Ovarian CancerPhase 1/2NCT01133756
E7080 in Combination With Carboplatin + Gemcitabine Versus Carboplatin + Gemcitabine Alone as Second Line Therapy in Patients With Platinum-Sensitive Recurrent Ovarian Cancer by CA125
A Phase 1/2 study testing Lenvatinib, Carboplatin and Gemcitabine in people with Ovarian Cancer, run by Eisai Inc. at 1 site in United States.
Trial summary
The purpose of this study was to determine the maximum tolerated dose (MTD)/recommended Phase II dose of lenvatinib administered in combination with carboplatin and gemcitabine (Phase IB) and to evaluate the safety and tolerability of E7080 administered in combination with carboplatin and gemcitabine compared to… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Lenvatinib, Carboplatin and Gemcitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Sep 2012
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants may be in the study only if they meet all of the following criteria.
- Female participants greater than or equal to 18 years of age.
- Histologically or cytologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer that was treated with and was sensitive to one prior platinum-based chemotherapy regimen for Stage III or Stage IV disease.
- Documentation of biochemical relapse defined by CA125 criteria (measurable or non-measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST criteria), more than six months since completion of first-line platinum-based chemotherapy requiring treatment with further platinum-based chemotherapy. CA125 criteria for relapse Gynecologic Cancer Intergroup (GCIG) criteria are the finding of 2 serum CA125 levels with samples taken at least 1 week apart and no greater than 3 months apart:
- greater than or equal to 2 x ULN in participants with an elevated pre-treatment serum CA125 level followed by normalization on treatment and prior to progression OR
- greater than or equal to 2 X nadir value for participants with an elevated pre-treatment CA125 that never normalizes).
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- Gynecological Oncology Group performance status of 0 or 1
- Life expectancy greater than or equal to 3 months
- Participants must have recovered from effects of any major surgery within 28 days from the first dose of study treatment.
- Adequate hematologic, renal, liver, and coagulation system function as defined by laboratory values performed within 21 days prior to initiation of dosing.
- Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L
- Platelet count greater than or equal to 100 x 109/L
- Hemoglobin greater than or equal to 9 g/dL
- Serum creatinine less than or equal to 1.5 X ULN and/or creatinine clearance 50 dL/min
- Total serum bilirubin less than or equal to 1.5 X ULN
- Serum aspartate transaminase (AST/SGOT) or serum alanine transaminase (ALT/SGPT) less than or equal to 2.5 X ULN, and less than or equal to 5 X ULN in cases of liver metastasis
- PT/International normalized ratio (INR) less than or equal to 1.5 X ULN
- h. PTT less than or equal to 1.1 X ULN
- Blood pressure must be well-controlled (less than or equal to 140/90 mmHg at screening) with or without antihypertensive medication. Participants must have no history of hypertensive crisis or hypertensive encephalopathy;
- Participants should have a negative pregnancy test at screening in pre-menopausal women and women less than 2 years after the onset of menopause. Pre-menopausal women must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 90 days after the last dose of study drug. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for greater than or equal to 1 year;
- Before study entry, written informed consent must be obtained from participant prior to performing any study-related procedures.
Who cannot join
- Participants will not be entered in the study for any of the following reasons:
- Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives or avoidance of pregnancy measures;
- Prior anti-angiogenic therapy with anti-VEGFR inhibitors; bevacizumab is allowed;
- Prior gemcitabine;
- Participants with proteinuria greater than 1+ on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with 24-hour urine protein greater than or equal to 1 g/24 hours will be ineligible.
- Ovarian nonepithelial cancer, including malignant mixed Mullerian tumors and borderline tumors (e.g., tumors of low malignant potential);
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- Other malignancy within 5 years of randomization, with the exception of adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer, with no subsequent evidence of recurrence;
- History of, or known carcinomatous meningitis;
- Are currently receiving any other treatment for the tumor (including palliative radiotherapy) aside from control of symptoms;
- Received treatment in another clinical study within the 30 days prior to commencing study treatment or participants who have not recovered from side effects of an investigational drug to Grade less than or equal to 1, except for peripheral neuropathy (Grade 1 or 2 are permitted) or alopecia;
- Received chemotherapy, biological therapy, hormonal therapy, targeted therapy, or radiotherapy within the 30 days prior to commencing study treatment or have not recovered from all treatment-related toxicities to Grade less than or equal to 1, except for peripheral neuropathy (Grade 1 or 2 are permitted) or alopecia;
- Serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury within the 28 days prior to commencing study treatment. Minor surgery such as Portacath placement or skin biopsy is permitted if greater than or equal to 7 days have passed;
- The use of anti-coagulants such as Vitamin K antagonists, unfractionated heparin, or low molecular weight heparin;
- Refractory nausea and vomiting, malabsorption, significant bowel resection, or any other medical condition that would preclude adequate absorption or result in the inability to take oral medication;
- Significant cardiovascular impairment (history of congestive heart failure) New York Heart Association (NYHA) Grade II, unstable angina or myocardial infarction within the past 6 months, or serious cardiac arrhythmia);
- Any history of cerebral vascular accident (CVA) or transient ischemic attack (TIA) unless they have had no evidence of active disease for at least 6 months prior to randomization
- Active hemoptysis (defined as bright red blood of 1/2 teaspoon or more) within the 30 days prior to study entry;
- History of abdominal fistula, gastrointestinal perforation, or intrabdominal abscess within the 6 months prior to enrolment;
- History of bleeding diathesis or coagulopathy;
- History of an allograft requiring immunosuppression;
- Known positive human immunodeficiency virus (HIV), known surface antigen positive for hepatitis B hepatitis or C positive;
- Hypersensitivity to E7080 and/or E7080 chemical derivative; or
- Have any other uncontrolled infection or medical condition which would interfere with the conduct of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Oncology - Austin Central
Austin, Texas, 78731
About this study
Official title: An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7080 in Combination With Carboplatin + Gemcitabine Versus Carboplatin + Gemcitabine Alone as Second Line Therapy in Patients With Platinum-Sensitive Recurrent Ovarian Cancer by CA125.
The purpose of this study was to determine the maximum tolerated dose (MTD)/recommended Phase II dose of lenvatinib administered in combination with carboplatin and gemcitabine (Phase IB) and to evaluate the safety and tolerability of E7080 administered in combination with carboplatin and gemcitabine compared to carboplatin and gemcitabine alone (Phase II) in participants with platinum-sensitive recurrent ovarian cancer.
Read the detailed description
This open-label, multicenter, randomized study was to consist of a Phase 1b portion: a safety run-in period with 3 doses of lenvatinib administered in combination with carboplatin + gemcitabine; and a Phase II portion: a randomized 2-arm period. Approximately 100 participants with ovarian cancer were to be enrolled in the study (10 to 20 participants in the Phase 1b portion and 80 participants in the Phase II portion). Participants were to participate in either the Phase 1b or the Phase II portion. Participants were to receive study treatment (lenvatinib plus carboplatin + gemcitabine or carboplatin + gemcitabine) for six 21-day cycles (18 weeks). Participants who receive E7080 and experience evidence of clinical benefit (CR, PR, or SD) may continue single agent E7080 beyond 18 weeks, until the occurrence of progressive disease (PD), unacceptable toxicity, withdrawal of consent, or withdrawal by investigator, whichever occurs first.
Initially, an ascending dose schedule starting at lenvatinib 16 mg once daily on Day 1 to Day 21 was chosen for the Phase 1b portion to determine the MTD of lenvatinib administered once daily in combination with carboplatin + gemcitabine; however, due to hematologic toxicity observed in the first cohort, the lenvatinib administration schedule was changed to Days 2 to 21 in Protocol Amendment 2. Continued hematologic toxicity prompted a third protocol amendment, designed to evaluate a lower range of doses starting at lenvatinib 8 mg once daily in Protocol Amendment 3.
After three protocol amendments, recruitment into the Phase 1b portion of the study was very limited, with only one evaluable participant enrolled during the last 5 months of recruitment. Due to the limited enrollment despite significant diligence to boost enrollment and the complex study design required to manage hematologic toxicity, the study was terminated before the initiation of Phase II.
Safety was assessed by the monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs); vital signs; Gynecological Oncology Group performance status; clinical laboratory evaluations; physical examinations; and 12-lead electrocardiograms (ECGs).
- Conditions
- Ovarian Cancer
- Being tested
- Lenvatinib, Carboplatin, Gemcitabine
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenvatinibDrug
Also called Lenvima, E7080
lenvatinib (as 1mg, 4mg, and 10mg tablets) was administered orally, once daily continuously for each 21-day treatment cycle.
CarboplatinDrug
Carboplatin was to be administered on Day 1 of every 21-day cycle at a dose AUC 4 over 30 minutes.
GemcitabineDrug
Gemcitabine was to be administered on Day 1 and Day 8 of every 21-day cycle at a dose of 1000 mg/m2 over 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib plus carboplatin + gemcitabine | Experimental | Phase IB and Phase II Receives: Drug: Lenvatinib; Drug: Carboplatin; Drug: Gemcitabine |
| Carboplatin + gemcitabine | Active comparator | Phase II Receives: Drug: Carboplatin; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicity (DLT)
DLTs were defined as clinically significant adverse events occurring less than or equal to 21 days after commencing study treatment and considered to be possibly or probably related to study treatment by the Investigator. If 1 DLT occurred at any dose level, the cohort was to be expanded to include a maximum of six evaluable subjects. If 2 DLTs occurred at any dose level, the maximum tolerated dose (MTD) was to be either defined as the preceding dose, or an intermediate dose. To evaluate an intermediate dose, an additional dose cohort could be added to more accurately define the MTD.
Measured: Cycle 1 (21 days)
Secondary outcomes (2)
Biomarker CA125-based Overall Response Rate (B-ORR), Within Treatment Group
Due to the limited enrollment despite significant diligence to boost enrollment and the complex study design required to manage hematologic toxicity, the study was terminated before the initiation of Phase 2. Hence the analysis was not conducted.
Measured: Day 1 of every cycle, at end of treatment visit and every 2 months during follow-up period for patients who complete study without progressive disease.
Biomarker-based Proportion of Biomarker-Progression-Free Survival (B-PFS) at Week 12, Within Treatment Group
Due to the limited enrollment despite significant diligence to boost enrollment and the complex study design required to manage hematologic toxicity, the study was terminated before the initiation of Phase 2. Hence the analysis was not conducted.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2012
- Study completionSep 2012
Why it stopped: poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PharmaBio Development Inc.
- Responsible party
- Sponsor
- Investigators
- Harish Dave, MD, Study director, Quintiles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133756
- Sponsor's protocol ID
- E7080-701
- Other IDs
- 2009-016050-41, 2009
- Status last verified
- Oct 2016
- First submitted
- 21 May 2010
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7080 in Combination With Carboplatin + Gemcitabine Versus Carboplatin + Gemcitabine Alone as Second Line Therapy in Patients With Platinum-Sensitive Recurrent Ovarian Cancer by CA125.
- ClinicalTrials.gov ID
- NCT01133756
- Acronym / sponsor ID
- E7080-701
- Conditions
- Ovarian Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Collaborators
- PharmaBio Development Inc.
- Study start
- Mar 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 31 May 2010 (estimated)
- Results
- Posted 5 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine the maximum tolerated dose (MTD)/recommended Phase II dose of lenvatinib administered in combination with carboplatin and gemcitabine (Phase IB) and to evaluate the safety and tolerability of E7080 administered in combination with carboplatin and gemcitabine compared to carboplatin and gemcitabine alone (Phase II) in participants with platinum-sensitive recurrent ovarian cancer.
Detailed description
This open-label, multicenter, randomized study was to consist of a Phase 1b portion: a safety run-in period with 3 doses of lenvatinib administered in combination with carboplatin + gemcitabine; and a Phase II portion: a randomized 2-arm period. Approximately 100 participants with ovarian cancer were to be enrolled in the study (10 to 20 participants in the Phase 1b portion and 80 participants in the Phase II portion). Participants were to participate in either the Phase 1b or the Phase II portion. Participants were to receive study treatment (lenvatinib plus carboplatin + gemcitabine or carboplatin + gemcitabine) for six 21-day cycles (18 weeks). Participants who receive E7080 and experience evidence of clinical benefit (CR, PR, or SD) may continue single agent E7080 beyond 18 weeks, until the occurrence of progressive disease (PD), unacceptable toxicity, withdrawal of consent, or withdrawal by investigator, whichever occurs first.
Initially, an ascending dose schedule starting at lenvatinib 16 mg once daily on Day 1 to Day 21 was chosen for the Phase 1b portion to determine the MTD of lenvatinib administered once daily in combination with carboplatin + gemcitabine; however, due to hematologic toxicity observed in the first cohort, the lenvatinib administration schedule was changed to Days 2 to 21 in Protocol Amendment 2. Continued hematologic toxicity prompted a third protocol amendment, designed to evaluate a lower range of doses starting at lenvatinib 8 mg once daily in Protocol Amendment 3.
After three protocol amendments, recruitment into the Phase 1b portion of the study was very limited, with only one evaluable participant enrolled during the last 5 months of recruitment. Due to the limited enrollment despite significant diligence to boost enrollment and the complex study design required to manage hematologic toxicity, the study was terminated before the initiation of Phase II.
Safety was assessed by the monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs); vital signs; Gynecological Oncology Group performance status; clinical laboratory evaluations; physical examinations; and 12-lead electrocardiograms (ECGs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib plus carboplatin + gemcitabine | Experimental | Drug: Lenvatinib, Drug: Carboplatin, Drug: GemcitabinePhase IB and Phase II |
| Carboplatin + gemcitabine | Active comparator | Drug: Carboplatin, Drug: GemcitabinePhase II |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Participants may be in the study only if they meet all of the following criteria.
- Female participants greater than or equal to 18 years of age.
- Histologically or cytologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer that was treated with and was sensitive to one prior platinum-based chemotherapy regimen for Stage III or Stage IV disease.
- Documentation of biochemical relapse defined by CA125 criteria (measurable or non-measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST criteria), more than six months since completion of first-line platinum-based chemotherapy requiring treatment with further platinum-based chemotherapy. CA125 criteria for relapse Gynecologic Cancer Intergroup (GCIG) criteria are the finding of 2 serum CA125 levels with samples taken at least 1 week apart and no greater than 3 months apart:
- Gynecological Oncology Group performance status of 0 or 1
Key exclusion criteria (23 listed)
- Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives or avoidance of pregnancy measures;
- Prior anti-angiogenic therapy with anti-VEGFR inhibitors; bevacizumab is allowed;
- Prior gemcitabine;
- Participants with proteinuria greater than 1+ on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with 24-hour urine protein greater than or equal to 1 g/24 hours will be ineligible.
- Ovarian nonepithelial cancer, including malignant mixed Mullerian tumors and borderline tumors (e.g., tumors of low malignant potential);
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 |
|---|---|---|
| LenvatinibAlso: Lenvima, E7080lenvatinib (as 1mg, 4mg, and 10mg tablets) was administered orally, once daily continuously for each 21-day treatment cycle. | Drug | Lenvatinib plus carboplatin + gemcitabine |
| CarboplatinCarboplatin was to be administered on Day 1 of every 21-day cycle at a dose AUC 4 over 30 minutes. | Drug | Carboplatin + gemcitabine, Lenvatinib plus carboplatin + gemcitabine |
| GemcitabineGemcitabine was to be administered on Day 1 and Day 8 of every 21-day cycle at a dose of 1000 mg/m2 over 30 minutes. | Drug | Carboplatin + gemcitabine, Lenvatinib plus carboplatin + gemcitabine |
Primary outcome
Number of Participants With Dose Limiting Toxicity (DLT)
Time frame: Cycle 1 (21 days)
DLTs were defined as clinically significant adverse events occurring less than or equal to 21 days after commencing study treatment and considered to be possibly or probably related to study treatment by the Investigator. If 1 DLT occurred at any dose level, the cohort was to be expanded to include a maximum of six evaluable subjects. If 2 DLTs occurred at any dose level, the maximum tolerated dose (MTD) was to be either defined as the preceding dose, or an intermediate dose. To evaluate an intermediate dose, an additional dose cohort could be added to more accurately define the MTD.
2 secondary outcomes
Biomarker CA125-based Overall Response Rate (B-ORR), Within Treatment Group
Time frame: Day 1 of every cycle, at end of treatment visit and every 2 months during follow-up period for patients who complete study without progressive disease.
Biomarker-based Proportion of Biomarker-Progression-Free Survival (B-PFS) at Week 12, Within Treatment Group
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Harish Dave, MD study director
Quintiles, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lenvatinib, Carboplatin and Gemcitabine in people with Ovarian Cancer, run by Eisai Inc. at 1 site in United States.
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 21 inclusion and 23 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: stopped early, as of the sponsor's last update on 22 Jun 2023. 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 States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Dose Limiting Toxicity (DLT) (time frame: Cycle 1 (21 days)). 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 22 Jun 2023.