Phase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma

• Sponsor: Millennium Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00715208
• Collaborator: (none)
• Enrollment: 55
• Locations: 43
• Arms: 2
• Duration (Months): 29.9
• Patients Per Site: 1.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This is a phase 2, two-arm, non-randomized, open-label, multicenter study evaluating the safety and efficacy of 2 VELCADE-containing regimens. Patients will be treated with either a combination of VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone (VELCADE-R-CAP) or a combination of VELCADE, rituximab, cyclophosphamide, and prednisone (VELCADE-R-CP) based on investigator preference. Following completion of the treatment period, patients will receive maintenance therapy with rituximab up to a maximum of 2 years.

Condition or Disease	Intervention/Treatment	Phase
Relapsed Follicular Lymphoma	Drug: rituximab; Drug: cyclophosphamide; Drug: doxorubicin; Drug: VELCADE; Drug: prednisone	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Two-Arm, Non-Randomized, Multicenter, Phase 2 Study of VELCADE (Bortezomib) in Combination With Rituximab, Cyclophosphamide, and Prednisone With or Without Doxorubicin Followed by Rituximab Maintenance in Patients With Relapsed Follicular Lymphoma.
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VELCADE R-CAP VELCADE will be administered as a 3- to 5-second intravenous bolus injection, rituximab 375 mg/m2 Intravenous on Day 1, cyclophosphamide 750 mg/m2 intravenous on Day 1, doxorubicin 50 mg/m2 intravenous on Day 1, VELCADE 1.6 mg/m2 intravenous on Days 1 and 8, prednisone 100 mg orally on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles.	Drug: rituximab; Drug: cyclophosphamide; Drug: doxorubicin; Drug: VELCADE; Drug: prednisone
Experimental: VELCADE R-CP VELCADE will be administered as a 3- to 5-second intravenous bolus injection, rituximab 375 mg/m2 intravenous on Day 1, cyclophosphamide 1000 mg/m2 intravenous on Day 1, VELCADE 1.6 mg/m2 intravenous on Days 1 and 8, prednisone 100 mg orally on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles.	Drug: rituximab; Drug: cyclophosphamide; Drug: VELCADE; Drug: prednisone

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Complete Response (CR) [30 weeks]

   Disappearance of all evidence of disease assessed by computed tomography (CT) and PET (position-emission tomography) according to the revised International Working Group (IWG) Criteria.

Secondary Outcome Measures

1. Number of Participants With Overall Response (OR) [30 weeks]

   OR = Complete Response (CR) + Partial Response (PR)according to the revised International Working Group (IWG) Criteria. CR is the disappearance of all evidence of disease assessed by CT and PET. PR is the regression of measurable disease and no new sites assessed by CT and PET.

2. Percentage of Participants With Progression-free Survival (PFS) at 1 Year [Assessed at at the end of Cycle 2, at end of treatment visit, and every 12± 1 weeks for the first year (4 visits) until PD]

   PFS was defined as the time from the first dose to the date of progressive disease (PD)/relapse or death, whichever comes first. For a participant who had not progressed/relapsed or died, PFS was censored at the last response assessment that was stable disease (failure to attain complete response/partial response or PD or better).

3. Duration of Response [2 years]

   Time (in months) from the first documentation of a response (CR or partial response [PR]) to the date of first documentation of progressive disease or relapse from complete response. CR is defined as disappearance of all evidence of disease assessed by CT or PET; PR is defined as regression of measurable disease and no new sites assessed by CT or PET according to the revised International Working Group (IWG) Criteria.

4. Number of Patients Who Experienced at Least One Serious Adverse Event [From completion of informed consent through 30 days after the last dose of study drug]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female patient 18 years of age or older

• Pathological diagnosis of follicular lymphoma (any grade) or marginal zone lymphoma. Patients with transformed follicular lymphoma are eligible, provided there has previously been pathologic documentation of follicular lymphoma.

• Documented relapse or progression following prior antineoplastic therapy

• At least 1 measurable tumor mass that is greater than 1.5 cm in the long axis and greater than 1.0 cm in the short axis that has not been previously irradiated, or has grown since previous irradiation

• No clinically significant evidence of active central nervous system lymphoma

• Karnofsky performance status (KPS) ≥50 (equivalent to Eastern Cooperative Group Oncology Group [ECOG] status ≤2)

Exclusion Criteria:

• Diagnosed or treated for a malignancy other than Non-Hodgkin's Lymphoma (NHL) within 2 years of first dose, or who were previously diagnosed with a malignancy other than NHL and have any radiographic or biochemical marker evidence of malignancy. Patients with prostate cancer who were treated with definitive radiotherapy who have a serum prostate-specific antigen <1 ng/mL are not excluded. Patients are not excluded if they have had basal cell or squamous cell carcinoma of the skin that was completely resected, or any in situ malignancy that was adequately treated.

• Received any of the following treatments or procedures outside of the specified timeframes:

• Prior treatment with VELCADE

• Prior treatment with a cumulative dose of doxorubicin of more than 100 mg/m2, if assigned to Arm A (VELCADE-R-CAP)

• Antineoplastic (including unconjugated therapeutic antibodies and toxin immunoconjugates), experimental, or radiation therapy within 3 weeks before Day 1 of Cycle 1

• Nitrosoureas within 6 weeks before Day 1 of Cycle 1

• Radioimmunoconjugates within 10 weeks before Day 1 of Cycle 1

• Autologous stem cell transplant within 3 months before Day 1 of Cycle 1, or prior allogeneic stem cell transplant at any time

• Major surgery within 2 weeks before Day 1 of Cycle 1

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwest Alabama Center, PC	Muscle Shoals	Alabama	United States	35661
2	Providence Saint Joseph Medical Center	Burbank	California	United States	91505
3	Pacific Coast Hematology Oncology Medical Group	Fountain Valley	California	United States	92708
4	Loma Linda U Cancer Center	Loma Linda	California	United States	92354
5	Desert Hematology Medical Group, Inc.	Rancho Mirage	California	United States	92270
6	Cancer Center of Central Connecticut	Southington	Connecticut	United States	06498
7	Ocala Cancer Institute	Ocala	Florida	United States	34471
8	Northwest Georgia Oncology Centers, PC	Marietta	Georgia	United States	30060
9	Southern Illinois Hematology Oncology	Centralia	Illinois	United States	62801
10	Alexian Brothers Hospital Network	Elk Grove Village	Illinois	United States	60007
11	Clintell, Inc.	Skokie	Illinois	United States	60077
12	Cancer Care Center, Inc.	New Albany	Indiana	United States	47150
13	Siouxland Hematology Oncology Associates	Sioux City	Iowa	United States	51101
14	Hutchinson Clinic	Hutchinson	Kansas	United States	67502
15	Purchase Cancer Group	Paducah	Kentucky	United States	42001
16	Medical Oncology, LLC	Baton Rouge	Louisiana	United States	70809
17	St. Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106
18	Kalamazoo Hematology and Oncology	Kalamazoo	Michigan	United States	49048
19	Jackson Oncology Associates, PLLC	Jackson	Mississippi	United States	39202
20	St. Louis Cancer Care, LLP	Chesterfield	Missouri	United States	63017
21	Nebraska Hematology-Oncology, PC	Lincoln	Nebraska	United States	68506
22	Great Plains Regional Medical Center	North Platte	Nebraska	United States	69101
23	Southern Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
24	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
25	San Juan Oncology Associates	Farmington	New Mexico	United States	87401
26	NYU Clinical Cancer Center	New York	New York	United States	10016
27	Interlakes Foundation	Rochester	New York	United States	14623
28	New York Medical College	Valhalla	New York	United States	10595
29	Gabrail Cancer Center	Canton	Ohio	United States	44718
30	Oklahoma Oncology and Hematology, PC	Oklahoma City	Oklahoma	United States	73112
31	Oklahoma Oncology and Hematology, PC	Tulsa	Oklahoma	United States	74136
32	Temple University	Philadelphia	Pennsylvania	United States	19140
33	Allegheny-Singer Research Institute	Pittsburgh	Pennsylvania	United States	15212
34	Western Pennsylvania Cancer Institute	Pittsburgh	Pennsylvania	United States	15224
35	Landmark Medical Center	Woonsocket	Rhode Island	United States	02895
36	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
37	University of Tennessee Medical Center	Knoxville	Tennessee	United States	37920
38	HOPE Oncology	Richardson	Texas	United States	75080
39	Northern Utah Associates	Ogden	Utah	United States	84403
40	Marshall University	Huntington	West Virginia	United States	25701
41	West Virginia University Health Science Center	Morgantown	West Virginia	United States	26505
42	Marshfield Clinic	Marshfield	Wisconsin	United States	54449
43	Auxilio Cancer Center	Hato Rey		Puerto Rico	00919

Sponsors and Collaborators

• Millennium Pharmaceuticals, Inc.

Investigators

• Study Director: Medical Monitor, Millennium Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Millennium Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT00715208
• Other Study ID Numbers: C05012
• First Posted: Jul 15, 2008
• Last Update Posted: Apr 29, 2013
• Last Verified: Apr 1, 2013

• Additional relevant MeSH terms: Lymphoma; Lymphoma, Follicular; Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Bortezomib

Study Results

Participant Flow

Arm/Group Title	VELCADE R-CAP	VELCADE R-CP
Arm/Group Description	VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin	VELCADE, rituximab, cyclophosphamide, and prednisone
Period Title: Overall Study
STARTED	7	48
COMPLETED	6	39
NOT COMPLETED	1	9

Baseline Characteristics

Arm/Group Title	VELCADE R-CAP	VELCADE R-CP	Total
Arm/Group Description	VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin	VELCADE, rituximab, cyclophosphamide, and prednisone	Total of all reporting groups
Overall Participants	7	48	55
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	7 100%	27 56.3%	34 61.8%
>=65 years	0 0%	21 43.8%	21 38.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.9 (8.30)	62.3 (11.39)	62.3 (10.98)
Sex: Female, Male (Count of Participants)
Female	5 71.4%	24 50%	29 52.7%
Male	2 28.6%	24 50%	26 47.3%
Region of Enrollment (participants) [Number]
United States	7 100%	48 100%	55 100%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Complete Response (CR)
Description	Disappearance of all evidence of disease assessed by computed tomography (CT) and PET (position-emission tomography) according to the revised International Working Group (IWG) Criteria.
Time Frame	30 weeks

Outcome Measure Data

Analysis Population Description

Response evaluable: measurable disease at baseline, completed first scheduled response evaluation, or do not complete first scheduled response evaluation due to progressive disease (PD) or death.

Arm/Group Title	VELCADE R-CAP	VELCADE R-CP
Arm/Group Description	VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin	VELCADE, rituximab, cyclophosphamide, and prednisone
Measure Participants	6	48
Number [participants]	1 14.3%	13 27.1%

2. Secondary Outcome

Title	Number of Participants With Overall Response (OR)
Description	OR = Complete Response (CR) + Partial Response (PR)according to the revised International Working Group (IWG) Criteria. CR is the disappearance of all evidence of disease assessed by CT and PET. PR is the regression of measurable disease and no new sites assessed by CT and PET.
Time Frame	30 weeks

Outcome Measure Data

Analysis Population Description

Response evaluable: measurable disease at baseline, completed first scheduled response evaluation, or do not complete first scheduled response evaluation due to PD or death.

Arm/Group Title	VELCADE R-CAP	VELCADE R-CP
Arm/Group Description	VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin	VELCADE, rituximab, cyclophosphamide, and prednisone
Measure Participants	6	48
Number [participants]	6 85.7%	37 77.1%

3. Secondary Outcome

Title	Percentage of Participants With Progression-free Survival (PFS) at 1 Year
Description	PFS was defined as the time from the first dose to the date of progressive disease (PD)/relapse or death, whichever comes first. For a participant who had not progressed/relapsed or died, PFS was censored at the last response assessment that was stable disease (failure to attain complete response/partial response or PD or better).
Time Frame	Assessed at at the end of Cycle 2, at end of treatment visit, and every 12± 1 weeks for the first year (4 visits) until PD

Outcome Measure Data

Analysis Population Description

Safety population: Treated

Arm/Group Title	VELCADE R-CAP	VELCADE R-CP
Arm/Group Description	VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin	VELCADE, rituximab, cyclophosphamide, and prednisone
Measure Participants	7	48
Number [percentage of participants]	67 957.1%	63 131.3%

4. Secondary Outcome

Title	Duration of Response
Description	Time (in months) from the first documentation of a response (CR or partial response [PR]) to the date of first documentation of progressive disease or relapse from complete response. CR is defined as disappearance of all evidence of disease assessed by CT or PET; PR is defined as regression of measurable disease and no new sites assessed by CT or PET according to the revised International Working Group (IWG) Criteria.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Responders: CR + PR (Not done for VELCADE R-CAP, only 5 responders)

Arm/Group Title	VELCADE R-CAP	VELCADE R-CP
Arm/Group Description	VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin	VELCADE, rituximab, cyclophosphamide, and prednisone
Measure Participants	0	37
Median (95% Confidence Interval) [Months]	21.9

5. Secondary Outcome

Title	Number of Patients Who Experienced at Least One Serious Adverse Event
Time Frame	From completion of informed consent through 30 days after the last dose of study drug

Outcome Measure Data

Analysis Population Description

Safety Population: Treated patients

Arm/Group Title	VELCADE R-CAP	VELCADE R-CP
Arm/Group Description	VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin	VELCADE, rituximab, cyclophosphamide, and prednisone
Measure Participants	7	48
Number [participants]	2 28.6%	12 25%

Adverse Events

Arm/Group Title	VELCADE R-CAP		VELCADE R-CP
Arm/Group Description	VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin		VELCADE, rituximab, cyclophosphamide, and prednisone
All Cause Mortality
	VELCADE R-CAP		VELCADE R-CP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	VELCADE R-CAP		VELCADE R-CP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/7 (28.6%)		12/48 (25%)
Blood and lymphatic system disorders
Febrile neutropenia	1/7 (14.3%)		1/48 (2.1%)
Neutropenia	0/7 (0%)		1/48 (2.1%)
Lymphadenopathy	0/7 (0%)		2/48 (4.2%)
Leukopenia NOS	1/7 (14.3%)		0/48 (0%)
Cardiac disorders
Cardiac failure congestive	0/7 (0%)		1/48 (2.1%)
Myocardial infarction	0/7 (0%)		1/48 (2.1%)
Atrial fibrillation	0/7 (0%)		1/48 (2.1%)
Eye disorders
Vision blurred	0/7 (0%)		1/48 (2.1%)
Gastrointestinal disorders
Ascites	0/7 (0%)		1/48 (2.1%)
Abdominal pain NOS	0/7 (0%)		1/48 (2.1%)
General disorders
Pyrexia	1/7 (14.3%)		3/48 (6.3%)
Fatigue	0/7 (0%)		1/48 (2.1%)
Weakness	0/7 (0%)		1/48 (2.1%)
Infections and infestations
Bronchitis NOS	0/7 (0%)		1/48 (2.1%)
Bronchitis acute NOS	0/7 (0%)		1/48 (2.1%)
Pneumonia NOS	0/7 (0%)		1/48 (2.1%)
Bacteraemia	0/7 (0%)		1/48 (2.1%)
Neutropenic sepsis	1/7 (14.3%)		0/48 (0%)
Oropharyngeal candidiasis	1/7 (14.3%)		0/48 (0%)
Respiratory tract infection NOS	0/7 (0%)		1/48 (2.1%)
Cellulitis	0/7 (0%)		1/48 (2.1%)
Viral infection NOS	0/7 (0%)		1/48 (2.1%)
Investigations
Blood culture positive	0/7 (0%)		2/48 (4.2%)
Electrocardiogram T wave abnormal	0/7 (0%)		1/48 (2.1%)
Musculoskeletal and connective tissue disorders
Back pain	0/7 (0%)		1/48 (2.1%)
Pain in limb	0/7 (0%)		1/48 (2.1%)
Nervous system disorders
Syncope	0/7 (0%)		1/48 (2.1%)
Headache NOS	0/7 (0%)		1/48 (2.1%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea NOS	0/7 (0%)		1/48 (2.1%)
Chronic obstructive airways disease exacerbated	0/7 (0%)		1/48 (2.1%)
Lung infiltration NOS	0/7 (0%)		1/48 (2.1%)
Pleural effusion	0/7 (0%)		1/48 (2.1%)
Respiratory failure (excl neonatal)	0/7 (0%)		1/48 (2.1%)
Vascular disorders
Hypertension aggravated	0/7 (0%)		1/48 (2.1%)
Other (Not Including Serious) Adverse Events
	VELCADE R-CAP		VELCADE R-CP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/7 (100%)		47/48 (97.9%)
Blood and lymphatic system disorders
Anaemia	3/7 (42.9%)		8/48 (16.7%)
Thrombocytopenia	3/7 (42.9%)		6/48 (12.5%)
Lymphopenia	2/7 (28.6%)		6/48 (12.5%)
Cardiac disorders
Tachycardia NOS	1/7 (14.3%)		1/48 (2.1%)
Sinus Tachycardia	1/7 (14.3%)		2/48 (4.2%)
Ventricular hypokinesia	1/7 (14.3%)		0/48 (0%)
Ear and labyrinth disorders
Tinnitus	1/7 (14.3%)		1/48 (2.1%)
Eye disorders
Lacrimation increased	0/7 (0%)		4/48 (8.3%)
Eye irritation	0/7 (0%)		4/48 (8.3%)
Gastrointestinal disorders
Diarrhoea	2/7 (28.6%)		24/48 (50%)
Nausea	3/7 (42.9%)		21/48 (43.8%)
Vomiting NOS	0/7 (0%)		12/48 (25%)
Constipation	3/7 (42.9%)		10/48 (20.8%)
Stomatitis	3/7 (42.9%)		2/48 (4.2%)
Pharyngolaryngeal pain	0/7 (0%)		3/48 (6.3%)
General disorders
Rigors	4/7 (57.1%)		6/48 (12.5%)
Oedema lower limb	2/7 (28.6%)		5/48 (10.4%)
Fatigue aggravated	1/7 (14.3%)		5/48 (10.4%)
Infusion associated symptoms	0/7 (0%)		3/48 (6.3%)
Fall	2/7 (28.6%)		0/48 (0%)
Chest pain	0/7 (0%)		3/48 (6.3%)
Hepatobiliary disorders
Hypoproteinaemia	1/7 (14.3%)		1/48 (2.1%)
Immune system disorders
Hypersensitivity NOS	1/7 (14.3%)		0/48 (0%)
Infections and infestations
Upper respiratory tract infection NOS	0/7 (0%)		8/48 (16.7%)
Herpes zoster	1/7 (14.3%)		3/48 (6.3%)
Urinary tract infection NOS	1/7 (14.3%)		3/48 (6.3%)
Nasopharyngitis	1/7 (14.3%)		1/48 (2.1%)
Investigations
White blood cell count decreased	1/7 (14.3%)		4/48 (8.3%)
Lymphocyte count decreased	0/7 (0%)		4/48 (8.3%)
Neutrophil count decreased	0/7 (0%)		4/48 (8.3%)
Haemoglobin decreased	0/7 (0%)		6/48 (12.5%)
Blood uric acid increased	0/7 (0%)		4/48 (8.3%)
Platelet count decreased	0/7 (0%)		4/48 (8.3%)
Blood glucose increased	0/7 (0%)		3/48 (6.3%)
Blood urea increased	1/7 (14.3%)		1/48 (2.1%)
Blood creatinine increased	1/7 (14.3%)		0/48 (0%)
Metabolism and nutrition disorders
Anorexia	2/7 (28.6%)		6/48 (12.5%)
Dehydration	3/7 (42.9%)		3/48 (6.3%)
Hypocalcaemia	2/7 (28.6%)		2/48 (4.2%)
Hyperglycaemia NOS	1/7 (14.3%)		3/48 (6.3%)
Hypokalaemia	1/7 (14.3%)		1/48 (2.1%)
Hyponatraemia	1/7 (14.3%)		2/48 (4.2%)
Hyperuricaemia	1/7 (14.3%)		0/48 (0%)
Musculoskeletal and connective tissue disorders
Musculoskeletal pain	0/7 (0%)		6/48 (12.5%)
Arthralgia	1/7 (14.3%)		5/48 (10.4%)
Bone pain	0/7 (0%)		3/48 (6.3%)
Myalgia	1/7 (14.3%)		2/48 (4.2%)
Muscle cramps	2/7 (28.6%)		1/48 (2.1%)
Peripheral swelling	0/7 (0%)		3/48 (6.3%)
Nervous system disorders
Peripheral neuropathy NOS	2/7 (28.6%)		10/48 (20.8%)
Peripheral sensory neuropathy	0/7 (0%)		3/48 (6.3%)
Peripheral neuropathy aggravated	1/7 (14.3%)		0/48 (0%)
Dizziness (excl vertigo)	2/7 (28.6%)		7/48 (14.6%)
Dysgeusia	4/7 (57.1%)		1/48 (2.1%)
Paraesthesia	1/7 (14.3%)		0/48 (0%)
Restless leg syndrome	1/7 (14.3%)		0/48 (0%)
Psychiatric disorders
Insomnia	2/7 (28.6%)		7/48 (14.6%)
Confusion	1/7 (14.3%)		0/48 (0%)
Renal and urinary disorders
Renal failure acute	1/7 (14.3%)		1/48 (2.1%)
Reproductive system and breast disorders
Breast discomfort	1/7 (14.3%)		0/48 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	1/7 (14.3%)		8/48 (16.7%)
Rhinitis NOS	1/7 (14.3%)		0/48 (0%)
Epistaxis	2/7 (28.6%)		0/48 (0%)
Pulmonary congestion	0/7 (0%)		3/48 (6.3%)
Skin and subcutaneous tissue disorders
Alopecia	4/7 (57.1%)		8/48 (16.7%)
Night sweats	2/7 (28.6%)		2/48 (4.2%)
Dry skin	0/7 (0%)		3/48 (6.3%)
Skin lesion NOS	1/7 (14.3%)		0/48 (0%)
Skin hypopigmentation	1/7 (14.3%)		0/48 (0%)
Nail disorder	1/7 (14.3%)		0/48 (0%)
Palmar-plantar erythrodysaesthesia syndrome	1/7 (14.3%)		0/48 (0%)
Vascular disorders
Hypotension NOS	2/7 (28.6%)		2/48 (4.2%)
Flushing	0/7 (0%)		3/48 (6.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.