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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01253681




Registration number
NCT01253681
Ethics application status
Date submitted
21/10/2010
Date registered
3/12/2010
Date last updated
14/10/2015

Titles & IDs
Public title
Study of AMG 386 in Combination With Paclitaxel and Carboplatin in Subjects With Ovarian Cancer
Scientific title
A Phase 1b Open-Label, Multi-Center Study of AMG 386 in Combination With Paclitaxel and Carboplatin in Subjects With High-Risk Stage I and Stages II-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
Secondary ID [1] 0 0
20090155
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma 0 0
Fallopian Tube Cancer 0 0
Ovarian Cancer 0 0
Primary Peritoneal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 386, paclitaxel and carboplatin

Experimental: AMG 386, paclitaxel and carboplatin - 15 mg/Kg AMG 386 IV (intravenous) weekly plus paclitaxel and carboplatin IV Q3W for 18 weeks, followed by 15mg/Kg AMG 386 IV (intravenous) weekly alone for an additional 18 months.


Treatment: Drugs: AMG 386, paclitaxel and carboplatin
15 mg/Kg AMG 386 IV (intravenous) weekly plus paclitaxel and carboplatin IV Q3W for 18 weeks, followed by 15mg/Kg AMG 386 IV (intravenous) weekly alone for an additional 18 months.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate whether AMG 386 in combination with paclitaxel and carboplatin is safe and well tolerated in the first-line treatment of high-risk stage I and stages II-IV epithelial ovarian, primary peritoneal and fallopian tube cancers.
Timepoint [1] 0 0
18 weeks of combination therapy
Secondary outcome [1] 0 0
To evaluate the pharmacokinetics (Cmax, AUC and Cmin) of AMG 386 in combination with carboplatin and paclitaxel
Timepoint [1] 0 0
Week 1 until Week 7
Secondary outcome [2] 0 0
To estimate the incidence of anti-AMG 386 antibody formation
Timepoint [2] 0 0
Week 1 until maximum of 1 year following first dose
Secondary outcome [3] 0 0
To evaluate the objective response rate (ORR) among subjects receiving AMG 386 in combination with carboplatin and paclitaxel
Timepoint [3] 0 0
From date of first dose until the subject reaches End of Study. This will continue until 36 months after the last subject has been enrolled.
Secondary outcome [4] 0 0
To evaluate the duration of response (DOR) among subjects receiving AMG 386 in combination with carboplatin and paclitaxel
Timepoint [4] 0 0
From date of first dose until the subject reaches End of Study. This will continue until 36 months after the last subject has been enrolled.
Secondary outcome [5] 0 0
To evaluate progression-free survival (PFS) among subjects receiving AMG 386 in combination with carboplatin and paclitaxel
Timepoint [5] 0 0
From date of first dose until the subject reaches End of Study. This will continue until 36 months after the last subject has been enrolled.
Secondary outcome [6] 0 0
To evaluate the number of participants with adverse events and clinical laboratory abnormalities
Timepoint [6] 0 0
96 weeks
Secondary outcome [7] 0 0
To evaluate the effect of AMG 386 on the pharmacokinetics (Cmax, AUC and Cmin) of carboplatin and paclitaxel
Timepoint [7] 0 0
Week 1 until Week 7

Eligibility
Key inclusion criteria
* Female subjects more than 18 years of age with newly diagnosed high-risk FIGO Stage I (grade 3, or aneuploid grade 1 or 2) or Stages II-IV epithelial ovarian, primary peritoneal and fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin x 6 cycles. Subjects with pseudomyxoma, mesothelioma, adenocarcinoma of unknown primary tumor, sarcoma, or neuroendocrine histology are excluded.
* Subjects with high-risk stage I, stage II, or stage IIIA-B must have had prior primary debulking surgery that occurred no less than 4 weeks, and no more than 12 weeks, prior to enrollment. Subjects must have recovered fully from surgery in the opinion of the investigator
* Subjects with Stage IIIC or IV disease who have not had primary debulking surgery must have planned interval debulking surgery following 3 cycles of AMG 386, paclitaxel and carboplatin
* Female 18 years of age or older at the time the written informed consent is obtained
* Subjects of child-bearing potential who have not undergone a bilateral salpingo-oophorectomy and are sexually active must consent to use an accepted and effective non-hormonal method of contraception (i.e, double barrier method (eg, condom plus diaphragm) from signing the informed consent through 6 months after last dose of study drug
* GOG Performance Status of 0 or 1
* Life expectancy = 3 months (per investigator opinion)
* Subject plans to begin protocol-directed therapy within 7 days from enrollment
* Adequate organ and hematological function as evidenced by the following laboratory studies prior to enrollment:

Hematological function, as follows:

* Hemoglobin = 9 g/dL
* Absolute neutrophil count (ANC) = 1.5 x 10x9/L
* Platelet count = 100 x 10x9/L and = 850 x 10x9/L
* PTT or aPTT = 1.5 x ULN per institutional laboratory range and INR = 1.5

Renal function, as follows:

* Urinary protein quantitative value of = 30 mg/dL in urinalysis or = 1+ on dipstick, unless quantitative protein is < 1000 mg in a 24 hour urine sample
* Creatinine clearance > 40 mL/min per 24-hr urine collection or calculated according to the Cockcroft-Gault formula

Hepatic function, as follows:

* AST and ALT = 2.5 x ULN per institutional laboratory range (or = 5 x ULN if liver metastases are present)
* Total bilirubin = 1.5x institutions' ULN Nutritional
* Albumin = 2.8 g/dL
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior use of anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancers
* Previous abdominal and/or pelvic external beam radiotherapy
* Subjects believed to be a higher than average risk of bowel perforation. This includes current symptoms of partial or complete bowel obstruction, recent (within 6 months) history of fistula or bowel perforation, subjects requiring total parenteral nutrition and continuous hydration
* History of arterial or venous thromboembolism within 12 months prior to enrollment
* History of clinically significant bleeding within 6 months prior to enrollment
* History of central nervous system metastasis
* Known active or ongoing infection (except uncomplicated urinary tract infection) within 14 days prior to enrollment
* Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor
* Current or within 30 days prior to enrollment treatment with immune modulators such as systemic cyclosporine or tacrolimus
* Prior myeloablative high-dose chemotherapy with allogeneic or autologous stem cell (or bone marrow) transplant
* Clinically significant cardiac disease within 12 months prior to enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication or placement of percutaneous transluminal coronary angioplasty/stent
* Uncontrolled hypertension as defined as diastolic blood pressure > 90 mmHg OR systolic blood pressure > 140 mmHg. The use of anti-hypertensive medications to control hypertension is permitted
* Subjects with a history of prior malignancy, except:

Malignancy treated with curative intent and with no known active disease present for = 3 years prior to enrollment and felt to be at low risk for recurrence by treating physician, Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease Adequately treated cervical carcinoma in situ without evidence of disease

* Major surgery within 28 days prior to enrollment or still recovering from prior surgery
* Minor surgical procedures, including placement of tunneled central venous access device, within 3 days prior to enrollment
* History of allergic reactions to bacterially-produced proteins
* Hypersensitivity to paclitaxel or drugs using the vehicle cremophor
* Pregnant (ie, positive beta-human chorionic gonadotropin test) or is breast feeding or planning to become pregnant within 6 months after the end of treatment
* Subject has known positive test(s) for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic active hepatitis B infection
* Any condition which in the investigator's opinion makes the subject unsuitable for study participation
* Any uncontrolled concurrent illness or history of any medical condition that may interfere with the interpretation of the study results
* Non-healing wound, ulcer (including gastrointestinal) or fracture
* Subject has previously been enrolled onto this study
* Subject will not be available for follow-up assessment
* Subject has known sensitivity to any of the products to be administered during dosing
* Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2015
Sample size
Target
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Research Site - Footscray
Recruitment hospital [2] 0 0
Research Site - Malvern
Recruitment hospital [3] 0 0
Research Site - Parkville
Recruitment postcode(s) [1] 0 0
3011 - Footscray
Recruitment postcode(s) [2] 0 0
3144 - Malvern
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Belgium
State/province [2] 0 0
Bruxelles
Country [3] 0 0
Belgium
State/province [3] 0 0
Leuven
Country [4] 0 0
Spain
State/province [4] 0 0
Cataluña
Country [5] 0 0
Spain
State/province [5] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01253681