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

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ClinicalTrials.gov Identifier: NCT03078400
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Splash Pharmaceuticals, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Ovarian Epithelial Cancer Drug: SPL-108 Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : March 10, 2017
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : December 31, 2018


Arm Intervention/treatment
Experimental: Safety Phase

Six 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
Drug: SPL-108
Subcutaneous injection of 150 mg administered either one time or two times per day.

Experimental: Exploratory Expansion Phase

Up 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.

Drug: SPL-108
Subcutaneous injection of 150 mg administered either one time or two times per day.




Primary Outcome Measures :
  1. Incidence of Adverse Events (Safety) [ Time Frame: Until dose-limiting toxicity, disease progression or 6 months ]
    Includes adverse events, laboratory data, physical examination findings, vital signs, weight and ECOG Performance Status


Secondary Outcome Measures :
  1. Response to Investigational Product [ Time Frame: Until dose-limiting toxicity, disease progression or 6 months ]
    Objective response (OR) through imaging assessments

  2. Response to Investigational Product [ Time Frame: Until dose-limiting toxicity, disease progression or 6 months ]
    Objective response (OR) through changes in CA 125 levels

  3. Response to Investigational Product [ Time Frame: Until dose-limiting toxicity, disease progression or 6 months ]
    Objective response (OR) as assessed through changes in Quality of Life (FACT-O Questionnaire)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women with advanced ovarian epithelial cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Females ≥18 years of age
  2. Platinum-resistant recurrent or metastatic epithelial ovarian carcinoma
  3. 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
  4. Status post first-line therapy with definitive surgery (which provided tissue for pathologic diagnosis) and chemotherapy
  5. Original diagnosis has been confirmed through a histopathologic review of the primary tumor slides by an expert pathologist at the Principal Investigator's institution
  6. Disease has progressed or recurred during or less than 6 months after platinum-based chemotherapy at some point during the subject's course.
  7. 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)
  8. Measurable disease by RECIST 1.1 criteria
  9. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1, or 2
  10. Women with childbearing potential and partners must both use effective contraception during the study and for 3 months after the last dose
  11. Life expectancy of at least 6 months
  12. 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

Exclusion Criteria:

  1. Treatment with cytotoxic chemotherapy for malignancies other than ovarian cancer within the past 5 years
  2. 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)
  3. Fewer than 28 days before Cycle 1 Day 1 since administration of hormonal or biological anti-neoplastic agents
  4. Concomitant use of other cytotoxic or cytostatic drugs other than PTX
  5. Abnormal clinical laboratory values within 14 days prior to initiation of dosing, as indicated by:

    • Hemoglobin level <9.0 gm/L
    • 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)
  6. Contraindication to the use of PTX
  7. Pregnancy or breast-feeding at time of Screening and throughout the study.
  8. Active, uncontrolled infection
  9. 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
  10. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078400


Contacts
Contact: Demmie Aguilar 732-235-8780 da572@cinj.rutgers.edu

Locations
United States, New Jersey
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Principal Investigator: Lorna Rodriguez, MD         
United States, New York
Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
Contact: Reena Vattakalam    212-342-6895    rmv2110@cumc.columbia.edu   
Principal Investigator: June Y Hou, MD         
Sponsors and Collaborators
Splash Pharmaceuticals, Inc.
Investigators
Principal Investigator: Lorna Rodriguez, MD Rutgers Cancer Institute of New Jersey

Responsible Party: Splash Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03078400     History of Changes
Other Study ID Numbers: SPL-006
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action