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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	26 February 2018
Main ID:	EUCTR2010-022036-36-IT
Date of registration:	22/02/2011
Prospective Registration:	No
Primary sponsor:	Pfizer Inc., 235 East 42nd Street, New York, NY 10017
Public title:	A Phase 1 trial of pf-03084014 in patients with advanced solid tumor malignancy and t-cell acute lymphoblastic leukemia/lymphoblastic lymphoma - ND
Scientific title:	A Phase 1 trial of pf-03084014 in patients with advanced solid tumor malignancy and t-cell acute lymphoblastic leukemia/lymphoblastic lymphoma - ND
Date of first enrolment:	15/02/2011
Target sample size:	60
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022036-36
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no
Phase:	Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment
Italy

Contacts

Name:
Address:
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Email:
Affiliation:

Name:
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Key inclusion & exclusion criteria

Inclusion criteria:
Patients with acute T-ALL/LBL that are refractory/resistant to current treatment options or for which no standard therapy is available.
Are the trial subjects under 18? yes
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:
Prior treatment with a gamma secretase inhibitor or an anti-Notch receptor antibody for treatment of cancer

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

Health Condition(s) or Problem(s) studied

advanced solid tumor malignancies or relapsed or refractory acute T-cell lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL).
MedDRA version: 9.1 Level: LLT Classification code 10066110
MedDRA version: 9.1 Level: LLT Classification code 10065252
MedDRA version: 9.1 Level: LLT Classification code 10065923

Intervention(s)

Product Code: PF-03084014
Pharmaceutical Form: Tablet
Current Sponsor code: PF-03084014
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Product Code: PF-03084014
Pharmaceutical Form: Tablet
Current Sponsor code: PF-03084014
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Code: PF-03084014
Pharmaceutical Form: Tablet
Current Sponsor code: PF-03084014
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Pharmaceutical Form: Tablet
INN or Proposed INN: Dexamethasone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-

Primary Outcome(s)

Main Objective: Phase 1a Primary Objectives 1. To determine the maximum tolerated dose (MTD) of PF-03084014 when administered twice daily for 21 days alone in patients with advanced malignancies (encompassing advanced solid tumors and relapsed or refractory T-ALL/LBL). Phase 1b Primary Objectives 1. To determine the MTD of PF-03084014 when administered twice daily for 21 days in combination with dexamethasone given once daily on Day 1 to Day 3 and Day 11 to Day 13 of each cycle in patients with advanced malignancies (encompassing advanced solid tumors and relapsed or refractory T-ALL/LBL).

Primary end point(s): First cycle dose limiting toxicities (DLT).

Secondary Objective: Phase 1a Secondary Objectives 1. To evaluate the safety and tolerability of PF-03084014 when administered twice daily for 21 days in patients with advanced malignancies. 2. To characterize single-dose and multiple-dose pharmacokinetics (PK) of PF-03084014, including the effect of food on PK, in patients with advanced solid tumors. 3. To evaluate the pharmacodynamics of PF-03084014 in patients with advanced malignancies. 4. To document any anti-tumor activity with PF-03084014, alone, in patients with advanced malignancies. 5. To characterize the effects of PF-03084014 on QTc. 6. To evaluate mechanisms of sensitivity and resistance to PF-03084014 in patients with advanced malignancies. Phase 1b Secondary Objectives 1. To evaluate the safety and tolerability of PF-03084014 when administered twice dailyvfor 21 days in combination with dexamethasone given once daily on Day 1 to Day 3vand Day 11 to Day 13 of each cycle in patientsvwith advanced malignancies. 2. To characteri

Secondary Outcome(s)

Secondary ID(s)

A8641014

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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