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Ovarian Epithelial CancerPhase 1NCT03078400

Safety and Efficacy Study of Daily SPL-108 Injections In Conjunction With Paclitaxel in Women With Ovarian Cancer

A Phase 1 study testing SPL-108 in people with Ovarian Epithelial Cancer, run by Splash Pharmaceuticals, Inc. at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Up to 18 women with ovarian cancer will administer up to two injections of SPL-108 daily in combination with weekly doses of Paclitaxel. They will be monitored for safety and efficacy for up to 6 months, until disease progression or unacceptable toxicity. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Epithelial Cancer
What is being tested?
SPL-108
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
2 sitesUnited States
Study dates
10 Mar 2017to 30 Jun 2020
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

  • Females ≥18 years of age
  • Platinum-resistant recurrent or metastatic epithelial ovarian carcinoma
  • Positivity on CD44 assay as defined by strong (+++) or moderate (++) staining in 20% or more of the tumor tissue/stroma as obtained by biopsy or paracentesis
  • Status post first-line therapy with definitive surgery (which provided tissue for pathologic diagnosis) and chemotherapy
  • Original diagnosis has been confirmed through a histopathologic review of the primary tumor slides by an expert pathologist at the Principal Investigator's institution
  • Disease has progressed or recurred during or less than 6 months after platinum-based chemotherapy at some point during the subject's course.
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  • No more than 3 prior regimens of cytotoxic chemotherapy unless approved by the sponsor (Note: all platinum-containing regimens are not to be counted separately but are considered to be a single regimen for the purposes of this criterion)
  • Measurable disease by RECIST 1.1 criteria
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1, or 2
  • Women with childbearing potential and partners must both use effective contraception during the study and for 3 months after the last dose
  • Life expectancy of at least 6 months
  • Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before the first study-specific procedure

Who cannot join

  • Treatment with cytotoxic chemotherapy for malignancies other than ovarian cancer within the past 5 years
  • Fewer than 28 days before Cycle 1 Day 1 since any prior chemotherapy (less than 42 days in the case of mitomycin or a nitrosourea)
  • Fewer than 28 days before Cycle 1 Day 1 since administration of hormonal or biological anti-neoplastic agents
  • Concomitant use of other cytotoxic or cytostatic drugs other than PTX
  • Abnormal clinical laboratory values within 14 days prior to initiation of dosing, as indicated by:
  • Hemoglobin level <9.0 gm/L
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  • Platelet count <100,000/mm3
  • Granulocyte count <1500/mm3
  • Serum creatinine level ≥2.5 mg/dL (221 μmol/L)
  • Liver aminotransferase levels greater than 3 times the laboratory's upper limit of normal (greater than 5 times the laboratory's upper limit of normal if the liver is known to be involved with tumor)
  • Contraindication to the use of PTX
  • Pregnancy or breast-feeding at time of Screening and throughout the study.
  • Active, uncontrolled infection
  • Participation in another investigational drug trial concurrently or within 30 days of Cycle 1 Day 1, or a vaccine trial within 90 days of Cycle 1 Day 1
  • Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subject's ability to complete the trial, and/or compromise the objectives of the trial

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Columbia University Medical Center

    New York, New York, 10032

Other trials in United States

About this study

Official title: An Open-label Phase 1 Trial of the Safety and Efficacy of Daily Subcutaneous SPL-108 Injections When Used In Combination With Paclitaxel In Patients With Platinum-resistant, CD44+, Advanced Ovarian Epithelial Cancer

Up to 18 women with ovarian cancer will administer up to two injections of SPL-108 daily in combination with weekly doses of Paclitaxel. They will be monitored for safety and efficacy for up to 6 months, until disease progression or unacceptable toxicity.

Read the detailed description

This is an open-label 2-arm trial. Eligible subjects will be screened and enrolled sequentially into 1 of 2 Arms:

Arm I: N=6 to 12 subjects, Safety Phase

  • Cohort 1 SPL-108 x 1 injection daily + 80 mg/m2 PTX weekly on Days 1, 8, and 15 in 28 day cycles
  • Cohort 2 SPL-108 BID + 80 mg/m2 PTX weekly on Days 1, 8, and 15 in 28 day cycles

For Arm I, at least 1 week will elapse between Dose 1 for each subject.

In Cohort 1, 3 subjects will be enrolled: if 1 dose-limiting toxicity (DLT) occurs, 3 subjects will be added at this dose level; if 0/3 or 1/6 DLTs occur, Cohort 2 will initiate enrolling subjects; if 2 or more DLTs occur at this dose level, subjects will not be enrolled in Cohort 2 and the trial will be terminated.

In Cohort 2, 3 subjects will be enrolled: if 1 DLT occurs, 3 subjects will be added at this dose level; if 0/3 or 1/6 DLTs occur, Arm II will initiate enrolling subjects at the SPL-108 BID dose; if 2 or more DLTs occur, Arm II will initiate enrolling subjects at the SPL-108 dose one time each day.

Arm II: N=up to 12, Exploratory Expansion Phase

  • Cohort 3: SPL-108 daily dose (to be determined in Arm I) + 80 mg/m2 PTX weekly on Days 1, 8, and 15 in 28 day cycles.

A Safety Committee will meet at the end of each Arm I Cohort as well as periodically to review safety data and make recommendations for trial progression. The primary efficacy outcome, Response Evaluation Criteria in Solid Tumors Committee (RECIST 1.1) criteria, will be assessed on Day 15 of Cycles 2, 4, and 6.

Being tested
SPL-108
Medical subject headings
Carcinoma, Ovarian Epithelial

What participants receive

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

  • SPL-108Drug

    Subcutaneous injection of 150 mg administered either one time or two times per day.

Study groups in NCT03078400
Study groupRoleWhat they receive
Safety PhaseExperimentalSix to 12 subjects * Cohort 1 SPL-108 injection daily + 80 mg/m2 PTX weekly on Days 1, 8, and 15 in 28 day cycles * Cohort 2 SPL-108 BID injection + 80 mg/m2 PTX weekly on Days 1, 8, and 15 in 28 day cycles
Receives: Drug: SPL-108
Exploratory Expansion PhaseExperimentalUp to 12 subjects • Cohort 3: SPL-108 daily dose (to be determined in Arm I) + 80 mg/m2 PTX weekly on Days 1, 8, and 15 in 28 day cycles.
Receives: Drug: SPL-108

What is being measured

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

  1. Incidence of Adverse Events (Safety)

    Includes adverse events, laboratory data, physical examination findings, vital signs, weight and ECOG Performance Status

    Measured: Until dose-limiting toxicity, disease progression or 6 months

Secondary outcomes (3)

  1. Response to Investigational Product

    Objective response (OR) through imaging assessments

    Measured: Until dose-limiting toxicity, disease progression or 6 months

  2. Response to Investigational Product

    Objective response (OR) through changes in CA 125 levels

    Measured: Until dose-limiting toxicity, disease progression or 6 months

  3. Response to Investigational Product

    Objective response (OR) as assessed through changes in Quality of Life (FACT-O Questionnaire)

    Measured: Until dose-limiting toxicity, disease progression or 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 posted13 Mar 2017
  2. Study start10 Mar 2017
  3. Primary completion31 Jan 2020
  4. Study completion30 Jun 2020 (estimated)

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
Non-randomised
Intervention model
Sequential
Model description
Arm I: N=6 to 12, Safety Phase, 3 + 3 design with 2 cohorts. * Cohort 1 SPL-108 150 mg daily + 80 mg/m2 PTX weekly on Days 1, 8, and 15 in 28 day cycles * Cohort 2 SPL-108 300 mg daily (150 mg q12 hours) + 80 mg/m2 PTX weekly on Days 1, 8, and 15 in 28 day cycles Arm II: N=up to 12, Exploratory Expansion Phase • Cohort 3: SPL-108 daily dose (to be determined in Arm I) + 80 mg/m2 PTX weekly on Days 1, 8, and 15 in 28 day cycles.
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03078400
Sponsor's protocol ID
SPL-006
Status last verified
Mar 2020
First submitted
4 Mar 2017
Last updated
18 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Girda E, Hou J, Nelson D, Finlayson M, de Meritens AB, Chekmareiva M, Leiser A, Song M, Stephenson R, Chan N, Tergas AI, Vattakalam R, Wright JD, Yu H, Martincuks A, Kohut A, Palmer J, Rodriguez-Rodriguez L. Phase I trial of daily subcutaneous SPL-108 injections in combination with paclitaxel in patients with platinum resistant CD44+ advanced ovarian epithelial cancer. Int J Gynecol Cancer. 2022 Aug 1;32(8):1032-1038. doi: 10.1136/ijgc-2021-003316.

    PubMed 35750354

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SPL-108 in people with Ovarian Epithelial Cancer, run by Splash Pharmaceuticals, Inc. at 2 sites 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 12 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Results are not available in the source record.

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?

Incidence of Adverse Events (Safety) (time frame: Until dose-limiting toxicity, disease progression or 6 months). 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 NCT03078400, 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 18 Mar 2020.

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