Ovarian CancerPhase 1NCT04608409
Dose Escalation of Lapatinib With Paclitaxel in Ovarian Cancer
A Phase 1 study testing Lapatinib and Paclitaxel in people with Ovarian Cancer, run by Frederick R. Ueland, M.D. at 1 site in United States.
Trial summary
This trial will be a phase I dose-escalation study of lapatinib and paclitaxel for platinum-resistant ovarian cancer, which will establish the phase II dose for subsequent efficacy trials. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Lapatinib and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2021to 17 May 2024
- Phase
- Phase 1
- 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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically or cytologically confirmed ovarian cancer who recur within 12 months of platinum-based chemotherapy
- ECOG performance status less than or equal to 2
- Adequate organ and marrow function at baseline
- ability to sign a written informed consent document
Who cannot join
- hypersensitivity to lapatinib or paclitaxel
- uncontrolled intercurrent illness
- receiving medications that inhibit or induce CYP3A4
- malabsorption syndrome
- congestive heart failure
- receiving any other anti-cancer investigational agents
- baseline neuropathy greater than Grade 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Dose-Escalation Study on the Safety of Lapatinib With Dose-Dense Paclitaxel in Patients With Platinum-Resistant Ovarian Cancer
This trial will be a phase I dose-escalation study of lapatinib and paclitaxel for platinum-resistant ovarian cancer, which will establish the phase II dose for subsequent efficacy trials.
Read the detailed description
While ABCB1 (P-glycoprotein 1) upregulation after paclitaxel administration is well known, there is currently no clinically available method for preventing or overcoming it. To develop a therapy able to prevent ABCB1 upregulation and paclitaxel resistance, several ABCB1 inhibitors have been evaluated in combination with paclitaxel in preclinical model systems. Pulsed-dose lapatinib and paclitaxel are synergistic and inhibition of ABCB1 by lapatinib increases sensitivity to paclitaxel. Lapatinib is FDA approved, orally available, and previously studied in combination with weekly paclitaxel for breast cancer at doses of 1000mg to 1250mg daily (7000-8250mg per week). This trial will use twice-daily dosing of lapatinib at a starting dose of 750 mg for 2 days (1500mg a day and 3000mg weekly dose), which is less than half of the continuous dose and has been shown to achieve plasma concentrations at 48 hours that are associated with synergy. Therefore, these findings can be translated into a novel, well-tolerated, and convenient combination regimen with significant potential for clinical activity. This trial will be a phase I dose-escalation study of lapatinib and paclitaxel for platinum-resistant ovarian cancer, which will establish the phase II dose for subsequent efficacy trials.
- Conditions
- Ovarian Cancer
- Being tested
- Lapatinib and Paclitaxel
- Keywords
- platinum-resistant
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lapatinib and PaclitaxelDrug
Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
| Study group | Role | What they receive |
|---|---|---|
| Lapatinib - Group 1 | Experimental | Patients in this group will receive Lapatinib (750mg PO BID) and Paclitaxel (80mg/m2). Receives: Drug: Lapatinib and Paclitaxel |
| Lapatinib - Group 2 | Experimental | Patients in this group will receive Lapatinib (1500mg PO BID) and Paclitaxel (80mg/m2). Receives: Drug: Lapatinib and Paclitaxel |
| Lapatinib - Group 3 | Experimental | Patients in this group will receive Lapatinib (2000mg PO BID) and Paclitaxel (80mg/m2). Receives: Drug: Lapatinib and Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival.
Number of patients with progression-free survival at one year.
Measured: One year
Number of Participants With Dose-limiting Toxicity
Dose limiting toxicity (DLT) is calculated as the total number of patients experiencing DLTs divided by the total number treated.
Measured: 4 weeks
Secondary outcomes (3)
Change in Plasma Concentration of Lapatinib Cycle 1
Plasma concentrations of lapatinib will be measured on days 8 and 15 prior to paclitaxel administration
Measured: 15 days (on day 8 and 15)
Change in Plasma Concentration of Lapatinib Cycle 2
Plasma concentrations of lapatinib will be measured on days 8 and 15 prior to paclitaxel administration
Measured: 15 days (on day 8 and 15)
Change in Plasma Concentration of Lapatinib Cycle 3
Plasma concentrations of lapatinib will be measured on days 8 and 15 prior to paclitaxel administration
Measured: 15 days (on day 8 and 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start17 Mar 2021
- Primary completion17 May 2024
- Study completion17 May 2024
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frederick R. Ueland, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Frederick R. Ueland, M.D., University of Kentucky
- Investigators
- Frederick Ueland, MD, Principal investigator, Markey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608409
- Sponsor's protocol ID
- MCC-20-GYN-06
- Other IDs
- 5P30CA177558-10
- Status last verified
- Jun 2025
- First submitted
- 22 Oct 2020
- Last updated
- 29 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cao CD, McCorkle JR, Yan D, Esfahani HS, Jayswal R, Piecoro D, Li N, Baldwin LA, Miller RW, Desimone CP, Dietrich CS, Ueland FR, Kolesar JM. A Phase 1 Dose Escalation of Lapatinib and Paclitaxel in Recurrent Ovarian Cancer. Cancers (Basel). 2026 Feb 14;18(4):626. doi: 10.3390/cancers18040626.
PubMed 41749879
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-Escalation Study on the Safety of Lapatinib With Dose-Dense Paclitaxel in Patients With Platinum-Resistant Ovarian Cancer
- ClinicalTrials.gov ID
- NCT04608409
- Acronym / sponsor ID
- MCC-20-GYN-06
- Conditions
- Ovarian Cancer
- Keywords
- platinum-resistant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Frederick R. Ueland, M.D.University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Posted 29 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will be a phase I dose-escalation study of lapatinib and paclitaxel for platinum-resistant ovarian cancer, which will establish the phase II dose for subsequent efficacy trials.
Detailed description
While ABCB1 (P-glycoprotein 1) upregulation after paclitaxel administration is well known, there is currently no clinically available method for preventing or overcoming it. To develop a therapy able to prevent ABCB1 upregulation and paclitaxel resistance, several ABCB1 inhibitors have been evaluated in combination with paclitaxel in preclinical model systems. Pulsed-dose lapatinib and paclitaxel are synergistic and inhibition of ABCB1 by lapatinib increases sensitivity to paclitaxel. Lapatinib is FDA approved, orally available, and previously studied in combination with weekly paclitaxel for breast cancer at doses of 1000mg to 1250mg daily (7000-8250mg per week). This trial will use twice-daily dosing of lapatinib at a starting dose of 750 mg for 2 days (1500mg a day and 3000mg weekly dose), which is less than half of the continuous dose and has been shown to achieve plasma concentrations at 48 hours that are associated with synergy. Therefore, these findings can be translated into a novel, well-tolerated, and convenient combination regimen with significant potential for clinical activity. This trial will be a phase I dose-escalation study of lapatinib and paclitaxel for platinum-resistant ovarian cancer, which will establish the phase II dose for subsequent efficacy trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lapatinib - Group 1 | Experimental | Drug: Lapatinib and PaclitaxelPatients in this group will receive Lapatinib (750mg PO BID) and Paclitaxel (80mg/m2). |
| Lapatinib - Group 2 | Experimental | Drug: Lapatinib and PaclitaxelPatients in this group will receive Lapatinib (1500mg PO BID) and Paclitaxel (80mg/m2). |
| Lapatinib - Group 3 | Experimental | Drug: Lapatinib and PaclitaxelPatients in this group will receive Lapatinib (2000mg PO BID) and Paclitaxel (80mg/m2). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- histologically or cytologically confirmed ovarian cancer who recur within 12 months of platinum-based chemotherapy
- ECOG performance status less than or equal to 2
- Adequate organ and marrow function at baseline
- ability to sign a written informed consent document
Key exclusion criteria (7 listed)
- hypersensitivity to lapatinib or paclitaxel
- uncontrolled intercurrent illness
- receiving medications that inhibit or induce CYP3A4
- malabsorption syndrome
- congestive heart failure
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 |
|---|---|---|
| Lapatinib and PaclitaxelParticipants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment. | Drug | Lapatinib - Group 1, Lapatinib - Group 2, Lapatinib - Group 3 |
Primary outcome
Progression-free Survival.
Time frame: One year
Number of patients with progression-free survival at one year.
Number of Participants With Dose-limiting Toxicity
Time frame: 4 weeks
Dose limiting toxicity (DLT) is calculated as the total number of patients experiencing DLTs divided by the total number treated.
3 secondary outcomes
Change in Plasma Concentration of Lapatinib Cycle 1
Time frame: 15 days (on day 8 and 15)
Change in Plasma Concentration of Lapatinib Cycle 2
Time frame: 15 days (on day 8 and 15)
Change in Plasma Concentration of Lapatinib Cycle 3
Time frame: 15 days (on day 8 and 15)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41749879Cao CD, McCorkle JR, Yan D, Esfahani HS, Jayswal R, Piecoro D, Li N, Baldwin LA, Miller RW, Desimone CP, Dietrich CS, Ueland FR, Kolesar JM. A Phase 1 Dose Escalation of Lapatinib and Paclitaxel in Recurrent Ovarian Cancer. Cancers (Basel). 2026 Feb 14;18(4):626. doi: 10.3390/cancers18040626.
- Individual participant dataSharing planned: No
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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.
Frederick Ueland, MD principal investigator
Markey Cancer Center
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 Lapatinib and Paclitaxel in people with Ovarian Cancer, run by Frederick R. Ueland, M.D. 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 4 inclusion and 7 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 29 Jun 2025. 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 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?
Yes. Results are posted in the registry (first posted 29 Jun 2025). 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?
Progression-free Survival. (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04608409, which also lists 1 linked publication.
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 29 Jun 2025.