A Trial of Cediranib in the Treatment of Patients With Alveolar Soft Part Sarcoma (CASPS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Institute of Cancer Research, United Kingdom
Sponsor:
Collaborator:
Royal Marsden NHS Foundation Trust
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier:
NCT01337401
First received: April 11, 2011
Last updated: October 12, 2012
Last verified: October 2012
  Purpose

The study is a two-arm, randomised, double-blind, international, multi-centre phase II trial of cediranib in Alveolar Soft Part Sarcoma (ASPS).

The study aims to confirm the ability of cediranib to halt disease progression in patients with metastatic ASPS, as measured by the change in tumour size at 24 weeks after randomisation, and to produce objective response according to RECIST criteria.


Condition Intervention Phase
Alveolar Soft-part Sarcoma
Drug: Cediranib
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Cediranib in the Treatment of Patients With Alveolar Soft Part Sarcoma (CASPS)

Resource links provided by NLM:


Further study details as provided by Institute of Cancer Research, United Kingdom:

Primary Outcome Measures:
  • To evaluate the efficacy of cediranib in the treatment of ASPS by measuring the percentage change in the sum of target marker lesion diameters from randomisation to week 24 (or progression if sooner) compared to treatment with placebo. [ Time Frame: 24 Weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate at week 24, best response using RECISTv1.1 and best reduction (%) in tumour size [ Time Frame: 24 Weeks of treatment ] [ Designated as safety issue: No ]
  • Progression-free survival and percentage alive and progression-free at 12 months (APF12) [ Time Frame: 12 months of treatment ] [ Designated as safety issue: No ]
  • Length of Overall survival [ Time Frame: Patients will be followed up every 12 weeks ] [ Designated as safety issue: No ]
  • The safety and tolerability profile of cediranib in patients with ASPS [ Time Frame: Assessments will be made at every study visit (8-12 weekly) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: May 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Blinded Cediranib Drug: Cediranib
30mg once daily, oral until disease progression
Placebo Comparator: Blinded Placebo Drug: Placebo
30mg, once daily, oral until 24 weeks or disease progression if sooner

Detailed Description:

Patients aged 16 years and older with a histologically confirmed diagnosis of ASPS will be recruited. Eligible patients will be randomised to receive cediranib (30 mg daily po) or placebo (30 mg daily po) in a 2:1 ratio. At 24 weeks post randomisation, treatment will be unblinded after which time all patients on placebo and those who have not progressed on active treatment will be given cediranib. Treatment will then continue until objective disease progression or death.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed diagnosis of ASPS (central confirmation not required at study entry)
  2. Age 16 years and older
  3. Availability of archived tissue blocks or unstained slides to enable confirmation of t(X;17) translocation
  4. ECOG Performance Status of 0-1
  5. Life expectancy of >12 weeks
  6. Progressive disease within 6 months prior to randomisation
  7. Measurable metastatic disease using RECISTv1.1, i.e. at least one lesion 10 mm in diameter (15 mm in short axis for nodal lesions) assessable by spiral CT (or MRI for brain metastases).
  8. Patients with brain metastases are permitted provided disease is controlled with a stable dose of corticosteroid and/or non-enzyme inducing anticonvulsant
  9. The capacity to understand the patient information sheet and ability to provide written informed consent
  10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
  11. Able to swallow and retain oral medication

Exclusion Criteria:

  1. Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count ≤1.5 x 109/L or platelet count ≤100 x 109/L
  2. Serum bilirubin ≥ 1.5 x ULN (unless Gilbert's syndrome)
  3. ALT or AST ≥ 2.5 x ULN. If liver metastases are present, ALT or AST > 5 x ULN
  4. Serum creatinine > 1.5 x ULN or a creatinine clearance (calculated or measured) of ≤ 50mL/min
  5. Greater than +1 proteinuria unless urinary protein < 1.5g in a 24 hr period or protein/creatinine ratio < 1.5.
  6. History of significant gastrointestinal impairment, as judged by the Investigator, that would significantly affect the absorption of cediranib.
  7. Patients with a history of poorly controlled hypertension with resting blood pressure >150/100 mmHg in the presence or absence of a stable regimen of anti-hypertensive therapy.
  8. Any evidence of severe or uncontrolled co-morbidities e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease, or active and uncontrolled infection.
  9. Evidence of prolonged QTc >480 msec (using Bazetts correction, for which the formula is: QTc = QT/√RR) or history of familial long QT syndrome.
  10. Significant recent haemorrhage (>30mL bleeding/episode in previous 3 months) or haemoptysis (>5mL fresh blood in previous 4 weeks).
  11. Major thoracic or abdominal surgery in the 14 days prior to entry into the study, or a surgical incision that is not fully healed.
  12. Pregnant or breast-feeding women; women of childbearing potential with a positive pregnancy test prior to receiving study medication; women the intention of pregnancy during study treatment; women of child bearing potential unwilling to have a urine or serum pregnancy test prior to study entry (even if surgically sterilised).
  13. Men and women of childbearing potential unwilling to use adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilisation) for the duration of the study and should continue such precautions for 2 weeks after receiving the last study treatment.
  14. History of anticancer (including investigational, non-registered) treatment in the four weeks prior to first dose of cediranib, with the exception of palliative radiotherapy for symptom control.
  15. Known hypersensitivity to cediranib or any of its excipients.
  16. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years, unless the patient has been disease free for 2 years and there is a tissue diagnosis of the primary cancer of interest from a target lesion.
  17. Other concomitant anti-cancer therapy (including LHRH agonists) except steroids
  18. Recent history of thrombosis
  19. Patients with brain metastases if they are symptomatic requiring increasing steroids in the previous six weeks to study entry or those with evidence of recent and/or active bleeding, or those causing uncontrolled seizures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337401

Contacts
Contact: CASPS Trial Manager 0208 722 4152 casps-icrctsu@icr.ac.uk

Locations
Australia
Princess Alexandra Hospital Recruiting
Brisbane, Australia
Royal Prince Alfred Hospital Recruiting
Sydney, Australia
United Kingdom
Bristol Haematology and Oncology Centre Recruiting
Bristol, United Kingdom
University College London Hospital Recruiting
London, United Kingdom
Royal Marsden Hospital Recruiting
London, United Kingdom
Christie Hospital Recruiting
Manchester, United Kingdom
Royal Victoria Infirmary/Freeman Hospital Recruiting
Newcastle-Upon-Tyne, United Kingdom
Nottingham University Hospitals Recruiting
Nottingham, United Kingdom
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Royal Marsden NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT01337401     History of Changes
Other Study ID Numbers: ICR-CTSU/2010/10027, 2010-021163-33, CRUK/10/021, ISRCTN63733470, ISSRECE0036
Study First Received: April 11, 2011
Last Updated: October 12, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Institute of Cancer Research, United Kingdom:
Cediranib
ASPS
Sarcoma

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Alveolar Soft Part
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Muscle Tissue
Cediranib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014