101 infusion days that may cause Torsade de Pointes.
9. Patients with renal insufficiency defined as a calculated creatinine clearance of <45
mL/min/1.73 m2 based on Cockroft and Gault’s method (Cockroft 1976) or an
alternative calculation method used locally.
10. Patients with a history of allergic reactions attributed to compounds of similar
chemical or biological composition to PXD101 and L-arginine.
11. Clinically significant central nervous system disorders with altered mental status or psychiatric disorders precluding understanding of the informed consent process
and/or completion of the necessary studies.
12. Other malignant diseases requiring treatment and patients who are less than 5 years post-treatment completion for an invasive malignant disease (except for nonmelanotic skin cancers or cervical cancer in-situ.) Patients with any history of
melanoma should be excluded.
13. Pregnant or breast-feeding women and women of childbearing age and potential,
who are not willing to use effective contraception. Male patients and/or their fertile
female partners who are not willing to use contraceptives during the trial.
14. Known active infection with HIV, HTLV-1, hepatitis B or hepatitis C.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

T-cell Lymphoma
MedDRA version: 9.1 Level: LLT Classification code 10042971 Term: T-cell lymphoma

Intervention(s)

Product Name: PXD101
Product Code: PXD101
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 414864-00-9
Current Sponsor code: PXD101
Other descriptive name: Belinostat
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Secondary Objective: To determine the efficacy parameters duration of response, time to response, and time to progression, plus to examine safety following PXD101 therapy as a single agent.

Main Objective: To determine the efficacy of PXD101 treatment as measured by objective response rate. Objective response (OR) is best overall response of CR or PR. CTCL response assessment is based on the severity-weighted assessment tool (SWAT) (Stevens 2002) with Cheson criteria applied in addition for determination of PD. PTCL response will be assessed using the criteria of Cheson et al. (Cheson 2007).

Primary end point(s): Exhibiting Objective Response or Stable Disease as confirmed by severity assessment tool.

Secondary ID(s)

PXD101-CLN-6

Ethics review

Status: Approved
Approval date: 18/09/2007
Contact:

Results

• Results available: Yes
• Date Posted: 12/08/2016
• Date Completed: 16/07/2009
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-001396-11/results