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Clinical Trial Results:
PAZOPANIB Efficacy and Tolerance in Desmoids Tumors : Phase 2 Clinical Trial (DESMOPAZ)

Summary
EudraCT number	2011-006037-42
Trial protocol	FR
Global end of trial date	15 Jul 2019

Results information
Results version number	v1(current)
This version publication date	24 Mar 2022
First version publication date	24 Mar 2022
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

IB2011-03

ISRCTN number

US NCT number

NCT01876082

WHO universal trial number (UTN)

Sponsor organisation name

Institut Bergonié

Sponsor organisation address

229 cours de l'Argonne, Bordeaux, France, 33076

Public contact

Regulatory Affairs Management Desk, Institut Bergonié, drci@bordeaux.unicancer.fr

Scientific contact

Regulatory Affairs Management Desk, Institut Bergonié, drci@bordeaux.unicancer.fr

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

05 Oct 2020

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

15 Jul 2019

Was the trial ended prematurely?

Main objective of the trial

Efficacy evaluation in terms of non progression rate at 6 months of treatment with Pazopanib and methotrexate-vinblastine.

Protection of trial subjects

A supervisory committee is constitued to review the patient ellibility, ensure the patient protetion and evaluate the benefit/risk ratio. An IDMC is constitued to review the intermediary analysis and evaluate the safety and the efficacy

Background therapy

Evidence for comparator

Actual start date of recruitment

13 Sep 2012

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

France: 72

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

Age ≥ 18 years; ECOG ≤ 1; Histologically confirmed desmoid tumor; Disease progression before the patient's inclusion : completion of two similar imaging obtained within 6 months apart (a tolerance of 6 weeks is accepted) Measurable target lesion (RECIST criteria) ;

Period 1 title

Overall period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

PAZOPANIB

Arm description

After inclusion and screening, patients received pazopanib 800 mg per day orally for up to 1 year.

Arm type

Experimental

Investigational medicinal product name

Pazopanib

Investigational medicinal product code

Other name

Pharmaceutical forms

Buccal tablet

Routes of administration

Oral use

Dosage and administration details

• 800 mg per day • oral administration • at least 1 hour before or 2 hours after a meal, • until disease progression or for 12 months maximum

Vinblastine and Methotrexate

Arm description

Intravenous methotrexate (30 mg/m²) plus vinblastine (5 mg/m²), once a week for 6 months and then every 2 weeks for 6 months.

Arm type

Control

Investigational medicinal product name

Vinblastine and Methotrexate

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

vinblastine 5 mg / m² and methotrexate 30 mg / m²(D1, D8, D15, D21, 6 months and then D1, D15) 28 days per cycle until disease progression or for 12 months.

Number of subjects in period 1	PAZOPANIB	Vinblastine and Methotrexate
Started	48	24
Completed	46	20
Not completed	2	4
Consent withdrawn by subject	-	2
Adverse event, non-fatal	1	1
treatment interruption >= 21 days (cycle 1)	-	1
Protocol deviation	1	-

Baseline characteristics

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Reporting group title

PAZOPANIB

Reporting group description

After inclusion and screening, patients received pazopanib 800 mg per day orally for up to 1 year.

Reporting group title

Vinblastine and Methotrexate

Reporting group description

Intravenous methotrexate (30 mg/m²) plus vinblastine (5 mg/m²), once a week for 6 months and then every 2 weeks for 6 months.

Reporting group values	PAZOPANIB	Vinblastine and Methotrexate	Total
Number of subjects	48	24	72
Age categorical
Units: Subjects
In utero			0
Preterm newborn infants (gestational age < 37 wks)			0
Newborns (0-27 days)			0
Infants and toddlers (28 days-23 months)			0
Children (2-11 years)			0
Adolescents (12-17 years)			0
Adults (18-64 years)			0
From 65-84 years			0
85 years and over			0
Age continuous
Units: years
median (full range (min-max))	35.5 (30.6 to 56.0)	42.5 (30.5 to 54.0)	-
Gender categorical
Units: Subjects
Female	31	15	46
Male	17	9	26

End points

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Reporting group title

PAZOPANIB

Reporting group description

After inclusion and screening, patients received pazopanib 800 mg per day orally for up to 1 year.

Reporting group title

Vinblastine and Methotrexate

Reporting group description

Intravenous methotrexate (30 mg/m²) plus vinblastine (5 mg/m²), once a week for 6 months and then every 2 weeks for 6 months.

Primary: Percentage of Patients Remaining Alive and Progression-free at 6 Months as per RECIST 1.1 After the Day of Randomisation (6-month Non-progression Rate).

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End point title

Percentage of Patients Remaining Alive and Progression-free at 6 Months as per RECIST 1.1 After the Day of Randomisation (6-month Non-progression Rate). ^[1]

End point description

Percentage of patients remaining alive and progression-free at 6 months as per RECIST 1.1 after the day of randomisation. Progression is defined using New Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), or a unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.

End point type

Primary

End point timeframe

6 months

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was performed since this trial is non comparative

End point values	PAZOPANIB	Vinblastine and Methotrexate
Number of subjects analysed	46	20
Units: Percentage of patients
number (confidence interval 95%)	84.8 (71.1 to 93.7)	45.0 (23.1 to 68.5)

No statistical analyses for this end point

Secondary: Overall survival rate at 2 years

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End point title

Overall survival rate at 2 years

End point description

Overall survival (OS) defined as the time from randomization to death (due to any cause). Patients alive were censored at the date of last follow-up or last patient contact. Overall survival was estimated as a function of time using Kaplan-Meier method.1- and 2-Year OS rates were reported.

End point type

Secondary

End point timeframe

Randomization to disease progression, or death due to any cause, whichever occurs first; until 2 years after the last patient randomized.

End point values	PAZOPANIB	Vinblastine and Methotrexate
Number of subjects analysed	46	20
Units: Percentage of participants
number (confidence interval 95%)	97.8 (85.6 to 99.7)	100 (100 to 100)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

The adverse events are reported from the signature of the informed consent form to 30 days after the patient study end participation

Adverse event reporting additional description

Adverse events (AEs) were graded and coded according to the CTCAE V4.0.

Assessment type

Systematic

Dictionary name

CTCAE

Dictionary version

4.0

Reporting group title

PAZOPANIB

Reporting group description

After inclusion and screening, patients received pazopanib 800 mg per day orally for up to 1 year.

Reporting group title

Vinblastine and Methotrexate

Reporting group description

Intravenous methotrexate (30 mg/m²) plus vinblastine (5 mg/m²), once a week for 6 months and then every 2 weeks for 6 months.

Serious adverse events	PAZOPANIB	Vinblastine and Methotrexate
Total subjects affected by serious adverse events
subjects affected / exposed	20 / 48 (41.67%)	10 / 22 (45.45%)
number of deaths (all causes)	1	0
number of deaths resulting from adverse events	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
subjects affected / exposed	1 / 48 (2.08%)	0 / 22 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Additional description: 1 SAE LOCAL TUMOR BLEEDING 1 SAE LOSS OF TUMOR SUBSTANCE
subjects affected / exposed	1 / 48 (2.08%)	0 / 22 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Hematoma
subjects affected / exposed	1 / 48 (2.08%)	0 / 22 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	2 / 48 (4.17%)	0 / 22 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thromboembolic event
subjects affected / exposed	1 / 48 (2.08%)	1 / 22 (4.55%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
Surgical and medical procedures - Other, specify
Additional description: MEATOPLASTY
subjects affected / exposed	1 / 48 (2.08%)	0 / 22 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Fever
subjects affected / exposed	1 / 48 (2.08%)	0 / 22 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infusion site extravasation
subjects affected / exposed	0 / 48 (0.00%)	1 / 22 (4.55%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions - Other, specify
Additional description: HOSPITALIZATION FOR CRYOTHERAPY
subjects affected / exposed	1 / 48 (2.08%)	0 / 22 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
Additional description: HEMOPTYSIS
subjects affected / exposed	1 / 48 (2.08%)	0 / 22 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Depression
subjects affected / exposed	0 / 48 (0.00%)	1 / 22 (4.55%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	0 / 48 (0.00%)	2 / 22 (9.09%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Neutrophil count decreased
subjects affected / exposed	2 / 48 (4.17%)	1 / 22 (4.55%)
occurrences causally related to treatment / all	2 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Fracture
subjects affected / exposed	1 / 48 (2.08%)	0 / 22 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Paresthesia
subjects affected / exposed	1 / 48 (2.08%)	0 / 22 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders - Other, specify
Additional description: PARKINSON'S DISEASE AGGRAVATION
subjects affected / exposed	0 / 48 (0.00%)	1 / 22 (4.55%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Anemia
subjects affected / exposed	11 / 48 (22.92%)	0 / 22 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders - Other, specify
Additional description: POLYCYTHEMIA
subjects affected / exposed	1 / 48 (2.08%)	0 / 22 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Retinal detachment
subjects affected / exposed	1 / 48 (2.08%)	0 / 22 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	1 / 48 (2.08%)	2 / 22 (9.09%)
occurrences causally related to treatment / all	1 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhea
subjects affected / exposed	1 / 48 (2.08%)	0 / 22 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal stenosis
subjects affected / exposed	0 / 48 (0.00%)	1 / 22 (4.55%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal pain
subjects affected / exposed	1 / 48 (2.08%)	0 / 22 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders - Other, specify
Additional description: FOOD POISONING
subjects affected / exposed	1 / 48 (2.08%)	0 / 22 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
Additional description: 1 SAE ACUTE HEPATIC CYTOLYSIS 1 SAE HEPATIC CYTOLYSIS
subjects affected / exposed	0 / 48 (0.00%)	2 / 22 (9.09%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Sepsis
subjects affected / exposed	1 / 48 (2.08%)	0 / 22 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Hypercalcemia
subjects affected / exposed	1 / 48 (2.08%)	0 / 22 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myalgia
subjects affected / exposed	0 / 48 (0.00%)	1 / 22 (4.55%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	PAZOPANIB	Vinblastine and Methotrexate
Total subjects affected by non serious adverse events
subjects affected / exposed	48 / 48 (100.00%)	22 / 22 (100.00%)
Vascular disorders
Hot flashes
subjects affected / exposed	5 / 48 (10.42%)	0 / 22 (0.00%)
occurrences all number	5	0
Hypertension
subjects affected / exposed	22 / 48 (45.83%)	0 / 22 (0.00%)
occurrences all number	27	0
General disorders and administration site conditions
Edema limbs
subjects affected / exposed	3 / 48 (6.25%)	1 / 22 (4.55%)
occurrences all number	3	2
Fatigue
subjects affected / exposed	40 / 48 (83.33%)	20 / 22 (90.91%)
occurrences all number	45	19
Fever
subjects affected / exposed	3 / 48 (6.25%)	2 / 22 (9.09%)
occurrences all number	4	2
Flu like symptoms
subjects affected / exposed	3 / 48 (6.25%)	1 / 22 (4.55%)
occurrences all number	3	1
Non-cardiac chest pain
subjects affected / exposed	2 / 48 (4.17%)	2 / 22 (9.09%)
occurrences all number	2	2
Pain
subjects affected / exposed	4 / 48 (8.33%)	2 / 22 (9.09%)
occurrences all number	4	2
Reproductive system and breast disorders
Uterine hemorrhage
subjects affected / exposed	3 / 48 (6.25%)	0 / 22 (0.00%)
occurrences all number	4	0
Respiratory, thoracic and mediastinal disorders
Dyspnea
subjects affected / exposed	4 / 48 (8.33%)	0 / 22 (0.00%)
occurrences all number	4	0
Epistaxis
subjects affected / exposed	4 / 48 (8.33%)	0 / 22 (0.00%)
occurrences all number	4	0
Respiratory, thoracic and mediastinal disorders - Other, specify
subjects affected / exposed	3 / 48 (6.25%)	0 / 22 (0.00%)
occurrences all number	3	0
Psychiatric disorders
Anxiety
subjects affected / exposed	4 / 48 (8.33%)	1 / 22 (4.55%)
occurrences all number	4	1
Insomnia
subjects affected / exposed	5 / 48 (10.42%)	1 / 22 (4.55%)
occurrences all number	6	1
Psychiatric disorders - Other, specify
subjects affected / exposed	4 / 48 (8.33%)	0 / 22 (0.00%)
occurrences all number	4	0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	15 / 48 (31.25%)	7 / 22 (31.82%)
occurrences all number	16	8
Aspartate aminotransferase increased
subjects affected / exposed	12 / 48 (25.00%)	4 / 22 (18.18%)
occurrences all number	12	4
Blood bilirubin increased
subjects affected / exposed	3 / 48 (6.25%)	2 / 22 (9.09%)
occurrences all number	3	2
GGT increased
subjects affected / exposed	3 / 48 (6.25%)	3 / 22 (13.64%)
occurrences all number	8	3
Investigations - Other, specify
subjects affected / exposed	6 / 48 (12.50%)	0 / 22 (0.00%)
occurrences all number	8	0
Neutrophil count decreased
subjects affected / exposed	4 / 48 (8.33%)	10 / 22 (45.45%)
occurrences all number	5	14
Platelet count decreased
subjects affected / exposed	5 / 48 (10.42%)	0 / 22 (0.00%)
occurrences all number	6	0
Weight loss
subjects affected / exposed	5 / 48 (10.42%)	2 / 22 (9.09%)
occurrences all number	6	2
Nervous system disorders
Dysesthesia
subjects affected / exposed	2 / 48 (4.17%)	0 / 22 (0.00%)
occurrences all number	2	0
Dysgeusia
subjects affected / exposed	13 / 48 (27.08%)	1 / 22 (4.55%)
occurrences all number	13	1
Headache
subjects affected / exposed	21 / 48 (43.75%)	4 / 22 (18.18%)
occurrences all number	32	5
Nervous system disorders - Other, specify
subjects affected / exposed	0 / 48 (0.00%)	2 / 22 (9.09%)
occurrences all number	0	2
Paresthesia
subjects affected / exposed	2 / 48 (4.17%)	6 / 22 (27.27%)
occurrences all number	2	6
Blood and lymphatic system disorders
Anemia
subjects affected / exposed	2 / 48 (4.17%)	5 / 22 (22.73%)
occurrences all number	2	7
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	16 / 48 (33.33%)	6 / 22 (27.27%)
occurrences all number	29	6
Bloating
subjects affected / exposed	4 / 48 (8.33%)	2 / 22 (9.09%)
occurrences all number	4	2
Constipation
subjects affected / exposed	6 / 48 (12.50%)	12 / 22 (54.55%)
occurrences all number	6	15
Diarrhea
subjects affected / exposed	37 / 48 (77.08%)	9 / 22 (40.91%)
occurrences all number	60	10
Dry mouth
subjects affected / exposed	4 / 48 (8.33%)	1 / 22 (4.55%)
occurrences all number	4	1
Gastroesophageal reflux disease
subjects affected / exposed	1 / 48 (2.08%)	2 / 22 (9.09%)
occurrences all number	1	2
Gastrointestinal disorders - Other, specify
subjects affected / exposed	9 / 48 (18.75%)	2 / 22 (9.09%)
occurrences all number	12	2
Gastrointestinal pain
subjects affected / exposed	8 / 48 (16.67%)	1 / 22 (4.55%)
occurrences all number	9	1
Mucositis oral
subjects affected / exposed	13 / 48 (27.08%)	7 / 22 (31.82%)
occurrences all number	17	11
Nausea
subjects affected / exposed	26 / 48 (54.17%)	16 / 22 (72.73%)
occurrences all number	34	19
Stomach pain
subjects affected / exposed	0 / 48 (0.00%)	4 / 22 (18.18%)
occurrences all number	0	4
Toothache
subjects affected / exposed	3 / 48 (6.25%)	1 / 22 (4.55%)
occurrences all number	3	3
Vomiting
subjects affected / exposed	15 / 48 (31.25%)	6 / 22 (27.27%)
occurrences all number	24	6
Skin and subcutaneous tissue disorders
Alopecia
subjects affected / exposed	6 / 48 (12.50%)	4 / 22 (18.18%)
occurrences all number	6	4
Dry skin
subjects affected / exposed	7 / 48 (14.58%)	0 / 22 (0.00%)
occurrences all number	8	0
Palmar-plantar erythrodysesthesia syndrome
subjects affected / exposed	16 / 48 (33.33%)	0 / 22 (0.00%)
occurrences all number	22	0
Pruritus
subjects affected / exposed	4 / 48 (8.33%)	1 / 22 (4.55%)
occurrences all number	4	2
Skin and subcutaneous tissue disorders - Other, specify
subjects affected / exposed	36 / 48 (75.00%)	3 / 22 (13.64%)
occurrences all number	50	3
Skin hypopigmentation
subjects affected / exposed	10 / 48 (20.83%)	0 / 22 (0.00%)
occurrences all number	10	0
Endocrine disorders
Hypothyroidism
subjects affected / exposed	12 / 48 (25.00%)	0 / 22 (0.00%)
occurrences all number	13	0
Eye disorders - Other, specify
subjects affected / exposed	7 / 48 (14.58%)	1 / 22 (4.55%)
occurrences all number	8	1
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	13 / 48 (27.08%)	2 / 22 (9.09%)
occurrences all number	17	2
Back pain
subjects affected / exposed	10 / 48 (20.83%)	1 / 22 (4.55%)
occurrences all number	11	1
Musculoskeletal and connective tissue disorder - Other, specify
subjects affected / exposed	6 / 48 (12.50%)	4 / 22 (18.18%)
occurrences all number	6	7
Myalgia
subjects affected / exposed	8 / 48 (16.67%)	5 / 22 (22.73%)
occurrences all number	9	6
Tumor pain
subjects affected / exposed	6 / 48 (12.50%)	0 / 22 (0.00%)
occurrences all number	6	0
Infections and infestations
Infections and infestations - Other, specify
subjects affected / exposed	8 / 48 (16.67%)	1 / 22 (4.55%)
occurrences all number	9	1
Tooth infection
subjects affected / exposed	4 / 48 (8.33%)	1 / 22 (4.55%)
occurrences all number	4	1
Urinary tract infection
subjects affected / exposed	3 / 48 (6.25%)	0 / 22 (0.00%)
occurrences all number	5	0
Metabolism and nutrition disorders
Anorexia
subjects affected / exposed	17 / 48 (35.42%)	5 / 22 (22.73%)
occurrences all number	21	5
Hypomagnesemia
subjects affected / exposed	3 / 48 (6.25%)	0 / 22 (0.00%)
occurrences all number	3	0

More information

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Were there any global substantial amendments to the protocol? Yes

04 Jul 2012

Protocol V3 dated 05-jun-2012

04 Feb 2013

Protocol V4 dated 23-oct-2012

28 Aug 2013

Protocol V5 dated 24-jul-2013

06 Dec 2013

Protocol V6 dated 07-aug-2013

02 May 2014

Protocol V7 dated 10-mar-2014

11 Sep 2015

Protocol V8 dated 10-jun-2015

19 May 2016

Protocol V9 dated 05-apr-2016

28 Nov 2016

Protocol V10 dated 19-aug-2016

10 Aug 2017

Protocol V11 dated 29-may-2017

08 Jan 2018

Protocol V12 dated 28-nov-2017

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
PAZOPANIB Efficacy and Tolerance in Desmoids Tumors : Phase 2 Clinical Trial (DESMOPAZ)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Patients Remaining Alive and Progression-free at 6 Months as per RECIST 1.1 After the Day of Randomisation (6-month Non-progression Rate).

Primary: Percentage of Patients Remaining Alive and Progression-free at 6 Months as per RECIST 1.1 After the Day of Randomisation (6-month Non-progression Rate).

Secondary: Overall survival rate at 2 years

Secondary: Overall survival rate at 2 years

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical trials

Clinical Trial Results: PAZOPANIB Efficacy and Tolerance in Desmoids Tumors : Phase 2 Clinical Trial (DESMOPAZ)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Patients Remaining Alive and Progression-free at 6 Months as per RECIST 1.1 After the Day of Randomisation (6-month Non-progression Rate).

Primary: Percentage of Patients Remaining Alive and Progression-free at 6 Months as per RECIST 1.1 After the Day of Randomisation (6-month Non-progression Rate).

Secondary: Overall survival rate at 2 years

Secondary: Overall survival rate at 2 years

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical Trial Results:
PAZOPANIB Efficacy and Tolerance in Desmoids Tumors : Phase 2 Clinical Trial (DESMOPAZ)