AzTrials
AzTrials

Recurrent Ovarian CancerPhase 1NCT02195973

Phase IB Trial of LDE225 and Paclitaxel in Recurrent Ovarian Cancer

A Phase 1 study testing LDE225 in people with Recurrent Ovarian Cancer, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to find out if a new drug, LDE225, is safe and has beneficial effects when combined with paclitaxel in women with platinum resistant ovarian cancer. Platinum resistant ovarian cancer refers to recurrent ovarian cancer that has undergone chemotherapy inclusive of a platinum compound (e.g. Read more about this study

Who is it for?
Ages 19 years and older, women only
Conditions the study is for
Recurrent Ovarian Cancer
What is being tested?
LDE225
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
Sep 2014to 30 Sep 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 19 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma Histologic confirmation of the original primary tumor is required
  • Papillary serous, endometrioid, clear cell, undifferentiated and mixed histologies
  • Platinum resistant or refractory disease as per standard clinical and Gynecologic Oncology Group definition. Patients have had a treatment-free interval of less than 6 months from last platinum-based treatment to recurrence or progression during platinum based therapy
  • Patients must have received at least one-prior platinum based chemotherapy regimen, to include cisplatin, carboplatin or other organoplatinum compound, for treatment of primary or recurrent ovarian, fallopian tube or primary peritoneal cancer
  • Patients must have received a taxane as part of their prior treatment
  • Measurable disease is required. By definition, measurable disease is at least one lesion that can be accurately measured in at least one dimension with the longest dimension to be recorded. Each lesion must be ≥ 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, MRI or ≥ 10 mm when measured by spiral CT imaging
Show all 21Show fewer
  • Patients must have one target lesion to be utilized in order to assess response per RECIST criteria
  • ECOG Performance statuses of 0, 1, or 2
  • Adequate organ function as evidenced by:
  • Hematology: WBC ≥3.0 x 10^9/L; ANC ≥1.5 x 10^9/L; Platelets ≥100 x 10^9/L
  • Renal function: Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN) or 24-hour clearance greater than or equal to 50 mL/min
  • Hepatic function: Bilirubin ≤ 1.5 x ULN and ALT, SGOT and alkaline phosphatase ≤ 2.5 x ULN
  • Plasma creatine phosphatase (CK) less than 1.5 x ULN
  • Serum creatinine less than or equal to 1.5 x ULN or 24-hour clearance greater than or equal to 50 mL/min
  • Signed informed consent.
  • Female patients of any ethnic group. Female patients must be surgically sterile, postmenopausal (no menses for at least one year), or using medically approved method of contraception (excluding rhythm, withdraw or abstinence)
  • Age greater than or equal to 19
  • Recovery from effects of any recent surgery, chemotherapy and/or radiation
  • No evidence of active infection requiring antibiotic therapy
  • Hormonal therapy being utilized, as an anti-neoplastic treatment must be discontinued at least one week prior to study entry. Hormonal replacement therapy for symptom management is allowed
  • Any prior therapy directed at the malignancy including biologic or immunologic agents, must have be discontinued at least three weeks prior to study entry

Who cannot join

  • Patients with pathology demonstrating mucinous, carcinosarcoma or low malignant potential tumor histology are excluded. In addition, non-ovarian malignancies, malignant germ cell or stromal tumors are also excluded
  • Previous or concurrent malignancies at other sites within the last 5 years, with the exception of in situ carcinoma of the cervix and adequately treated basal cell carcinoma or squamous cell carcinoma of the skin. In addition, patients with prior or concomitant, based on hysterectomy, Stage IA endometrial adenocarcinoma with less than 3 mm depth on invasion, absence of lymphovascular space invasion and absence of grade 3, papillary serous or clear cell histology are allowed
  • Patients with prior radiation to the abdominal cavity or pelvis are excluded
  • Patients unable to take oral drugs or with lack of physical integrity of the upper gastrointestinal tract or known malabsorption syndromes
  • Patients who have previously been treated with systemic sonidegib (LDE225) or with other Hh pathway inhibitors
  • Serious concomitant illness including but not limited to: uncontrolled diabetes mellitus, dementia, active infection (including HIV infection) requiring IV or oral antibiotics and psychiatric illness and/or other uncontrolled medical conditions which may preclude compliance with study protocol
Show all 31Show fewer
  • Patients who have neuromuscular disorder (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis, such as HMG CoA inhibitors (statins), clofibrate and gemfibrozil, and the cannot be discontinued at least 2 weeks prior to starting sonidegib treatment. If it is essential that the patient remain on a statin to control hyperlididemia, only pravastatin may be used with extra caution
  • Patients who are planning on embarking on a new strenuous exercise regimen after initiation of study treatment. Muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided whilst on sonidegib treatment
  • Patients who have taken part in an experimental drug study within 4 weeks or 5 half-lives, whichever is longer, of initiating treatment with sonidegib
  • Patients who are receiving other anti-neoplastic therapy (e.g. chemotherapy, targeted therapy or radiotherapy) concurrently or within 2 weeks of starting treatment with sonidegib
  • Peripheral Neuropathy of NCI-CTC (National Cancer Institute-Common Toxicity Criteria) grade greater than or equal to 2
  • Impaired cardiac function or clinically significant heart disease, including any one of the following:
  • Angina pectoris within 3 months
  • Acute myocardial infarction within 3 months
  • QTcF > 470 msec on the screening ECG
  • A past medical history of clinically significant ECG abnormalities or a family history of prolonged QT-interval syndromes
  • Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5 mIU/mL)
  • Patients who are not willing to apply highly effective contraception during the study and through the duration as defined below after the final dose of study treatment
  • Women of childbearing potential defined as all women physiologically capable of becoming pregnant. Must use highly effective contraception during the study and through 20 months after the final dose of study treatment. Highly effective contraception is defined as either:
  • Total abstinence: When this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
  • Sterilization: Patient has had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman had been confirmed by follow- up hormone level assessment
  • Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female study patients, the vasectomized male partner should be the sole partner for that patient
  • Use a combination of the following (both a + b):
  • Placement of a non-hormonal intrauterine device (IUD) or non- hormonal intrauterine system (IUS)
  • Barrier method of contraception: Condom or occlusive cap (diaphragm or cervical vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
  • Note: Hormonal contraception methods (e.g. oral, injected, implanted) are not allowed as it cannot be ruled out that the study drug decreases the effectiveness of hormonal contraception.
  • Note: Women are considered post-menopausal and not child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels >40 mIU/mL and estradiol <20 pg/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six week ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
  • History of hypersensitivity to paclitaxel
  • Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
  • Patients who are receiving treatment with medications known to be moderate and strong inhibitors or inducers of CYP3A4/5 or drugs metabolized by CYP2B6 or CYP2C9 that have narrow therapeutic index, and that cannot be discontinued before starting treatment with sonidegib. Medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with sonidegib

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

Other trials in United States

About this study

Official title: Phase IB Trial of LDE225 and Weekly Paclitaxel in Recurrent Platinum Resistant Ovarian Cancer

The purpose of this study is to find out if a new drug, LDE225, is safe and has beneficial effects when combined with paclitaxel in women with platinum resistant ovarian cancer. Platinum resistant ovarian cancer refers to recurrent ovarian cancer that has undergone chemotherapy inclusive of a platinum compound (e.g. carboplatin or cisplatin).

Read the detailed description

Ovarian cancer remains the deadliest gynecologic cancer with a fairly low long-term cure rate. LDE225 is a new type of drug that inhibits or blocks a pathway responsible for cancer cell growth. LDE225 is an investigational drug that has been used either solely or in combination with chemotherapy in other types of cancer but not in ovarian cancer. Research evidence suggests that by combining LDE225 and paclitaxel together, ovarian cancer cells may become more responsive to treatment.

Being tested
LDE225
Keywords
ovarian cancer, platinum resistant, LED225, Sonidegib, Paclitaxel
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LDE225Drug

    Also called Sonidegib (LDE225), Taxol (Paclitaxel)

    After six cycles of weekly paclitaxel and LDE225, patients with a clinically beneficial response may be continued on weekly paclitaxel alone until disease progression.

Study groups in NCT02195973
Study groupRoleWhat they receive
Paclitaxel + LDE225ExperimentalPatients will receive intravenous paclitaxel on days 1, 8, and 15 every 28 days (3 weeks on followed by one week off). This constitutes one cycle. in addition to the paclitaxel oral LDE225 will be taken daily. Dosages of each drug will vary according to the study cohort and phase. The study consists of six cycles of treatment followed by clinic visits every 2-3 months for up to two years.
Receives: Drug: LDE225

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of weekly paclitaxel + LDE225 treatment

    Safety of weekly paclitaxel and LDE225 treatment in patients with recurrent, platinum-resistant ovarian adenocarcinoma will be monitored by physical exams, review of adverse events, and laboratory studies.

    Measured: up to 2 years

  2. Assessment of toxicities

    Assessment of toxicity will be performed using the National Cancer Institute Common Toxicity Criteria version 4.03.

    Measured: up to 2 years

Secondary outcomes (1)

  1. Optimal dose of LDE225 with paclitaxel

    The maximum tolerated dose and dose-limiting toxicities of weekly paclitaxel and daily LDE225 will be determined from laboratory tests on blood collected one to two times each cycle.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2014 (estimated)
  2. Study startSep 2014
  3. Primary completion10 Dec 2016
  4. Study completion30 Sep 2017

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02195973
Sponsor's protocol ID
F140214007 (UAB 1357)
Other IDs
000505867
Status last verified
Dec 2025
First submitted
17 Jul 2014
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LDE225 in people with Recurrent Ovarian Cancer, run by University of Alabama at Birmingham 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 31 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 9 Feb 2026. 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?

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?

Safety of weekly paclitaxel + LDE225 treatment (time frame: up to 2 years). 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 NCT02195973.

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 9 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in