Saracatinib (AZD0530) plus weekly paclitaxel in platinum-resistant ovarian, fallopian tube or primary peritoneal cancer

Phase 2

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Gynaecological Cancer; Disease: Ovary; Cancer; Ovarian cancer

• Registration Number: ISRCTN32163062
• Lead Sponsor: niversity College London (UCL) (UK)

Brief Summary

2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25070546 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-29
• Study Completion: 2012-05-01
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 107

Inclusion Criteria

1. Confirmed relapsed ovarian, fallopian tube or primary peritoneal cancer AND patients who have relapsed in the platinum-resistant (progression must not be based on CA125 alone) time-frame, i.e. have progressed within 6 months of platinum therapy
2. All patients must have formalin-fixed paraffin-embedded (FFPE) tissue available for translational research: this tissue may be tissue taken at original diagnosis
3. Patients need not have received prior taxane; if patients have received prior taxane, the interval since treatment must be known. Patients will be stratified as less than 6 months OR at least 6 months taxane interval/no prior taxane.
4. Patients will generally have received at least two lines of prior chemotherapy, but may enter if they have relapsed within 6 months of first-line therapy. Patients may have received prior liposomal doxorubicin, although this is NOT a requirement. The treatment immediately prior to study entry need not be platinum-based.
5. Measurable or evaluable disease (if not measurable by Response Evaluation Criteria in Solid Tumours version 1.1 [RECIST v1.1] criteria, must be evaluable by CA125 [GCIG criteria])
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2
7. Adequate haematological and biochemical function as follows:
7.1. Granulocyte count greater than 1.5 x 10^9/l
7.2. Platelet count greater than 100 x 10^9/l
7.3. Haemoglobin (Hb) greater than 9.0 g/dl
7.4. Serum creatinine less than 1.5 x upper limit of normal (ULN)
7.5. Bilirubin less than 1.5 x ULN. In cases of known Gilbert's syndrome, bilirubin less than 2 x ULN is allowed
7.6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) less than 2.5 x ULN
7.7. Alkaline phosphatase (ALP) less than 5 x ULN
7.8. Prothrombin and activated partial thromboplastin times less than 1.5 x ULN
8. Willingness to consent to take part in Level 1 of the translational sub-study, as per section 19.0 of the protocol (this is NOT optional)

Exclusion Criteria

1. Prior administration of weekly paclitaxel
2. Tumours of malignant mixed mesodermal (MMMT) or mucinous types
3. Unresolved bowel obstruction
4. Chemotherapy within the preceding 3 weeks
5. Radiotherapy within the preceding 3 weeks
6. Treatment with any investigational agent within the preceding 4 weeks or within 5 half-lives of the investigational agent, whichever is longer
7. Known leptomeningeal involvement or intracranial disease
8. Evidence of interstitial lung disease (bilateral, diffuse, parenchymal lung disease)
9. Resting electrocardiogram (ECG) with measurable QTc interval of greater than 480 msec at two or more time points within a 24-hour period
10. Pregnant or lactating females
11. Fertile women of childbearing potential not willing to use adequate contraception for the duration of trial treatment and for at least 30 days after the last administration of saracatinib +/- paclitaxel
12. Inability or unwillingness to give informed consent
13. Ongoing active infection or a documented history of human immunodeficiency virus (HIV) infection, hepatitis B or C
14. Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease
15. Concurrent autoimmune disorder, e.g. systemic lupus or any demyelinating disease
16. Use of immunosuppressive therapy or corticosteroids taken within the 4 weeks prior to study entry and during the treatment period

Study & Design

• Study Type: Interventional
• Study Design: Not specified