clinical study for pediatric patients with solid tumors that have come back after disappearing or that don’t respond to any treatment, designed to find the safest and most tolerable dose of nab ®-paclitaxel and to asses the preliminary efficacy of the treatment.
- Conditions
- recurrent or refractory solid tumorMedDRA version: 16.0Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-000144-26-FR
- Lead Sponsor
- Abraxis BioScience, LLC, a wholly-owned subsidiary of Celgene Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 107
1. Patient is male or female, meeting the following age requirements at the time the
informed consent document (and assent form, if applicable) is signed.
a. Phase 1: patient is = 6 months to < 18 years of age
b. Phase 2: patient is = 6 months to = 21 years of age
2. Patient has a confirmed solid tumor diagnosis according to the following:
a. Phase 1: patient has a recurrent or refractory solid tumor that has progressed or
did not respond to standard therapy, or for which no standard anticancer therapy exists
b. Phase 2: patient has one of the following tumor types and has failed first or
second-line treatment or has evidence of refractory disease
i. Group 1: neuroblastoma
ii. Group 2: rhabdomyosarcoma
iii. Group 3: mixed solid tumors, including nonrhabdomyosarcoma soft tissue
sarcoma, melanoma, or other tumor types identified during the Phase 1 portion or in preclinical studies
3. The patient has a Lansky/ Karnofsky performance status score of = 70%
4. The patient has adequate serum chemistry levels, evidenced by the following laboratory values
a. AST (SGOT), ALT (SGPT) = 2.5 × upper limit of normal range (ULN)
b. Total bilirubin = 1.5 × ULN
c. Creatinine = 1.5 × ULN
5. The patient has adequate bone marrow function, evidenced by the following:
a. Absolute neutrophil count = 1.0 × 10^9 cells/L
b. Platelets = 80 × 10^9 cells/L (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to laboratory sample)
c. Hemoglobin = 8 g/dL (transfusion is permitted to fulfill this criterion)
6. The patient (when applicable) or patient’s parent(s) or legal guardian(s) understand(s)
and voluntarily signed an informed consent document prior to any study-related
assessments/procedures being conducted. Where locally applicable, the patient also
understands and voluntarily provides his/her assent prior to any study-related
assessments/procedures being conducted.
7. Male patients of childbearing potential must use a condom during sexual intercourse and shall not father a child during the study and for 6 months after the last dose of study medication.
8. Female patients of childbearing potential [defined as all female patients = 12 years old or who have reached menarche, whichever occurs first] must have both of the following:
a. Agree to the use of two physician-approved contraceptive methods simultaneously or practice complete abstinence while on study medication and for
3 months following the last dose of study medication
i. True abstinence: When this is in line with the preferred and usual lifestyle
of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.
ii. Acceptable contraceptive methods include: oral, injectable, or implantable
hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) including at least one barrier method.
b. Have negative serum pregnancy test result at screening confirmed by negative
urine pregnancy dipstick within 72 hours prior to first dose of IP (if serum test
occurred > 72 hours from first dose); pregnancy test with sensitivity of at least 25
mIU/mL
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly
1. The patient has a primary brain tumor(s) or brain metastasis (unless metastasis is treated and stable for > 28 days). In patients who are symptomatic, a brain scan is required to exclude metastasis.
2. The patient has received therapeutic dose chemotherapy or radiotherapy = 21 days prior to start of IP.
3. The patient has received maintenance dose chemotherapy (e.g., low dose
cyclophosphamide) = 7 days from the first dose of IP.
4. The patient has received any investigational therapy = 28 days prior to start of IP.
Investigational therapy is defined as any medicinal product that is not approved in the
country of treatment for any indication, adult or pediatric
5. The patient has received any biological therapy = 7 days prior to the start of IP, or
monoclonal antibody = 3 half-lives or 28 days, whichever is shorter, prior to the first dose of IP.
6. The patient has had major surgery or significant trauma = 14 days prior to start of IP.
7. The patient has not recovered from the acute toxic effects of prior chemotherapy,
radiation, or major surgery/significant trauma.
8. The patient has had minor surgery = 7 days from the start of study treatment (excluding the placement of central/
peripheral lines, skin biopsy).
9. The patient has a known history of stroke, myocardial infarction, peripheral vascular disease, or recent (within 3 months) uncontrolled deep venous thrombosis.
10. The patient has a known history or current diagnosis of HIV infection, regardless of treatment status.
11. The patient has an uncontrolled intercurrent illness including but not limited to ongoing or active infection requiring antibiotic, antifungal, or antiviral therapy, symptomatic heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
12. The patient has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study.
13. The patient has any condition, including the presence of laboratory abnormalities, that places him/her at unacceptable risk if he/she were to participate in the study.
14. The patient has any condition that confounds the ability to interpret data from the study.
15. The patient or parent(s)/guardian(s) is/are unable to comply with the study visit schedule and other protocol requirements, in the opinion of the investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method