Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05080556
Other study ID # 136618
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 24, 2023
Est. completion date November 1, 2027

Study information

Verified date November 2023
Source University College, London
Contact ACTOv Trial Coordinator
Phone 02076794466
Email ctc.actov@ucl.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

ACTOv will compare standard 3-weekly carboplatin (AUC5), to carboplatin delivered according to an AT regimen. The AT regimen will modify carboplatin dose according to changes in the clinical-standard serum biomarker CA125 as a proxy measure of total tumour burden and an individual patient's response to the most recent chemotherapy treatment. AT could prolong sensitivity to carboplatin and extend tumour control, while simultaneously reducing chemotherapy dose and drug-induced toxicity. Carboplatin is a low cost and low toxicity drug that has an enduring and central role in ovarian cancer treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date November 1, 2027
Est. primary completion date November 1, 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Female patients aged =18 years 2. ECOG performance status 0-2 3. Histologically proven diagnosis of high grade serous or high grade endometrioid carcinoma of the ovary, fallopian tube or peritoneum 4. Most recent regimen must have included platinum (cisplatin or carboplatin) 5. Must have previously received a PARP inhibitor 6. 6. Must have responded to most recent platinum treatment by CT or MRI or by GCIG CA125 response criteria 7. Pre-trial CT or MRI-confirmed disease relapse = 6 months after day 1 of the last cycle of platinum-containing chemotherapy (cisplatin or carboplatin) and requiring treatment with further platinum-based chemotherapy 8. Measurable disease by RECIST v1.1 on a CT scan conducted within 28 days prior to randomisation (Patient with non-measurable disease could be eligible if they meet GCIG CA125 progression criteria) 9. CA125 = 100iU/l at screening 10. Agree to provide additional research blood samples at the same time as blood draws prior to each carboplatin treatment, 6-weekly during surveillance and at 12- weekly follow-up visit 11. Expected to be able to commence treatment within 28 days post randomisation 12. Adequate bone marrow function 13. Adequate liver function 14. Adequate renal function 15. Postmenopausal or women of child-bearing potential (WOCBP) must agree to have an urine or serum pregnancy test at screening for evidence of non-childbearing status and prior to trial treatment and use adequate contraception for duration of trial 16. Willing and able to give consent and able to comply with treatment and follow up schedule Exclusion Criteria: 1. Non-epithelial ovarian cancer, carcinosarcoma, low-grade serous and endometrioid carcinomas, mucinous & clear-cell carcinomas 2. Patients requiring treatment with combination chemotherapy regimens 3. Patients with a known hypersensitivity to carboplatin 4. Persisting = grade 2 CTCAE v5 adverse events/ toxicity (except alopecia and neuropathy) from previous anti-cancer treatment. 5. Treatment with any other investigational agent, or participation in another interventional clinical trial within 28 days prior to randomisation. 6. Major surgery within 14 days before anticipated start of treatment and patients must have recovered from any effects of major surgery. 7. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicated the use of an investigation drug or puts the patients at high risk for treatment-related complications. 8. Other psychological, psychiatric, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results. 9. Malignancy treated within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast, Stage 1, grade 1 endometrial carcinoma. 10. Patients with symptomatic uncontrolled brain or meningeal metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. 11. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days prior to randomisation. 12. Pregnant or breast-feeding women are excluded. Women of childbearing potential will be excluded unless effective methods of contraception are used from signing of the informed consent, throughout the period of taking study treatment and for at least 6 months after last dose of trial drug(s). 13. Inability to attend or comply with treatment or follow-up scheduling.

Study Design


Intervention

Drug:
Carboplatin
Treatment in both arms will be administered intravenously (IV) every 21 days (q21D) and for a maximum of 6 cycles in Arm 1 and 12 cycles in Arm 2.

Locations

Country Name City State
United Kingdom University College London Hospitals London

Sponsors (4)

Lead Sponsor Collaborator
University College, London Anticancer Fund, Belgium, Barts & The London NHS Trust, JP Moulton Charitable Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Modified Progression Free Survival (mPFS) Measured from the date of randomisation to the date of objective progression (investigator assessed using RECIST v1.1) but comparing CT scans to the baseline CT rather than the radiological nadir), clinical progression or death from any cause (in the absence of progression) From the date of randomisation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years.
Secondary Acceptability (1/2) the number of eligible patients approached who accept randomisation and continue to receive treatment From the date of randomisation to the first dose of treatment (within 28 days from randomisation)received by patient. Measured as the number of patients approached who accept randomisation.
Secondary Acceptability (2/2) the proportion of eligible patients approached who accept randomisation and continue to receive treatment From the date of randomisation to the first dose of treatment (within 28 days from randomisation)received by patient. Measured as the percent of patients approached who accept randomisation.
Secondary Deliverability (1/2) the number of treatment cycles that are delivered as per protocol, described by trial arm Measured as the number of treatment cycles that are delivered as per protocol, described by trial arm (maximum of 6 cycles in control arm and 12 in experimental arm, approx.. 18 weeks and 36 weeks respectively). Treatment delays, reductions and omissions
Secondary Deliverability (2/2) the proportion of treatment cycles that are delivered as per protocol, described by trial arm Measured as the number of treatment cycles that are delivered as per protocol, described by trial arm (maximum of 6 cycles in control arm and 12 in experimental arm, approx.. 18 weeks and 36 weeks respectively). Treatment delays, reductions and omissions
Secondary Compliance total cumulative carboplatin dose will be calculated for each patient over time on treatment, and described by trial arm Total cumulative carboplatin dose will be calculated for each patient over time on treatment (max. of 6 cycles in control arm and 12 cycles in experimental arm, approximately 18 weeks and 36 weeks respectively
Secondary Adverse events (1/2) adverse events will be categorised using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5. The number of patients who suffer a grade 3 or 4 toxicity at any time, and the maximum grade of toxicity for each adverse event term, will be described by trial arm Adverse events will be reported between informed consent and 30 calendar days post last IMP (i.e. max. of 6 cycles in control arm and 12 cycles in experimental arm, approximately 30 days after 18 weeks or 36 weeks respectively)
Secondary Adverse events (2/2) adverse events will be categorised using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5. The percentage of patients who suffer a grade 3 or 4 toxicity at any time, and the maximum grade of toxicity for each adverse event term, will be described by trial arm Adverse events will be reported between informed consent and 30 calendar days post last IMP (i.e. max. of 6 cycles in control arm and 12 cycles in experimental arm, approximately 30 days after 18 weeks or 36 weeks respectively)
Secondary Quality of life (1/2) - EORTC questionnaire (assessing the quality of life of patients with ovarian cancer) measured using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC questionnaires): Quality of Life cancer 30 (QLQ-C30) (suitable for all cancer types) and Qualify of life questionnaire (QLQ-OV28 (ovarian cancer-specific)) in scale of 4 (1 is not very much and 4 very much) At baseline, during treatment and follow up until the first documented progression or date of death (estimate 6 or 12 months but can be up to 4 years)
Secondary Quality of life (2/2) - EQ-5D ((mobility, self-care, usual activities, pain/discomfort, anxiety/depression, a single summary index and a visual analogue scale) measured using European Quality of life questionnaire five dimensions (EQ-5D (descriptive profile of health state)) in scale of 5 (1 is no problem and 5 is extreme problem) At baseline, during treatment and follow up until the first documented progression or date of death (estimate 6 or 12 months but can be up to 4 years)
Secondary Fear of progression measured using Fear of progression questionnaire (FOP-Q SF) in scale of 1 to 5 where 1 is never and 5 is very often At baseline, during treatment and follow up until the first documented progression or date of death (estimate 6 or 12 months but can be up to 4 years)
Secondary CA125 measured at baseline, 3-weekly during treatment, 6-weekly during surveillance and 12-weekly during follow-up Measured at baseline, 3 weekly during treatment, 6-weekly during surveillance and 12-weekly during follow-up, through study completion, an average of 1 year.
Secondary Further treatment (1/3) of patients who progress will be described by trial arm including the time-to-next treatment (measured from randomisation) Additional treatment of patients who progress will be described by trial arm, this will include the time-to-next treatment (measured from randomisation).
Secondary Further treatment (2/3) of patients who progress will be described by trial arm including the time treatment received (measured from randomisation) Additional treatment of patients who progress will be described by trial arm, this will include the time treatment received (measured from randomisation)
Secondary Further treatment (3/3) of patients who progress will be described by trial arm including the time response to this treatment (measured from randomisation) Additional treatment of patients who progress will be described by trial arm, this will include the time response to this treatment (measured from randomisation)
Secondary Overall survival measured from the date of randomisation to the date of death from any cause. Patients who are event-free will be censored at the date last seen Measured from the date of randomisation to the date of death from any cause, censored at the date last seen (estimate 2 years but can be up to 4 years)
See also
  Status Clinical Trial Phase
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Withdrawn NCT05201001 - APX005M in Patients With Recurrent Ovarian Cancer Phase 2
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT05156892 - Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer Phase 1
Suspended NCT02432378 - Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines Phase 1/Phase 2
Recruiting NCT04533763 - Living WELL: A Web-Based Program for Ovarian Cancer Survivors N/A
Active, not recruiting NCT03371693 - Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer Phase 3
Withdrawn NCT03032614 - Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients Phase 2
Completed NCT01936363 - Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer Phase 2
Completed NCT02019524 - Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients Phase 1
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Terminated NCT03146663 - NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer Phase 2