Recurrent Ovarian CancerPhase 1ProGem2NCT02303912
Safety and Efficacy Study of Nuc-1031 and Carboplatin Combination to Treat Recurrent Ovarian Cancer
A Phase 1 study testing Nuc-1031 and Carboplatin in people with Recurrent Ovarian Cancer, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
A first in human experimental treatment in which an experimental medicine,Nuc-1031, is used in combination with a standard cancer medicine, carboplatin, to treat ovarian cancer which reappear after standard cancer treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Ovarian Cancer
- What is being tested?
- Nuc-1031 and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to 23 Jan 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed written informed consent.
- Original diagnosis and/or histological confirmation of relapsed epithelial ovarian, fallopian tube or primary peritoneal cancer.
- Relapse ≤24 months from completion of platinum (carboplatin or cisplatin) or platinum-containing regimen.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Measurable disease as defined by Response Evaluation Criteria In Solid Tumours (RECIST) criteria version 1.1; January 2009 and/or evaluable disease (evaluable: cytologically or radiologically detectable disease such as ascites, peritoneal deposits, or lesions which do not fulfill RECIST criteria version 1.1 for measurable disease) [1,2]. Participants for whom disease and response to therapy can be monitored by serum Cancer Antigen 125 (CA125) levels will also be eligible.
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- Adequate bone marrow function as defined by: White Blood Cells of ≥ 3 x109/L, Absolute Neutrophil Count (ANC) of ≥ 2.0 x 109/L, platelet count of ≥ 100.0 x 109/L, and haemoglobin of ≥ 9 g/dL.
- Adequate liver function, as determined by: Serum total bilirubin ≤1.5 x Upper Limit of Normal [(ULN), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN, albumin ≥ 30g/L.
- Adequate renal function assessed as glomerular filtration rate(GFR) ≥ 60 mL/min using Cr51-ethylenediaminetetraacetic acid (EDTA) method.
- Ability to comply with protocol requirements.
- Participants must be postmenopausal (12 months of amenorrhea), surgically sterile or they must agree to use a physical method of contraception. Oral or injectable contraceptive agents cannot be the sole method of contraception. Participants of child-bearing potential must have a negative serum pregnancy test within seven days prior to the first study drug administration.
Who cannot join
- History of allergic reactions attributed to previous gemcitabine treatment.
- Previous treatment with Nuc-1031.
- History of allergic reactions attributed to previous carboplatin treatment.
- Symptomatic Central Nervous System (CNS) or leptomeningeal metastases.
- Prior chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy for bone pain), or immunotherapy within 28 days of first receipt of study drug (within 6 weeks for nitrosoureas and mitomycin C). Hormone therapy within 14 days of first receipt of study drug.
- Prior toxicities from chemotherapy or radiotherapy which have not regressed to Grade ≤ 1 severity [National Cancer Institute -Common Terminology Criteria for Adverse Events, (NCI-CTCAE) version 4.03] except for neuropathy and alopecia.
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- Another active cancer (excluding basal cell carcinoma) within the last 3 years.
- Participants with uncontrolled concomitant illness or active infection requiring IV antibiotics.
- Participants with serious illnesses, medical conditions, or other medical history, including laboratory results, which, in the investigator's opinion, would be likely to interfere with a their participation in the study, or with the interpretation of the results.
- Known Human Immunodeficiency Virus (HIV) or known active Hepatitis B or C.
- Any condition (e.g., known or suspected poor compliance, psychological instability, geographical location, etc.) that, in the judgment of the investigator, may affect the participant's ability to sign the informed consent and undergo study procedures.
- Currently pregnant, lactating or breastfeeding
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Garry Weston Cancer Centre, Hammersmith Hospital
London, W12 0HS
About this study
Official title: Phase 1B Open Label Study to Assess the Safety, Pharmacokinetics and Clinical Activity of Nuc-1031 Given on Days 1 & 8 With Carboplatin on Day 1, q3-weekly for 6 Cycles in Participants With Recurrent Ovarian Cancer.
A first in human experimental treatment in which an experimental medicine,Nuc-1031, is used in combination with a standard cancer medicine, carboplatin, to treat ovarian cancer which reappear after standard cancer treatment. The aim of the trial is to determine safety, effectiveness, and clinical activity of this combination treatment.
Read the detailed description
Nuc-1031 and carboplatin combination is a new experimental treatment for ovarian cancer which reappear after standard chemotherapy. Chemotherapy is the name for drug treatments to kill or control the growth of cancer cells. Although there is some evidence from laboratory and clinical studies that Nuc-1031 is effective in the treatment of ovarian cancer, it has not yet been tested in combination with another chemotherapy drug. So this combination treatment is classed as a first in human study(Phase1B). The aim of the study is to investigate whether adding Nuc-1031 to carboplatin can improve the benefits of chemotherapy.
Other purposes are to find out whether Nuc-1031 is safe to give with carboplatin, to identify the correct dose of Nuc-1031 when given with carboplatin and establish how effective the combination is at treating ovarian cancer. This study is also designed to enable us to find out whether Nuc-1031 adds further benefit, over and above that achieved by carboplatin alone, when treating ovarian cancer. and carboplatin combination will be given in six cycles. Each cycle is 3 weeks long. On first day of first week of each cycle (day1), selected study participants will receive one dose of both Nuc-1031 and Carboplatin chemotherapy. Following this, the study participant will receive a second dose of Nuc-1031 alone on first day of second week (day 8). This schedule will be repeated every 3 weeks for 6 cycles.
- Conditions
- Recurrent Ovarian Cancer
- Being tested
- Nuc-1031 and Carboplatin
- Keywords
- relapsed epithelial ovarian cancer,, relapsed fallopian tube cancer, relapsed primary peritoneal cancer.
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nuc-1031 and CarboplatinDrug
Nuc-1031 IV injection on day 1 and day 8 repeated every 21 days Carboplatin IV infusion on day 1 repeated every 21 days (Total 6 cycles)
| Study group | Role | What they receive |
|---|---|---|
| Open label dose escalation | Other | Nuc-1031 IV injection on day 1 and day 8 repeated every 21 days Carboplatin IV infusion on day 1 repeated every 21 days.
Dose escalation will be done using 3+3 dose escalation design Receives: Drug: Nuc-1031 and Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the Recommended Phase II Dose (RP2D) of Nuc-1031 and carboplatin when administered in combination.
Measured: 1 year
Secondary outcomes (5)
To evaluate the safety and tolerability of Nuc-1031 administered in combination with carboplatin measured by adverse events (AE) and changes from baseline in vital signs, clinical laboratory parameters, and electrocardiography (ECG) assessments.
Measured: 1 year
To evaluate the objective response rate (ORR) of Nuc-1031 administered in combination with carboplatin in participants with recurrent ovarian cancer.
Measured: 1 year
To evaluate the clinical benefit rate (CBR) of Nuc-1031 administered in combination with carboplatin in participants with recurrent ovarian cancer.
Measured: 1 year
To evaluate the progression free survival (PFS) of participants with recurrent ovarian cancer treated with Nuc-1031 in combination with carboplatin.
Measured: 1 year
To evaluate Overall Best Response, utilising the evaluation criteria determined by the Gynecologic Cancer Intergroup (GCIG), combining the change in CA125 from baseline with RECIST 1.1 assessment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startNov 2014
- Primary completion23 Jan 2017
- Study completion23 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Blagden, MBBS, MRCP, Study director, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303912
- Sponsor's protocol ID
- PRO-002
- Other IDs
- 2014-002006-21, 2014
- Acronym
- ProGem2
- Status last verified
- May 2021
- First submitted
- 10 Oct 2014
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1B Open Label Study to Assess the Safety, Pharmacokinetics and Clinical Activity of Nuc-1031 Given on Days 1 & 8 With Carboplatin on Day 1, q3-weekly for 6 Cycles in Participants With Recurrent Ovarian Cancer.
- ClinicalTrials.gov ID
- NCT02303912
- Acronym / sponsor ID
- ProGem2 / PRO-002
- Conditions
- Recurrent Ovarian Cancer
- Keywords
- relapsed epithelial ovarian cancer,, relapsed fallopian tube cancer, relapsed primary peritoneal cancer.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 23 Jan 2017 (actual)
- Study completion
- 23 Jan 2017 (actual)
- First posted
- 1 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A first in human experimental treatment in which an experimental medicine,Nuc-1031, is used in combination with a standard cancer medicine, carboplatin, to treat ovarian cancer which reappear after standard cancer treatment. The aim of the trial is to determine safety, effectiveness, and clinical activity of this combination treatment.
Detailed description
Nuc-1031 and carboplatin combination is a new experimental treatment for ovarian cancer which reappear after standard chemotherapy. Chemotherapy is the name for drug treatments to kill or control the growth of cancer cells. Although there is some evidence from laboratory and clinical studies that Nuc-1031 is effective in the treatment of ovarian cancer, it has not yet been tested in combination with another chemotherapy drug. So this combination treatment is classed as a first in human study(Phase1B). The aim of the study is to investigate whether adding Nuc-1031 to carboplatin can improve the benefits of chemotherapy.
Other purposes are to find out whether Nuc-1031 is safe to give with carboplatin, to identify the correct dose of Nuc-1031 when given with carboplatin and establish how effective the combination is at treating ovarian cancer. This study is also designed to enable us to find out whether Nuc-1031 adds further benefit, over and above that achieved by carboplatin alone, when treating ovarian cancer. and carboplatin combination will be given in six cycles. Each cycle is 3 weeks long. On first day of first week of each cycle (day1), selected study participants will receive one dose of both Nuc-1031 and Carboplatin chemotherapy. Following this, the study participant will receive a second dose of Nuc-1031 alone on first day of second week (day 8). This schedule will be repeated every 3 weeks for 6 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label dose escalation | Other | Drug: Nuc-1031 and CarboplatinNuc-1031 IV injection on day 1 and day 8 repeated every 21 days Carboplatin IV infusion on day 1 repeated every 21 days. Dose escalation will be done using 3+3 dose escalation design |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provision of signed written informed consent.
- Original diagnosis and/or histological confirmation of relapsed epithelial ovarian, fallopian tube or primary peritoneal cancer.
- Relapse ≤24 months from completion of platinum (carboplatin or cisplatin) or platinum-containing regimen.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Key exclusion criteria (12 listed)
- History of allergic reactions attributed to previous gemcitabine treatment.
- Previous treatment with Nuc-1031.
- History of allergic reactions attributed to previous carboplatin treatment.
- Symptomatic Central Nervous System (CNS) or leptomeningeal metastases.
- Prior chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy for bone pain), or immunotherapy within 28 days of first receipt of study drug (within 6 weeks for nitrosoureas and mitomycin C). Hormone therapy within 14 days of first receipt of study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nuc-1031 and CarboplatinNuc-1031 IV injection on day 1 and day 8 repeated every 21 days Carboplatin IV infusion on day 1 repeated every 21 days (Total 6 cycles) | Drug | Open label dose escalation |
Primary outcome
To determine the Recommended Phase II Dose (RP2D) of Nuc-1031 and carboplatin when administered in combination.
Time frame: 1 year
5 secondary outcomes
To evaluate the safety and tolerability of Nuc-1031 administered in combination with carboplatin measured by adverse events (AE) and changes from baseline in vital signs, clinical laboratory parameters, and electrocardiography (ECG) assessments.
Time frame: 1 year
To evaluate the objective response rate (ORR) of Nuc-1031 administered in combination with carboplatin in participants with recurrent ovarian cancer.
Time frame: 1 year
To evaluate the clinical benefit rate (CBR) of Nuc-1031 administered in combination with carboplatin in participants with recurrent ovarian cancer.
Time frame: 1 year
To evaluate the progression free survival (PFS) of participants with recurrent ovarian cancer treated with Nuc-1031 in combination with carboplatin.
Time frame: 1 year
To evaluate Overall Best Response, utilising the evaluation criteria determined by the Gynecologic Cancer Intergroup (GCIG), combining the change in CA125 from baseline with RECIST 1.1 assessment
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Blagden, MBBS, MRCP study director
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nuc-1031 and Carboplatin in people with Recurrent Ovarian Cancer, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the Recommended Phase II Dose (RP2D) of Nuc-1031 and carboplatin when administered in combination. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021; AzTrials last refreshed its copy on 8 Nov 2026.