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

NCT03078400 | Unknown Phase 1 FDA Drug

• 1 other identifier: SPL-006
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

Ovarian Epithelial Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events (Safety)

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

  Until dose-limiting toxicity, disease progression or 6 months

Secondary Outcomes (3)

• Response to Investigational Product

  Until dose-limiting toxicity, disease progression or 6 months

• Response to Investigational Product

  Until dose-limiting toxicity, disease progression or 6 months

• Response to Investigational Product

  Until dose-limiting toxicity, disease progression or 6 months

Study Arms (2)

Safety Phase

EXPERIMENTAL

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

Exploratory Expansion Phase

EXPERIMENTAL

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

Interventions

SPL-108 DRUG

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

Exploratory Expansion Phase; Safety Phase

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women with advanced ovarian epithelial cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Splash Pharmaceuticals, Inc.: lead

Study Sites (2)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 35750354 DERIVED

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• June Girda, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 4, 2017
• First Posted: March 13, 2017
• Study Start: March 10, 2017
• Primary Completion: January 31, 2020
• Study Completion: June 30, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)