Epithelial Ovarian CancerPhase 1OVMETNCT02312661
Study of Metformin With Carboplatin/Paclitaxel Chemotherapy in Patients With Advanced Ovarian Cancer
A Phase 1 study testing Metformin, Carboplatin and Paclitaxel in people with Epithelial Ovarian Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Molecularly targeted agents which inhibit the mammalian target of rapamycin (mTOR) pathway and/or circumvent p53 in the induction of apoptosis are exciting potential targets in ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- Metformin, Carboplatin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Oct 2015to Nov 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
- Patients with advanced stage (FIGO III-IV), histologically confirmed and documented epithelial ovarian carcinoma
- Patients eligible for neo-adjuvant carboplatin/paclitaxel chemotherapy prior to surgical debulking OR patients with relapsed or progressive ovarian cancer after initial treatment eligible for palliative carboplatin/paclitaxel chemotherapy
- Eastern Cooperative Oncology Group-performance status (ECOG-PS) of 0-2
- Age ≥ 18 years
- Laboratory Requirements - within 7 days prior to enrolment:
- absolute neutrophil count (ANC) ≥1.5 x 109/L
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- platelets > 100 x 109/L
- hemoglobin >9g/dl. Patients may be transfused or use erythropoietin to maintain hemoglobin values ≥ 9 g/dl.
- hepatic function: bilirubin ≤1.5×upper limit of normal (ULN), aspartate aminotransferase (AST)/ALT≤2.5×ULN
- estimated creatinine clearance ≥ 60ml/min
- Before patient registration/randomization, written informed consent for the trial must be given according to International Conference on Harmonisation (ICH)/ good clinical practice (GCP), and national/local regulations.
Who cannot join
- Current or recent (within 30 days of first study dosing) treatment with another investigational drug or participation in another investigational study.
- Metformin within 4 weeks prior to enrolment.
- Symptomatic central nervous system (CNS) metastasis
- Pre-existing peripheral neuropathy ≥ Common toxicity criteria (CTC) grade 2.
- Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start.
- Women of childbearing potential (defined as <2 years after last menstruation and not surgically sterile) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly) during the study and for 6 months after the last study medication.
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- Known hypersensitivity to any of the study drugs or excipients.
- Serious active infection requiring i.v. antibiotics at enrolment.
- Unstable medical conditions.
- Evidence of any other medical conditions, physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment related complications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Ib Study of Metformin in Combination With Carboplatin/Paclitaxel Chemotherapy in Patients With Advanced Ovarian Cancer
Molecularly targeted agents which inhibit the mammalian target of rapamycin (mTOR) pathway and/or circumvent p53 in the induction of apoptosis are exciting potential targets in ovarian cancer. Metformin is a biguanide, widely used in the treatment of type 2 diabetes mellitus, that has shown anti-cancer activity in preclinical studies. The main mechanism of metformin's effect is mTOR pathway inhibition and, in addition, it has been shown to circumvent p53-induced apoptosis making it an exciting, potentially effective drug in ovarian cancer.
Read the detailed description
A phase Ib, single-centre, dose-escalation trial with a traditional escalation rule with fixed dose levels ("3 + 3" rule). The recommended phase II dose will be defined as the maximum predefined dose level at which 0 of 3 or ≤ 1 of 6 subjects experience a drug-related dose limiting toxicity (DLT) during cycle 1 and 2 of treatment. An estimated 10-20 patients will be required for this study.
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- Metformin, Carboplatin, Paclitaxel
- Keywords
- ovarian cancer, metformin, carboplatin, paclitaxel
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin in increasing doses will be added to carboplatin/paclitaxel chemotherapy
CarboplatinDrug
Intravenous carboplatin chemotherapy in three-weekly cycles, for a maximum of 6 cycles
PaclitaxelDrug
Intravenous paclitaxel chemotherapy in three-weekly cycles, for a maximum of 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Carboplatin / paclitaxel /metformin | Experimental | Three-weekly cycles of carboplatin/paclitaxel chemotherapy in combination with metformin treatment Receives: Drug: Metformin; Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events as a measure of safety and tolerability
Data will be used to determine recommended phase 2 dose
Measured: 1-2 years
Secondary outcomes (1)
Pharmacokinetics (AUC, Tmax,Cmax) of carboplatin and paclitaxel chemotherapie
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study start5 Oct 2015
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312661
- Sponsor's protocol ID
- 30102012
- Acronym
- OVMET
- Status last verified
- May 2024
- First submitted
- 28 Nov 2014
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Study of Metformin in Combination With Carboplatin/Paclitaxel Chemotherapy in Patients With Advanced Ovarian Cancer
- ClinicalTrials.gov ID
- NCT02312661
- Acronym / sponsor ID
- OVMET / 30102012
- Conditions
- Epithelial Ovarian Cancer
- Keywords
- ovarian cancer, metformin, carboplatin, paclitaxel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 5 Oct 2015 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 9 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.
Molecularly targeted agents which inhibit the mammalian target of rapamycin (mTOR) pathway and/or circumvent p53 in the induction of apoptosis are exciting potential targets in ovarian cancer. Metformin is a biguanide, widely used in the treatment of type 2 diabetes mellitus, that has shown anti-cancer activity in preclinical studies. The main mechanism of metformin's effect is mTOR pathway inhibition and, in addition, it has been shown to circumvent p53-induced apoptosis making it an exciting, potentially effective drug in ovarian cancer.
Detailed description
A phase Ib, single-centre, dose-escalation trial with a traditional escalation rule with fixed dose levels ("3 + 3" rule). The recommended phase II dose will be defined as the maximum predefined dose level at which 0 of 3 or ≤ 1 of 6 subjects experience a drug-related dose limiting toxicity (DLT) during cycle 1 and 2 of treatment. An estimated 10-20 patients will be required for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carboplatin / paclitaxel /metformin | Experimental | Drug: Metformin, Drug: Carboplatin, Drug: PaclitaxelThree-weekly cycles of carboplatin/paclitaxel chemotherapy in combination with metformin treatment |
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)
- Patients with advanced stage (FIGO III-IV), histologically confirmed and documented epithelial ovarian carcinoma
- Patients eligible for neo-adjuvant carboplatin/paclitaxel chemotherapy prior to surgical debulking OR patients with relapsed or progressive ovarian cancer after initial treatment eligible for palliative carboplatin/paclitaxel chemotherapy
- Eastern Cooperative Oncology Group-performance status (ECOG-PS) of 0-2
- Age ≥ 18 years
- Laboratory Requirements - within 7 days prior to enrolment:
Key exclusion criteria (10 listed)
- Current or recent (within 30 days of first study dosing) treatment with another investigational drug or participation in another investigational study.
- Metformin within 4 weeks prior to enrolment.
- Symptomatic central nervous system (CNS) metastasis
- Pre-existing peripheral neuropathy ≥ Common toxicity criteria (CTC) grade 2.
- Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start.
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 |
|---|---|---|
| MetforminMetformin in increasing doses will be added to carboplatin/paclitaxel chemotherapy | Drug | Carboplatin / paclitaxel /metformin |
| CarboplatinIntravenous carboplatin chemotherapy in three-weekly cycles, for a maximum of 6 cycles | Drug | Carboplatin / paclitaxel /metformin |
| PaclitaxelIntravenous paclitaxel chemotherapy in three-weekly cycles, for a maximum of 6 cycles | Drug | Carboplatin / paclitaxel /metformin |
Primary outcome
Number of participants with Adverse Events as a measure of safety and tolerability
Time frame: 1-2 years
Data will be used to determine recommended phase 2 dose
1 secondary outcome
Pharmacokinetics (AUC, Tmax,Cmax) of carboplatin and paclitaxel chemotherapie
Time frame: 1-2 years
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 6 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Metformin, Carboplatin and Paclitaxel in people with Epithelial Ovarian Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
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 10 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 6 May 2024. 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 Netherlands. 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?
Number of participants with Adverse Events as a measure of safety and tolerability (time frame: 1-2 years). 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 6 May 2024.