A Phase 3 Study to Evaluate Marqibo® in the Treatment of Subjects ≥ 60 Years Old With Newly Diagnosed ALL
Study Details
Study Description
Brief Summary
A phase 3 study in the treatment of subjects >or= 60 years old with newly diagnosed acute lymphoblastic leukemia (ALL).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
A phase 3, multicenter, randomized study to evaluate the substitution of Marqibo® (Vincristine Sulfate Liposomes Injection, VSLI) for standard Vincristine Sulfate Injection (VSI) in the induction, intensification, and maintenance phases of combination chemotherapy in the treatment of subjects >or= 60 years old with newly diagnosed acute lymphoblastic leukemia (ALL).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vincristine Sulfate Injection (VSI) VSI dosed at 1.4 mg/m^2 with a 2 mg dose cap as an intravenous (IV) infusion over 10 minutes. |
Drug: Vincristine Sulfate Injection (VSI)
1.4 mg/m^2 with a 2 mg dose cap as an IV infusion over 10 minutes.
Other Names:
|
| Experimental: Marqibo Marqibo dosed at 2.25 mg/m^2 (without any dose cap) as an IV infusion over 60 minutes. |
Drug: Vincristine Sulfate Liposomes Injection (VSLI)
2.25 mg/m^2 (without any dose cap) as an IV infusion over 60 minutes.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Survival [36 months]
Overall survival was defined as the time from the date of study randomization until death from any cause. Observations censored at the date of the last follow-up for subjects not known to have died.
Eligibility Criteria
Criteria
Inclusion Criteria:
Have provided written, signed, and dated informed consent to participate in the study, in accordance with the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice (ICH GCP) Guideline E6 and all applicable local regulations. Are age >or=60 years (at the time of providing informed consent).
Have newly diagnosed, histologically proven, untreated Philadelphia chromosome-negative (Ph-) Acute lymphocytic leukemia [ALL], with >or= 5% bone marrow blasts.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Have a life expectancy >or= 3 months.
Have renal and liver function as defined below within 14 days, inclusive, prior to study enrollment, unless the abnormality is considered attributable to leukemia:
Total bilirubin ≤ 2.0 x the upper limit of normal (ULN), unless the subject has a known diagnosis of Gilbert's disease Aspartate transaminase (AST, Serum glutamic oxaloacetic transaminase [SGOT]) or alanine transaminase (ALT, Serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x ULN Serum creatinine ≤ 1.5 x ULN. Not have had major surgery within 4 weeks before the planned start of treatment.
If female, are post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (eg, hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) from the screening visit through 30 days after the last dose of any protocol defined chemotherapeutic agents.
If male and sexually active with a partner of child-bearing potential, agree to use an acceptable barrier method for contraception from the screening visit through 30 days after the last dose of any protocol defined chemotherapeutic agents.
Have the ability and willingness to fully comply with study procedures and restrictions.
-
Exclusion Criteria:
Has had prior systemic chemotherapy (for ALL or other malignancy). Has had prior vincristine for any reason. Is planning to undergo stem cell transplantation (SCT) as any part of first-line therapy for ALL.
Has Burkitt's lymphoma/leukemia. Has Philadelphia chromosome-positive (Ph+) ALL and/or BCR/ABL rearrangements documented by fluorescent in-situ hybridization (FISH), cytogenetics, or polymerase chain reaction (PCR).
Has active central nervous system (CNS) disease. Has ongoing neuropathy of any etiology > Grade 1. Has a history of persistent active neurologic disorders including demyelinating form of Charcot-Marie-Tooth syndrome, acquired demyelinating disorders, and other demyelinating conditions.
Prior hydroxyurea (Hydrea®) for the management of any condition other than leukocytosis or prior hydroxyurea of >7 days duration for the management of leukocytosis (hydroxyurea for the management of leukocytosis must be planned to be tapered off before or on Day 5 of Induction).
Has received prior steroids within 7 days before beginning protocol-specified Induction therapy for reasons other than leukocytosis (steroids for the management of leukocytosis are allowed but must be planned to be tapered off before or on Day 5 of Induction).
Has an active serious infection not controlled by oral or IV antibiotics or antifungals.
Has received any investigational therapy within 28 days before beginning any protocol-defined chemotherapeutic treatment.
-
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UC San Diego Moores Cancer Center | La Jolla | California | United States | 92093 |
| 2 | UCLA | Los Angeles | California | United States | 90095 |
| 3 | Emory University, Winship Cancer Institute | Atlanta | Georgia | United States | 30322 |
| 4 | Northwestern University Fienberg School of Medicine | Chicago | Illinois | United States | 60611 |
| 5 | University of Chicago | Chicago | Illinois | United States | 60637 |
| 6 | Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 7 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110-1093 |
| 8 | Nebraska Medical Center | Omaha | Nebraska | United States | 68198-7680 |
| 9 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 10 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 11 | Cornell | New York | New York | United States | 10021 |
| 12 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 13 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 14 | The University of Texas, M.D. Anderson Cancer Center | Houston | Texas | United States | 77030-4009 |
| 15 | Seattle Cancer Care Alliance | Seattle | Washington | United States | 98109 |
Sponsors and Collaborators
- Spectrum Pharmaceuticals, Inc
Investigators
- Principal Investigator: Susan M O'Brien, MD, MD Anderson
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TTX404
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Vincristine Sulfate Injection (VSI) | Marqibo |
|---|---|---|
| Arm/Group Description | VSI dosed at 1.4 mg/m^2 with a 2 mg dose cap as an intravenous (IV) infusion over 10 minutes. | Marqibo dosed at 2.25 mg/m^2 (without any dose cap) as an IV infusion over 60 minutes. |
| Period Title: Overall Study | ||
| STARTED | 13 | 13 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 13 | 13 |
Baseline Characteristics
| Arm/Group Title | Vincristine Sulfate Injection (VSI) | Marqibo | Total |
|---|---|---|---|
| Arm/Group Description | VSI dosed at 1.4 mg/m^2 with a 2 mg dose cap as an intravenous (IV) infusion over 10 minutes. | Marqibo dosed at 2.25 mg/m^2 (without any dose cap) as an IV infusion over 60 minutes. | Total of all reporting groups |
| Overall Participants | 13 | 13 | 26 |
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
67
|
67
|
67
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
6
46.2%
|
5
38.5%
|
11
42.3%
|
| Male |
7
53.8%
|
8
61.5%
|
15
57.7%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
7.7%
|
1
3.8%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
1
7.7%
|
1
3.8%
|
| White |
13
100%
|
11
84.6%
|
24
92.3%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Overall Survival |
|---|---|
| Description | Overall survival was defined as the time from the date of study randomization until death from any cause. Observations censored at the date of the last follow-up for subjects not known to have died. |
| Time Frame | 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data for this outcome measure was not collected due to early termination of study. |
| Arm/Group Title | Vincristine Sulfate Injection (VSI) | Marqibo |
|---|---|---|
| Arm/Group Description | VSI dosed at 1.4 mg/m^2 with a 2 mg dose cap as an intravenous (IV) infusion over 10 minutes. | Marqibo dosed at 2.25 mg/m^2 (without any dose cap) as an IV infusion over 60 minutes. |
| Measure Participants | 0 | 0 |
Adverse Events
| Time Frame | 2 years | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Vincristine Sulfate Injection (VSI) | Marqibo | ||
| Arm/Group Description | VSI dosed at 1.4 mg/m^2 with a 2 mg dose cap as an IV infusion over 10 minutes. | Marqibo dosed at 2.25 mg/m^2 (without any dose cap) as an IV infusion over 60 minutes. | ||
All Cause Mortality |
||||
| Vincristine Sulfate Injection (VSI) | Marqibo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/13 (76.9%) | 9/13 (69.2%) | ||
Serious Adverse Events |
||||
| Vincristine Sulfate Injection (VSI) | Marqibo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/13 (61.5%) | 12/13 (92.3%) | ||
| Blood and lymphatic system disorders | ||||
| Febrile Neutropenia | 4/13 (30.8%) | 4/13 (30.8%) | ||
| Neutropenia | 1/13 (7.7%) | 0/13 (0%) | ||
| Cardiac disorders | ||||
| Cardiac Arrest | 1/13 (7.7%) | 0/13 (0%) | ||
| Gastrointestinal disorders | ||||
| Constipation | 0/13 (0%) | 2/13 (15.4%) | ||
| Ileus | 0/13 (0%) | 1/13 (7.7%) | ||
| Rectal Haemorrhage | 0/13 (0%) | 1/13 (7.7%) | ||
| Diarrhoea | 1/13 (7.7%) | 0/13 (0%) | ||
| General disorders | ||||
| Pyrexia | 0/13 (0%) | 2/13 (15.4%) | ||
| Mucosal Inflammation | 0/13 (0%) | 1/13 (7.7%) | ||
| Systemic Inflammatory Response Syndrome | 0/13 (0%) | 1/13 (7.7%) | ||
| Asthenia | 1/13 (7.7%) | 0/13 (0%) | ||
| Hepatobiliary disorders | ||||
| Hepatic Failure | 1/13 (7.7%) | 2/13 (15.4%) | ||
| Hyperbilirubinaemia | 0/13 (0%) | 1/13 (7.7%) | ||
| Infections and infestations | ||||
| Sepsis | 4/13 (30.8%) | 1/13 (7.7%) | ||
| Pneumonia | 1/13 (7.7%) | 3/13 (23.1%) | ||
| Septic Shock | 2/13 (15.4%) | 2/13 (15.4%) | ||
| Bacteraemia | 0/13 (0%) | 2/13 (15.4%) | ||
| Aspergillus Infection | 1/13 (7.7%) | 0/13 (0%) | ||
| Cellulitis Orbital | 1/13 (7.7%) | 0/13 (0%) | ||
| Lung Infection | 1/13 (7.7%) | 0/13 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Subdural Haemorrhage | 1/13 (7.7%) | 1/13 (7.7%) | ||
| Femur Fracture | 0/13 (0%) | 1/13 (7.7%) | ||
| Fibula Fracture | 1/13 (7.7%) | 0/13 (0%) | ||
| Investigations | ||||
| Blood Bilirubin Increased | 2/13 (15.4%) | 0/13 (0%) | ||
| Transaminases Increased | 1/13 (7.7%) | 0/13 (0%) | ||
| Nervous system disorders | ||||
| Metabolic Encephalopathy | 0/13 (0%) | 1/13 (7.7%) | ||
| Dizziness | 1/13 (7.7%) | 0/13 (0%) | ||
| Presyncope | 1/13 (7.7%) | 0/13 (0%) | ||
| Psychiatric disorders | ||||
| Mental Status Changes | 1/13 (7.7%) | 1/13 (7.7%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Respiratory Failure | 0/13 (0%) | 2/13 (15.4%) | ||
| Bronchial Secretion Retention | 0/13 (0%) | 1/13 (7.7%) | ||
| Respiratory Distress | 0/13 (0%) | 1/13 (7.7%) | ||
| Acute Respiratory Failure | 1/13 (7.7%) | 0/13 (0%) | ||
| Pulmonary Embolism | 1/13 (7.7%) | 0/13 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Vincristine Sulfate Injection (VSI) | Marqibo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/13 (92.3%) | 13/13 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 9/13 (69.2%) | 6/13 (46.2%) | ||
| Febrile Neutropenia | 6/13 (46.2%) | 7/13 (53.8%) | ||
| Neutropenia | 4/13 (30.8%) | 6/13 (46.2%) | ||
| Thrombocytopenia | 7/13 (53.8%) | 9/13 (69.2%) | ||
| Coagulopathy | 0/13 (0%) | 3/13 (23.1%) | ||
| Cardiac disorders | ||||
| Atrial Fibrillation | 2/13 (15.4%) | 2/13 (15.4%) | ||
| Palpitations | 1/13 (7.7%) | 1/13 (7.7%) | ||
| Tachycardia | 1/13 (7.7%) | 2/13 (15.4%) | ||
| Eye disorders | ||||
| Vision Blurred | 0/13 (0%) | 2/13 (15.4%) | ||
| Gastrointestinal disorders | ||||
| Constipation | 10/13 (76.9%) | 9/13 (69.2%) | ||
| Diarrhoea | 9/13 (69.2%) | 5/13 (38.5%) | ||
| Nausea | 8/13 (61.5%) | 10/13 (76.9%) | ||
| Vomiting | 5/13 (38.5%) | 7/13 (53.8%) | ||
| Abdominal Pain | 4/13 (30.8%) | 3/13 (23.1%) | ||
| Dyspepsia | 0/13 (0%) | 4/13 (30.8%) | ||
| Flatulence | 1/13 (7.7%) | 2/13 (15.4%) | ||
| Abdominal Distension | 3/13 (23.1%) | 1/13 (7.7%) | ||
| Gastrooesophageal Reflux Disease | 1/13 (7.7%) | 1/13 (7.7%) | ||
| Oral Pain | 1/13 (7.7%) | 1/13 (7.7%) | ||
| Stomatitis | 1/13 (7.7%) | 1/13 (7.7%) | ||
| General disorders | ||||
| Asthenia | 4/13 (30.8%) | 7/13 (53.8%) | ||
| Fatigue | 7/13 (53.8%) | 3/13 (23.1%) | ||
| Oedema Peripheral | 3/13 (23.1%) | 9/13 (69.2%) | ||
| Mucosal Inflammation | 3/13 (23.1%) | 5/13 (38.5%) | ||
| Pyrexia | 3/13 (23.1%) | 3/13 (23.1%) | ||
| Chest Pain | 1/13 (7.7%) | 3/13 (23.1%) | ||
| Chills | 3/13 (23.1%) | 2/13 (15.4%) | ||
| Gait Disturbance | 0/13 (0%) | 2/13 (15.4%) | ||
| Malaise | 1/13 (7.7%) | 3/13 (23.1%) | ||
| Oedema | 2/13 (15.4%) | 3/13 (23.1%) | ||
| Chest Discomfort | 2/13 (15.4%) | 1/13 (7.7%) | ||
| Generalised Oedema | 2/13 (15.4%) | 1/13 (7.7%) | ||
| Pain | 3/13 (23.1%) | 1/13 (7.7%) | ||
| Hepatobiliary disorders | ||||
| Hyperbilirubinaemia | 6/13 (46.2%) | 6/13 (46.2%) | ||
| Infections and infestations | ||||
| Candida Infection | 0/13 (0%) | 2/13 (15.4%) | ||
| Cellulitis | 0/13 (0%) | 2/13 (15.4%) | ||
| Oral Candidiasis | 0/13 (0%) | 2/13 (15.4%) | ||
| Upper Respiratory Tract Infection | 0/13 (0%) | 2/13 (15.4%) | ||
| Bacteraemia | 3/13 (23.1%) | 1/13 (7.7%) | ||
| Pneumonia | 2/13 (15.4%) | 1/13 (7.7%) | ||
| Injury, poisoning and procedural complications | ||||
| Contusion | 2/13 (15.4%) | 1/13 (7.7%) | ||
| Procedural Pain | 1/13 (7.7%) | 1/13 (7.7%) | ||
| Investigations | ||||
| Alanine Aminotransferase Increased | 5/13 (38.5%) | 7/13 (53.8%) | ||
| Aspartate Aminotransferase Increased | 5/13 (38.5%) | 7/13 (53.8%) | ||
| Blood Alkaline Phosphatase Increased | 5/13 (38.5%) | 5/13 (38.5%) | ||
| Blood Bilirubin Increased | 3/13 (23.1%) | 7/13 (53.8%) | ||
| Lipase Increased | 4/13 (30.8%) | 4/13 (30.8%) | ||
| Blood Creatinine Increased | 0/13 (0%) | 5/13 (38.5%) | ||
| Transaminases Increased | 1/13 (7.7%) | 3/13 (23.1%) | ||
| White Blood Cell Count Decreased | 2/13 (15.4%) | 3/13 (23.1%) | ||
| Blood Phosphorus Increased | 3/13 (23.1%) | 1/13 (7.7%) | ||
| Weight Decreased | 2/13 (15.4%) | 1/13 (7.7%) | ||
| Alkaline Phosphatase Increased | 0/13 (0%) | 2/13 (15.4%) | ||
| Amylase Increased | 3/13 (23.1%) | 1/13 (7.7%) | ||
| Blood Fibrinogen Decreased | 0/13 (0%) | 2/13 (15.4%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased Appetite | 4/13 (30.8%) | 6/13 (46.2%) | ||
| Hyperglycaemia | 5/13 (38.5%) | 5/13 (38.5%) | ||
| Hypocalcaemia | 5/13 (38.5%) | 7/13 (53.8%) | ||
| Hypokalelmia | 6/13 (46.2%) | 9/13 (69.2%) | ||
| Hyponatraemia | 5/13 (38.5%) | 8/13 (61.5%) | ||
| Hypophosphataemia | 6/13 (46.2%) | 6/13 (46.2%) | ||
| Hypoalbuminaemia | 4/13 (30.8%) | 4/13 (30.8%) | ||
| Hypomagnesaemia | 4/13 (30.8%) | 5/13 (38.5%) | ||
| Acidosis | 2/13 (15.4%) | 1/13 (7.7%) | ||
| Fluid Overload | 0/13 (0%) | 2/13 (15.4%) | ||
| Hypermagnesaemia | 1/13 (7.7%) | 2/13 (15.4%) | ||
| Hypernatraemia | 1/13 (7.7%) | 1/13 (7.7%) | ||
| Metabolic Acidosis | 0/13 (0%) | 2/13 (15.4%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 4/13 (30.8%) | 2/13 (15.4%) | ||
| Pain In Extremity | 3/13 (23.1%) | 4/13 (30.8%) | ||
| Back Pain | 2/13 (15.4%) | 3/13 (23.1%) | ||
| Muscular Weakness | 2/13 (15.4%) | 2/13 (15.4%) | ||
| Neck Pain | 0/13 (0%) | 2/13 (15.4%) | ||
| Nervous system disorders | ||||
| Headache | 6/13 (46.2%) | 5/13 (38.5%) | ||
| Dizziness | 3/13 (23.1%) | 6/13 (46.2%) | ||
| Neuropathy Peripheral | 4/13 (30.8%) | 4/13 (30.8%) | ||
| Paraesthesia | 4/13 (30.8%) | 2/13 (15.4%) | ||
| Dysgeusia | 2/13 (15.4%) | 2/13 (15.4%) | ||
| Hypoaesthesia | 3/13 (23.1%) | 1/13 (7.7%) | ||
| Neuralgia | 0/13 (0%) | 2/13 (15.4%) | ||
| Neuropathy | 0/13 (0%) | 3/13 (23.1%) | ||
| Syncope | 2/13 (15.4%) | 1/13 (7.7%) | ||
| Hepatic Encephalopathy | 1/13 (7.7%) | 1/13 (7.7%) | ||
| Lethargy | 1/13 (7.7%) | 1/13 (7.7%) | ||
| Psychiatric disorders | ||||
| Anxiety | 5/13 (38.5%) | 5/13 (38.5%) | ||
| Insomnia | 4/13 (30.8%) | 6/13 (46.2%) | ||
| Confusional State | 2/13 (15.4%) | 4/13 (30.8%) | ||
| Depression | 2/13 (15.4%) | 2/13 (15.4%) | ||
| Mental Status Changes | 2/13 (15.4%) | 3/13 (23.1%) | ||
| Agitation | 1/13 (7.7%) | 1/13 (7.7%) | ||
| Renal and urinary disorders | ||||
| Renal Injury | 1/13 (7.7%) | 5/13 (38.5%) | ||
| Dysuria | 3/13 (23.1%) | 1/13 (7.7%) | ||
| Urinary Incontinence | 1/13 (7.7%) | 1/13 (7.7%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Epistaxis | 3/13 (23.1%) | 4/13 (30.8%) | ||
| Nasal Congestion | 3/13 (23.1%) | 3/13 (23.1%) | ||
| Cough | 3/13 (23.1%) | 2/13 (15.4%) | ||
| Pleural Effusion | 1/13 (7.7%) | 2/13 (15.4%) | ||
| Respiratory Alkalosis | 1/13 (7.7%) | 2/13 (15.4%) | ||
| Tachypnoea | 1/13 (7.7%) | 3/13 (23.1%) | ||
| Dyspnoea | 4/13 (30.8%) | 1/13 (7.7%) | ||
| Hypoxia | 1/13 (7.7%) | 1/13 (7.7%) | ||
| Oropharyngeal Pain | 2/13 (15.4%) | 1/13 (7.7%) | ||
| Wheezing | 2/13 (15.4%) | 1/13 (7.7%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Rash | 2/13 (15.4%) | 5/13 (38.5%) | ||
| Pruritus | 0/13 (0%) | 3/13 (23.1%) | ||
| Rash Generalised | 0/13 (0%) | 2/13 (15.4%) | ||
| Erythema | 2/13 (15.4%) | 1/13 (7.7%) | ||
| Hyperhidrosis | 1/13 (7.7%) | 1/13 (7.7%) | ||
| Vascular disorders | ||||
| Hypotension | 5/13 (38.5%) | 7/13 (53.8%) | ||
| Deep Vein Thrombosis | 0/13 (0%) | 2/13 (15.4%) | ||
| Hypertension | 0/13 (0%) | 2/13 (15.4%) | ||
| Orthostatic Hypotension | 2/13 (15.4%) | 2/13 (15.4%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Gajanan Bhat, PhD |
|---|---|
| Organization | Spectrum Pharmaceuticals |
| Phone | 949-743-9219 |
| Gajanan.Bhat@appirx.com |
- TTX404