NCT01633541

Concomitant Chemotherapy AND Bcl-xL Inhibitor (AT-101) For Bio-selection For Organ Preservation In Patients With Advanced Laryngeal Cancer

Completed Phase 2 Results posted Last updated 18 July 2023

What this trial tests

Phase 2 trial testing AT-101 in Laryngeal Cancer in 55 participants. Completed in 6 November 2021.

Timeline

1 March 2012

Primary endpoint
6 November 2021

6 November 2021

Quick facts

Lead sponsor	University of Michigan Rogel Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	55
Start date	1 March 2012
Primary completion	6 November 2021
Estimated completion	6 November 2021
Sites	1 location across United States

Drugs / interventions tested

• AT-101
• Docetaxel (Docetaxel) — full drug profile →
• Cisplatin (cisplatin) — full drug profile →
• Carboplatin (Carboplatin) — full drug profile →

Conditions studied

• Laryngeal Cancer — all drugs for Laryngeal Cancer →

Sponsor

University of Michigan Rogel Cancer Center

Who can join

18 and older, any sex, with Laryngeal Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Patients Alive and Free From Indication for Laryngectomy Three Months Post Treatment
  Time frame: Up to 3 months after end of treatment
  The primary clinical objective of this trial is to compare the larynx preservation rates in a treatment paradigm that uses induction chemotherapy plus AT-101 to select patients for either concurrent chemoradiation or surgery. Organ preservation rate, defined as alive and free from indication for laryngectomy three months post treatment, was chosen as the primary endpoint because it provides eviden
• Progression-free Survival
  Time frame: Up to 3 years after randomization
  Time from randomization to the time of first indication of local failure or metastases. Estimated non-parametrically using the Kaplan-Meier method.
• Overall Response Rate (ORR)
  Time frame: Up to approximately 60 days
  ORR (Complete Response \[CR\] plus Partial Response \[PR\]) to induction chemotherapy with platinum and docetaxel plus AT-101 following one and/or two cycles in patients with advanced laryngeal cancer.
• Percentage of Patients Experiencing Grade 3 or Higher Adverse Events.
  Time frame: Up to 3 years after end of treatment
  Toxicities will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE), version 3.

Sponsor's own description

To evaluate a new treatment approach for adults with advanced laryngeal cancer: induction chemotherapy with platinum and docetaxel plus AT-101. AT-101 is an investigational drug for the treatment of advanced cancer. It is hoped that the combination of this chemotherapy regimen will allow cancer patients to keep their voice box and to improve/maintain voice-related quality of life. The ultimate goal of this study is to prevent the surgery to remove subjects voice box.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Altered metabolism in cancer: insights into energy pathways and therapeutic targets.
   Tufail M, Jiang CH, Li N. · · 2024 · cited 265× · PMID 39294640 · DOI 10.1186/s12943-024-02119-3
2. Lactate in the Tumor Microenvironment: An Essential Molecule in Cancer Progression and Treatment.
   Pérez-Tomás R, Pérez-Guillén I. · · 2020 · cited 206× · PMID 33153193 · DOI 10.3390/cancers12113244
3. MCL-1 inhibition in cancer treatment.
   Xiang W, Yang CY, Bai L. · · 2018 · cited 105× · PMID 30425521 · DOI 10.2147/ott.s146228
4. Bcl-2 pathway inhibition in solid tumors: a review of clinical trials.
   Ploumaki I, Triantafyllou E, Koumprentziotis IA, Karampinos K, et al · · 2023 · cited 60× · PMID 36639602 · DOI 10.1007/s12094-022-03070-9
5. Changing the paradigm: the potential for targeted therapy in laryngeal squamous cell carcinoma.
   Ludwig ML, Birkeland AC, Hoesli R, Swiecicki P, et al · · 2016 · cited 26× · PMID 27144065 · DOI 10.28092/j.issn.2095-3941.2016.0010
6. The Tip of the Iceberg: Clinical Implications of Genomic Sequencing Projects in Head and Neck Cancer.
   Birkeland AC, Ludwig ML, Meraj TS, Brenner JC, et al · · 2015 · cited 18× · PMID 26506389 · DOI 10.3390/cancers7040879
7. Participation of MicroRNAs in the Treatment of Cancer with Phytochemicals.
   Son SW, Lee HY, Moeng S, Kuh HJ, et al · · 2020 · cited 15× · PMID 33066509 · DOI 10.3390/molecules25204701
8. Personalizing Medicine in Head and Neck Squamous Cell Carcinoma: The Rationale for Combination Therapies.
   Birkeland AC, Brenner JC. · · 2015 · cited 13× · PMID 26913293 · DOI 10.18103/mra.v0i3.77