Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00770536




Registration number
NCT00770536
Ethics application status
Date submitted
9/10/2008
Date registered
10/10/2008
Date last updated
29/09/2015

Titles & IDs
Public title
AMG386 Comb w. Either Pegylated Liposomal Doxorubicin or Topotecan Subjects w. Advanced Recurrent Epithelial Ovarian CR
Scientific title
A Phase 1b Study of AMG 386 in Combination With Either Pegylated Liposomal Doxorubicin or Topotecan in Subjects With Advanced Recurrent Epithelial Ovarian Cancer
Secondary ID [1] 0 0
20070182
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Carcinoma 0 0
Fallopian Tube Cancer 0 0
Gynecological Malignancies 0 0
Metastases 0 0
Oncology 0 0
Ovarian Cancer 0 0
Solid Tumors 0 0
Tumors 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 - A1: AMG 386 10 mg/kg + Liposomal doxorubicin
Treatment: Drugs - A3: AMG 386 15mg/kg + Liposomal doxorubicin
Treatment: Drugs - B1: AMG 386 10 mg/kg + Topotecan
Treatment: Drugs - B3: AMG 386 15mg/kg + Topotecan

Experimental: Part 1 - In part 1, six subjects will be assigned to each cohort A or B. This is a dose escalation/de escalation study with a 6 + 3 design based on the incidence of DLTs (dose limiting toxicities) during the first 4 weeks of combined therapy \[(cohort A: AMG 386 and pegylated liposomal doxorubicin) or (cohort B: AMG 386 and topotecan)\].

Experimental: Part 2 - The decision on declaration of a safe and tolerable dose during part 1 will lead to part 2 (cohort A: liposomal doxorubicin + AMG 386 MTD (max tolerated dose) of part 1, cohort B: Topotecan + AMG 386 MTD (max tolerated dose) of part 1


Treatment: Drugs: A1: AMG 386 10 mg/kg + Liposomal doxorubicin
Liposomal doxorubicin 50 mg/m2 IV Q4W in combination with AMG 386 10 mg/kg IV QW

Treatment: Drugs: A3: AMG 386 15mg/kg + Liposomal doxorubicin
A3: AMG 386 15 mg/kg IV QW + Liposomal doxorubicin 50 mg/m2 IV Q4W

Treatment: Drugs: B1: AMG 386 10 mg/kg + Topotecan
B1: AMG 386 10 mg/kg IV QW + Topotecan 4 mg/m2 IV days 1, 8, 15, of a 28 day dosing schedule

Treatment: Drugs: B3: AMG 386 15mg/kg + Topotecan
AMG 386 15mg/kg IV QW + Topotecan 4mg/m2 IV days 1, 8, 15 of a 28 day dosing schedule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary objective is to identify the incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicity in subjects treated with AMG 386 + pegylated liposomal doxorubicin (cohort A) and with AMG 386 + topotecan
Timepoint [1] 0 0
first 4 weeks of treatment
Secondary outcome [1] 0 0
To evaluate the treatment effect as measured by: objective response rate (ORR), duration of response (DOR), PFS, change in tumor burden, CA 125 Response and Progression by GCIG and CA-125 duration of response
Timepoint [1] 0 0
Treatment and follow-up phase of study
Secondary outcome [2] 0 0
To evaluate the incidence of adverse events and clinical laboratory abnormalities not defined as DLTs.
Timepoint [2] 0 0
first 4 weeks of treatment
Secondary outcome [3] 0 0
To determine the pharmacokinetics of pegylated liposomal doxorubicin (and its metabolite, doxorubicinol), topotecan and AMG 386 (Cmax, AUC, and Cmin for intensive assessment; Cmax and Cmin for sparse assessment).
Timepoint [3] 0 0
Treatment and follow-up phase of study
Secondary outcome [4] 0 0
To estimate the incidence of anti AMG 386 antibody formation.
Timepoint [4] 0 0
Treatment and follow-up phase of study

Eligibility
Key inclusion criteria
* Histologically or cytologically documented recurrent invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer
* Subjects must have received at least one platinum containing regimen
* Radiographically documented progression per RECIST criteria with modifications or progression of CA 125 as adopted by GCIG during or subsequent to the last chemotherapy regimen
* Subjects may include those with measurable or non measurable disease
* All scans and x-rays used to document measurable or non measurable disease must be done within 28 days prior to enrollment
* Female 18 years of age or older at the time the written informed consent is obtained
* GOG Performance Status of 0 or 1
* Left Ventricular Ejection Fraction (LVEF) >= institutional lower limit of normal for subjects assigned to cohort A only
* Adequate organ function as assessed by laboratory studies (hematological and chemistries)
* Life expectancy >= 3 months (per investigator opinion)
* 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 double barrier non hormonal method of contraception from signing the informed consent through 6 months after last dose of study drug
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects believed to be a higher than average risk of bowel perforation. This includes 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
* Previous abdominal /or pelvic external beam radiotherapy
* Known history of central nervous system metastases
* Subjects with a history of prior malignancy, except:

* Malignancy treated with curative intent and with no known active disease present for >= 3 years before study day 1 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
* Prior myeloablative high dose chemotherapy with allogeneic or autologous stem cell (or bone marrow) transplant
* History of arterial or deep venous thromboembolism within 12 months prior to enrollment
* Clinically significant cardiac disease within 12 months prior to enrollment
* Prior treatment with doxorubicin or pegylated liposomal doxorubicin (cohort A subjects) and topotecan (cohort B subjects)
* Current or within 30 days prior to enrollment treatment with immune modulators such as systemic cyclosporine and tacrolimus

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Parallel
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
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
Accrual to date
Final
103
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Footscray
Recruitment hospital [3] 0 0
Research Site - Parkville
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3011 - Footscray
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
North Dakota
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
Belgium
State/province [9] 0 0
Leuven
Country [10] 0 0
Belgium
State/province [10] 0 0
Liège
Country [11] 0 0
Belgium
State/province [11] 0 0
Liège
Country [12] 0 0
Belgium
State/province [12] 0 0
Wilrijk

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/NCT00770536