Trial Outcomes & Findings for Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors (NCT NCT00788125)
NCT ID: NCT00788125
Last Updated: 2023-07-14
Results Overview
This field captured the maximum dose of dasatinib administered.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
7 participants
Primary outcome timeframe
28 days after start of course 1
Results posted on
2023-07-14
Participant Flow
Phase I study participants were recruited based on physician referral at City of Hope Medical Center, between September 04, 2008 and February 04, 2010. Seven patients met the inclusion criteria and were enrolled on the study.
Phase I of this study involved City of Hope patients, only. This protocol did not progress beyond Period 1: 35 mg/m\^2/dose BID to other dose levels within Phase I. This protocol did not progress to Phase II, which would have involved other institutions. Sponsor withdrew support.
Participant milestones
| Measure |
Period 1: 35 mg/m^2 Dasatinib BID PO
35 mg/m\^2/dose BID PO Dasatinib x 17 days
Ifosfamide, Carboplatin, Etoposide
microarray analysis
western blotting
immunohistochemistry staining method
laboratory biomarker analysis
therapeutic conventional surgery
radiation therapy
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Period 1: 35 mg/m^2 Dasatinib BID PO
35 mg/m\^2/dose BID PO Dasatinib x 17 days
Ifosfamide, Carboplatin, Etoposide
microarray analysis
western blotting
immunohistochemistry staining method
laboratory biomarker analysis
therapeutic conventional surgery
radiation therapy
|
|---|---|
|
Overall Study
Death
|
6
|
Baseline Characteristics
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
Baseline characteristics by cohort
| Measure |
Period 1: 35 mg/m^2 Dasatinib BID PO
n=7 Participants
35mg/m\^2/dose BID PO Dasatinib x 17 days
Ifosfamide, Carboplatin, Etoposide
microarray analysis
western blotting
immunohistochemistry staining method
laboratory biomarker analysis
therapeutic conventional surgery
radiation therapy
|
|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
14.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days after start of course 1Population: Level -1: 25 mg/m\^2/dose BID PO Dasatinib x 17 days. Period 1: 35 mg/m\^2/dose BID PO Dasatinib x 17 days. Period 2: 50 mg/m\^2/dose BID PO Dasatinib x 17 days. Period 3: 65 mg/m\^2/dose BID PO Dasatinib x 17 days. Period 4: 85 mg/m\^2/dose BID PO Dasatinib x 17 days. Period 5 (Dasatinib alone phase only): 110 mg/m\^2/dose BID PO. Sponsor withdrew support before a second level could be attempted.
This field captured the maximum dose of dasatinib administered.
Outcome measures
| Measure |
Period 1: 35 mg/m^2/Dose BID PO Dasatinib x 17 Days
n=7 Participants
35 mg/m\^2/dose BID PO Dasatinib x 17 days
Ifosfamide, Carboplatin, Etoposide
therapeutic conventional surgery
radiation therapy
|
|---|---|
|
Maximum Administered Dose of Dasatinib (Phase I)
|
35 mg/m2 dose BID
|
Adverse Events
Period 1: 35 mg/m^2 Dasatinib BID PO
Serious events: 6 serious events
Other events: 7 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Period 1: 35 mg/m^2 Dasatinib BID PO
n=7 participants at risk
35mg/m\^2/dose BID PO Dasatinib x 17 days
Iphosfamide, Carboplatin, Etoposide
microarray analysis
western blotting
immunohistochemistry staining method
laboratory biomarker analysis
therapeutic conventional surgery
radiation therapy
|
|---|---|
|
Infections and infestations
Infection -- Brain (encephalitis, infections)
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death not associated with CTCAE term -- Death NOS
|
57.1%
4/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death not associated with CTCAE term -- Disease progression, NOS
|
28.6%
2/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
Other adverse events
| Measure |
Period 1: 35 mg/m^2 Dasatinib BID PO
n=7 participants at risk
35mg/m\^2/dose BID PO Dasatinib x 17 days
Iphosfamide, Carboplatin, Etoposide
microarray analysis
western blotting
immunohistochemistry staining method
laboratory biomarker analysis
therapeutic conventional surgery
radiation therapy
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersnsitivity (including drug fever)
|
28.6%
2/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
85.7%
6/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
85.7%
6/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
85.7%
6/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Blood and lymphatic system disorders
Platelets
|
85.7%
6/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Cardiac disorders
Palpitations
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
71.4%
5/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Cardiac disorders
Vasovagal episode
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Cardiac disorders
Hypotension
|
57.1%
4/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Vascular disorders
INR (International Normalized Ratio of prothrombin time)
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Vascular disorders
PTT (Partial Thromboplastin Time)
|
28.6%
2/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
71.4%
5/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
General disorders
Fever (absent of neutropenia, ANC<1.0E9/L)
|
57.1%
4/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
General disorders
Insomnia
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
General disorders
Rigors/chills
|
57.1%
4/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
General disorders
Sweating (diaphoresis)
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
General disorders
Weight gain
|
28.6%
2/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
General disorders
Weight loss
|
28.6%
2/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Skin and subcutaneous tissue disorders
Bruising (in abscence of Grade 3 or 4 thrombocytopenia)
|
42.9%
3/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Skin and subcutaneous tissue disorders
Blue Skin
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Skin and subcutaneous tissue disorders
Contact Dermatitis
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Skin and subcutaneous tissue disorders
Discoloration
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Skin and subcutaneous tissue disorders
Pale
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Skin and subcutaneous tissue disorders
Blue
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
57.1%
4/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
71.4%
5/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
42.9%
3/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
71.4%
5/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
57.1%
4/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Endocrine disorders
Cushingoid appearance (e.g. moon face, buffalo hump, centripetal obesity, cutaneous striae)
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Gastrointestinal disorders
Anorexia
|
28.6%
2/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Gastrointestinal disorders
Constipation
|
42.9%
3/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Gastrointestinal disorders
Diarrhea
|
71.4%
5/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
28.6%
2/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
28.6%
2/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Gastrointestinal disorders
Esophagitis
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Gastrointestinal disorders
Flatulence
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
42.9%
3/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
57.1%
4/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
28.6%
2/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Gastrointestinal disorders
Nausea
|
85.7%
6/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Gastrointestinal disorders
Salivary gland changes/saliva
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Gastrointestinal disorders
Vomiting
|
85.7%
6/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Vascular disorders
Hematoma
|
42.9%
3/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Vascular disorders
Hemorrhage, GI
|
28.6%
2/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Vascular disorders
Hemorrhage, GU
|
28.6%
2/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Vascular disorders
Hemorrhage, pulmonary/upper respiratory
|
42.9%
3/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Vascular disorders
Hemorrhage/Bleeding -- Other, Conjunctival
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Vascular disorders
Hemorrhage/Bleeding -- Other, Scleral
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Infections and infestations
Febrile neutropenia ANC<1E9/L (fever of unknown origin without documented infection)
|
28.6%
2/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Infections and infestations
Infection with Gr 3 or 4 neutrophils (ANC<1E9/L)
|
71.4%
5/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophil
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
28.6%
2/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Blood and lymphatic system disorders
Edema: limb
|
42.9%
3/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Blood and lymphatic system disorders
Edema: trunk/genital
|
42.9%
3/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
71.4%
5/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
71.4%
5/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
85.7%
6/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
42.9%
3/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Metabolism and nutrition disorders
Alkalosis metabolic or respiratory)
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
85.7%
6/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
71.4%
5/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Metabolism and nutrition disorders
Creatinine
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
57.1%
4/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
28.6%
2/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
71.4%
5/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory -- Other: Hematochromatomatosis
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
85.7%
6/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
85.7%
6/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Metabolism and nutrition disorders
Proteinuria
|
42.9%
3/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
85.7%
6/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
71.4%
5/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not due to neuropathy, Extremity Lower
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not due to neuropathy, Extremity Upper
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular/skeletal hypoplasia
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue, Other: Atrophy
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue, Other: Avulsion
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue, Other: Osteopenia
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Nervous system disorders
Ataxia (incoordination)
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Nervous system disorders
Confusion
|
28.6%
2/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Nervous system disorders
Dizziness
|
42.9%
3/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Nervous system disorders
Memory Impairment
|
28.6%
2/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Psychiatric disorders
Mood alteration
|
71.4%
5/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Psychiatric disorders
Mood alteration, depression
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Psychiatric disorders
Personality/behavioral
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Psychiatric disorders
Psychosis (hallucinations/delusions)
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Nervous system disorders
Somnolescence/depressed level of consciousness
|
42.9%
3/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Nervous system disorders
Syncope (fainting)
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Nervous system disorders
Tremor
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Eye disorders
Dry eye syndrome
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Eye disorders
Ocular/visual, other: Conjunctivitis
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
General disorders
Pain
|
85.7%
6/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
General disorders
Pain, other: Cathetar related
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
42.9%
3/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
57.1%
4/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
57.1%
4/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
28.6%
2/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory, Other: Phrenic Nerve Cut
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Renal and urinary disorders
Bladder spasms
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Renal and urinary disorders
Incontinence, urinary
|
28.6%
2/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Renal and urinary disorders
Urine color change
|
14.3%
1/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
|
Vascular disorders
Petechiae/purpura (hemorrhage/bleeding into the skin or mucosa)
|
42.9%
3/7 • Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60