Dose Escalation Safety Study of TL32711 in Adults With Refractory Solid Tumors or Lymphoma

NCT00993239 | Completed Phase 1

• 1 other identifier: TL32711-FIH-007-PTL-F
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

A Phase 1 open-label, non-randomized dose escalation study to determine the maximum tolerated dose (MTD) and characterize the safety and tolerability of Birinapant (TL32711).

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Define the MTD

  4 weeks (Cycle 1)

Secondary Outcomes (2)

• Tumor burden according to Response Evaluation Criteria in Solid Tumors (RECIST)/Revised Response Criteria Malignant Lymphoma

  Every 8 weeks (2 cycles) while on treatment

• Translational biomarkers and pharmacokinetics

  First and third dose of Cycle 1 and after every two cycles (biomarkers only) while on treatment

Study Arms (1)

Birinapant (TL32711)

EXPERIMENTAL

Drug: Birinapant (TL32711)

Interventions

Birinapant (TL32711) DRUG

30 minute intravenous (IV) infusion administered once weekly for three consecutive weeks followed by a one week off (Cycle) repeated every 4 weeks as tolerated

Also known as: NSC 756502

Birinapant (TL32711)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced metastatic or unresectable malignancy that is refractory to currently available standard therapies or no effective therapy exists. The subject's malignancy must be confirmed by prior pathologic study.
• Evaluable disease (measurable or non-measurable) by Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1) or Revised Response Criteria for Malignant Lymphoma (RRCML) (Cheson 2007).
• Life expectancy greater than 3 months.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
• Adequate renal function, defined as serum creatinine ≤ 1.5 X upper limit of normal (ULN), or calculated creatinine clearance ≥ 60 ml/min.
• Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 3 X ULN and total bilirubin \< 1.5 X ULN.
• Adequate bone marrow function, defined as absolute neutrophil (ANC) ≥ 1,500/mm3 (≥1.5 X106/L), platelet count ≥ 75,000/mm3 (≥ 75 X106/L), and hemoglobin ≥ 10 mg/dL in the absence of transfusion.

You may not qualify if:

• Recent anti-cancer treatment defined as:
• Standard or investigational anti-cancer therapy within 4 weeks prior to first dose of TL32711. Exception: continued hormonal interventions for sensitive diseases.
• Radiation therapy within 2 weeks prior to the first dose of TL32711.
• Clinically significant pulmonary illness resulting in Grade ≥ 2 hypoxia (National Cancer Institute Common Terminology criteria for Adverse Events \[NCI CTCAE, v4\]) or any requirement for supplemental oxygen, or pulse oximetry less than 90% saturation on room air.
• Symptomatic or uncontrolled brain metastases requiring current treatment (less than 4 weeks from last cranial radiation or 2 weeks from last steroids).
• Impaired cardiac function or clinically significant cardiac disease.
• Ongoing auto-immune disease or with history of an auto-immune disease within the past 5 years. Auto-immune disease include but are not limited to systemic lupus erythematosis, scleroderma, rheumatoid arthritis, psoriasis, psoriatic arthritis, ulcerative colitis and regional enteritis (Crohn's disease).
• Systemic or chronic topical corticosteroids or immunosuppressive therapy within 4 weeks prior to study entry or anticipated need of systemic corticosteroids or immunosuppressive therapy during study participation.
• Skin lesions of Grade ≥ 2 severity (NCI CTCAE v4), except alopecia.
• Lack of recovery of prior adverse events to Grade ≤1 severity (NCI CTCAE v 4) (except alopecia or neuropathy) due to medications administered prior to the first dose of TL32711.

Sponsors & Collaborators

• TetraLogic Pharmaceuticals: lead

Study Sites (3)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

birinapant

Study Officials

• Ravi Amaravadi, MD

  University of Pennsylvania, Abramson Cancer Center

  PRINCIPAL INVESTIGATOR

• Lainie P Martin, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

• Alex Adjei, MD, PhD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2009
• First Posted: October 12, 2009
• Study Start: November 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: March 1, 2013
• Last Updated: March 3, 2016

Record last verified: 2016-03

Locations

US (3)