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SC16LD6.5 in Recurrent Small Cell Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Stem CentRx, Inc.
Sponsor:
Information provided by (Responsible Party):
Stem CentRx, Inc.
ClinicalTrials.gov Identifier:
NCT01901653
First received: July 11, 2013
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to assess the safety and tolerability of SC16LD6.5 at different dose levels in patients with small cell lung cancer whose cancer has progressed or recurred following standard chemotherapy. Once a safe and tolerable dose is determined, the anti-cancer activity of SC16LD6.5 will be assessed by measuring the extent of tumor shrinkage. SC16LD6.5 is an antibody-drug conjugate (ADC). The antibody (SC16) targets a protein that appears to be expressed on the surface of most small cell lung cancers that have been assessed using an immunohistochemical assay. The drug, D6.5, is a very potent form of chemotherapy, specifically a DNA-damaging agent, that is cell cycle independent. ADC's theoretically provide more precise delivery of chemotherapy to cancer cells, possibly improving effectiveness relative to toxicities.


Condition Intervention Phase
Recurrent Small Cell Lung Cancer
Drug: SC16LD6.5
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Open Label Dose Escalation Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of SC16LD6.5 as a Single Agent in Patients With Recurrent Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Stem CentRx, Inc.:

Primary Outcome Measures:
  • Maximum Tolerated Dose [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • RECIST v1.1 Assessed Objective Response Rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics of SC16LD6.5 [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Standard PK variables, including Cmax, AUC, Vd, CL, and T1/2, will be assessed for SC16LD6.5, SC16, and D6.5

  • RECIST v1.1 Assessed Progression Free Survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: July 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SC16LD6.5
SC16LD6.5 will be administered as a single agent, at increasing dose levels as permitted based on real-time assessment of safety and tolerability, intravenously over 30 minutes. Doses will be repeated every 3 weeks until either unacceptable toxicity or evidence of disease progression occurs.
Drug: SC16LD6.5

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Provision of informed consent
  2. Male or female ≥18 years of age
  3. Histologic or cytologic confirmed diagnosis of small cell lung cancer, either limited or extensive disease at initial presentation is allowed
  4. Evidence of progressive disease during or following 1 or 2 prior chemotherapy regimens

    • At least 1 prior regimen must have contained a platinum salt
    • 'Adjuvant therapy' will constitute a prior treatment regimen
    • No more than 2 prior regimens are allowed
  5. Measurable disease (only for the phase II portion)
  6. ECOG Performance status 0-1
  7. A minimum life expectancy of 12 weeks
  8. Adequate bone marrow, hepatic and renal function as evidenced by:

    • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    • Platelet count ≥ 100 x 109/L
    • Hemoglobin ≥ 9.0 g/dL
    • Serum bilirubin < 1.5 x ULN
    • AST/ALT (SGOT/SGPT) < 2.5 x ULN for the reference laboratory or < 5 x ULN in the presence of liver metastases
    • Serum creatinine < 1.5 x ULN
  9. No 'active' CNS metastases. Prior CNS metastases are allowed, provided adequate palliative therapy has been administered and CNS disease control has been established prior to study entry.

    • A brain MRI scan, ≤ 28 days from day 1, is required

  10. Female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures and who have a negative serum pregnancy test within 1 week prior to initial study treatment. (See Appendix B)
  11. Male patients willing to use adequate contraceptive. (See Appendix B)
  12. At least 21 days must have elapsed prior to day 1 cycle 1, from chemotherapy, radiotherapy, immunotherapy or following major surgery and any surgical incision should be completely healed. At least 14 days must have elapsed prior to Day 1 Cycle 1 for "limited palliative radiotherapy", defined as a course of therapy encompassing < 25% total bone marrow volume and not exceeding 30 Gy.
  13. At least 14 days must have elapsed for chemotherapy regimens, biologic, and targeted therapy given continuously or on a weekly basis with limited potential for delayed toxicity.

Exclusion Criteria:

  1. Patients who are pregnant or breastfeeding.
  2. Active involvement of the Central Nervous System (CNS).
  3. Uncontrolled infection or systemic disease.
  4. Clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease e.g. angina, and cardiac arrhythmias) or myocardial infarction within the last 12 months.
  5. Chemotherapy regimens within the last 21 days (or within 6 weeks for prior nitrosourea or mitomycin C). Chemotherapy regimens, biologic, and targeted therapy given continuously or on a weekly basis with limited potential for delayed toxicity within the last 14 days.
  6. No concurrent systemic chemotherapy or anticancer biologic therapy is allowed. Note: Patients on hormonal treatment for breast cancer or prostate cancer may continue on treatment and enter into study.
  7. Known hypersensitivity to any components of SC16LD6.5 study drug product.
  8. Patients with known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both), a history of solid organ or bone marrow transplantation would generally be considered to have met exclusion criteria, however exceptions may be considered on a case-by-case basis by the medical monitor.
  9. Psychiatric disorder or social or geographic situation that would preclude study participation.
  10. QTcF interval of >450 msec (males) or >470 msec (females)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01901653

Contacts
Contact: Rejana Gore (615) 524-4410 Rejana.Gore@scri-innovations.com
Contact: Sara Ramsey (615) 329-7240 Sara.Ramsey@scri-innovations.com

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Liz Busby    205-934-0337    lizbusby@uab.edu   
Principal Investigator: Stefan Grant, MD, JD, MBBCh         
United States, Florida
Florida Cancer Specialists Recruiting
Sarasota, Florida, United States, 34232
Contact: Jill Martin       jimartin@flcancer.com   
Contact    941-377-9993 ext 319      
Principal Investigator: Manish Patel, MD         
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Clinical Trial Referral Line    855-702-8222      
Principal Investigator: Ravi Salgia, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Joanne Nicholls    646-888-4343    nichollj@mskcc.org   
Principal Investigator: Catherine Pietanza, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Debra Shoemaker    919-681-4768    debra.shoemaker@duke.edu   
Principal Investigator: Neal Ready, MD, PhD         
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact: Referral Line    615-339-4214    ASKSARAH@scresearch.net   
Principal Investigator: Howard ('Skip') Burris, MD         
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Lisa Foucheaux-Heider    713-792-2860    lmfoucheaux@mdanderson.org   
Principal Investigator: Bonnie Glisson, MD         
Sponsors and Collaborators
Stem CentRx, Inc.
Investigators
Study Director: Robert D Mass, MD Stem CentRx, Inc.
  More Information

No publications provided

Responsible Party: Stem CentRx, Inc.
ClinicalTrials.gov Identifier: NCT01901653     History of Changes
Other Study ID Numbers: SCRX16-001
Study First Received: July 11, 2013
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Stem CentRx, Inc.:
Small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014