Study to Evaluate GSK3052230 in Combination With Paclitaxel and Carboplatin, or Docetaxel or as Single Agent in Subjects With Solid Malignancies and Deregulated Fibroblast Growth Factor (FGF) Pathway Signaling

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01868022
First received: May 30, 2013
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

This phase IB trial aims to identify anticancer activity of GSK3052230 in subjects with malignancies with abnormal dependence on FGF pathway signaling. Combination doses of GSK3052230 with standard of care chemotherapy in the first and second line setting of metastatic squamous non-small cell lung cancer (NSCLC) will be identified in the 3+3 dose-escalation design of the study. This will be a multi-arm, multicenter, non-randomized, parallel-group, uncontrolled, open-label Phase IB study designed to evaluate the safety, tolerability and preliminary activity of GSK3052230 in combination with paclitaxel + carboplatin (Arm A), in combination with docetaxel (Arm B), or in combination with pemetrexed + cisplatin (Arm C). Approximately 70 subjects will be enrolled in the study (approximately up to 120 may be enrolled).


Condition Intervention Phase
Cancer
Drug: GSK3052230
Drug: paclitaxel
Drug: carboplatin
Drug: docetaxel
Drug: pemetrexed
Drug: cisplatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-arm, Non-randomized, Open-Label Phase IB Study to Evaluate GSK3052230 in Combination With Paclitaxel and Carboplatin, or Docetaxel or as Single Agent in Subjects With Solid Malignancies and Deregulated FGF Pathway Signaling

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Rate and severity of adverse events (AEs) as a measure of safety and tolerability [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    AEs will be collected from the time the first dose of study treatment is administered until 30 days following discontinuation of study treatment regardless of initiation of a new cancer therapy or transfer to hospice. Severity of AEs will be graded utilizing the National Cancer Institute- Common Terminology Criteria for AEs (NCI-CTCAE) version 4.03

  • Number of Participants withdrawn due to AEs as measure of safety and tolerability [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Dose interruptions and reduction as a measure of safety and tolerability [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Treatment duration as a measure of safety and tolerability [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Dose limiting toxicity (DLT) as a measure of safety and tolerability [ Time Frame: Cycle 1 (first 21 days of study treatment). ] [ Designated as safety issue: No ]
    DLT: Toxicity due to GSK3052230 its combination with chemotherapy within Cycle 1 that are unlikely to be due to another cause ( known effects of cytotoxic chemotherapy, disease progression, or accident according to the following criteria: Grade 3 or 4 clinically significant non-hematological toxicity, Grade 4 neutropenia lasting more than 7 days, Grade 4 febrile Neutropenia, Grade 4 thrombocytopenia, Grade 4 clinically significant lab abnormalities with duration greater than 48hrs, Treatment delay of 14 days or greater due to unresolved drug-related toxicity, and any grade 2 toxicity

  • Change from baseline in vital sign as a measure of safety and tolerability [ Time Frame: Baseline and Day 1 of each treatment cycle (Up to 6 months). ] [ Designated as safety issue: No ]
    Vital signs include: systolic blood pressure, diastolic blood pressure, temperature, respiration rate and pulse rate. Vital signs will be measured after subject resting for at least 5 minutes in a semi-supine position.

  • Change from baseline in 12-lead electrocardiogram (ECG) as a measure of safety and tolerability [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    12-lead ECGs will be obtained at designated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals.

  • Change from baseline in Echocardiogram (ECHO) as measure of safety and tolerability [ Time Frame: Baseline and Cycle 4 (Day 60). ] [ Designated as safety issue: No ]
    ECHOs will be performed at baseline to assess cardiac ejection fraction and cardiac valve morphology for the purpose of study eligibility and Cycle 4. Evaluation of ECHO will include evaluation for left ventricular ejection fraction (LVEF) and both right and left-sided valvular lesions.

  • Change from baseline in laboratory test as measure of safety and tolerability [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
    Laboratory parameters include: hematology, urinalysis, clinical chemistry and additional parameters

  • Maximum tolerated dose (MTD) or maximum feasible dose (MFD) of GSK3052230 in arm A and B [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    The MTD for the combination regimens in Arm A and B will be defined as the highest dose level tested at which < 33% of subjects experience a DLT.

  • Best response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Best response defined as complete or partial response, stable disease or progressive disease according to RECIST 1.1

  • Overall response rate (ORR) per RECIST 1.1 or modified RECIST [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    ORR defined as the proportion of subjects with investigator-assessed confirmed complete response or partial response per RECIST 1.1 or modified RECIST for Malignant pleural mesothelioma (MPM)

  • Change from baseline in physical examination parameters. [ Time Frame: Baseline and Up to follow up visit (7 months). ] [ Designated as safety issue: No ]
    Physical examinations include will include assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities. Height and weight will also be measured and recorded


Secondary Outcome Measures:
  • Progression-free survival (PFS) by investigator assessment per RECIST 1.1 or modified RECIST [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    PFS is defined as the interval between first dose of GSK3052230 and the earliest date of disease progression or death due to any cause by investigator assessment per RECIST 1.1 or modified RECIST for MPM

  • GSK3052230 population pharmacokinetic (PK) profile [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    GSK3052230 population PK parameters include: systemic clearance of parent drug (CL) and apparent volume of distribution after IV administration (Vd), and relevant covariates which may influence exposure (e.g. age, weight, or disease related covariates)

  • Change from baseline in Forced Vital Capacity (FVC) in subjects with MPM [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    FVC will be measured to to assess improvement in pulmonary function in subject with MPM in arm C only


Estimated Enrollment: 104
Study Start Date: October 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: GSK3052230 + paclitaxel/carboplatin
Subject will receive GSK3052230 as 30-minute intravenous (i.v.) infusion once a week (Day 1, Day 8, Day 15) of each 21-day cycle + paclitaxel (constant infusion for 3 hrs) and carboplatin (constant infusion for 30 to 60 minutes) iv on Day 1 of each 21-day cycle. The number of cycles of paclitaxel/carboplatin will be limited to 4 to 6 cycles.
Drug: GSK3052230
A clear to opalescent, colorless to pale yellow solution for IV infusion once weekly (Day 1, Day 8, Day 15) in each 21-day cycle with unit dose strengths/dose level of 5, 10, 15, and 20 mg/kg supplied in a sterile 25 mL glass vial.
Drug: paclitaxel
paclitaxel will be from commercial stock.
Drug: carboplatin
carboplatin will be from commercial stock.
Experimental: Arm B: GSK3052230 + docetaxel
Subject will receive GSK3052230 as 30-minute intravenous (i.v.) infusion once a week (Day 1, Day 8, Day 15) of each 21-day cycle + docetaxel as 1 hour iv infusion on Day 1 of each 21-day cycle. Subjects may continue to receive docetaxel until disease progression or as long as they are considered to derive benefit from treatment.
Drug: GSK3052230
A clear to opalescent, colorless to pale yellow solution for IV infusion once weekly (Day 1, Day 8, Day 15) in each 21-day cycle with unit dose strengths/dose level of 5, 10, 15, and 20 mg/kg supplied in a sterile 25 mL glass vial.
Drug: docetaxel
docetaxel will be from commercial stock.
Experimental: Arm C: GSK3052230 + pemetrexed and cisplatin
Subject will receive GSK3052230 as 30 minute iv infusion once a week (Day 1, Day 8, Day 15) of each 21 day cycle + pemetrexed iv infusion over 10 minutes on Day 1 of each 21 day cycle followed 30 minutes later by iv Cisplatin infused over 2 hours
Drug: GSK3052230
A clear to opalescent, colorless to pale yellow solution for IV infusion once weekly (Day 1, Day 8, Day 15) in each 21-day cycle with unit dose strengths/dose level of 5, 10, 15, and 20 mg/kg supplied in a sterile 25 mL glass vial.
Drug: pemetrexed
pemetrexed will be from commercial stock
Drug: cisplatin
cisplatin will be from commercial stock

  Eligibility

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

Inclusion Criteria

  • Signed written informed consent
  • Histologically or cytologically confirmed diagnosis: Arm A and B- stage IV recurrent metastatic squamous NSCLC with Fibroblast growth factor receptor 1 (FGFR1) gene amplification by central laboratory testing. Arm C- recurrent after local therapy or unresectable MPM with measurable lesions.

For specific arms the following requirements:

Arm A: Subjects who have received no prior therapy for Stage IV or recurrent metastatic disease. Note, to avoid any undue delay of initiating systemic chemotherapy for these subjects with newly diagnosed metastatic disease, it is allowed to initiate the first cycle of chemotherapy while eligibility for the study is still being determined, as long as the first dose of GSK3052230 is given no later than Cycle 2 Day 1 of chemotherapy. In addition, subjects with Stage IV disease and recurrence after previous NSCLC that has been treated with surgery and adjuvant chemotherapy or a radio- chemotherapy regimen with curative intent are eligible, provided 6 months has passed since this treatment ended.

Arm B: Subjects who have documented tumor progression (based on radiological imaging) or intolerability after receiving only one prior line of platinum containing combination chemotherapy for Stage IV or recurrent metastatic disease. Continued 'maintenance' chemotherapy will be considered part of the first line regimen if the same agents are used. If new agents are used for maintenance treatment, this will be considered a second line of therapy. Note: first line treatment should not include docetaxel but may have included paclitaxel.

Arm C: Subjects who have received no prior systemic therapy for MPM.

- Availability of archival tumor tissue required for assessment of deregulated FGF pathway signaling e.g. FGFR1 amplification or FGF2 expression. If archival tissue is not available, a fresh biopsy is required. In Arms A and B, subjects will be prospectively screened for FGFR1 gene amplification using a Fluorescence in situ hybridization (FISH) assay. For inclusion in this study, based on the central laboratory testing, FGFR1 gene amplification must meet one of the following criteria: a ratio of FGFR1/CEN 8 of >=2; or average number of FGFR1 signals per tumor nucleus of >=6; or the percentage of tumor nuclei containing >=5 FGFR1 signals is >=50%.

In Arm C, FGF2 expression by IHC will be evaluated retrospectively in tissue samples by a central laboratory and is not a requirement for study entry.

  • Measurable disease per RECIST version 1.1
  • Male or female >=18 years of age.
  • Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use effective contraception, from 14 days prior to the first dose of study treatment, throughout the study, and for 6 months following the last dose of chemotherapy or 4 weeks after the last dose of GSK3052230, whichever is latest. .
  • Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception for at least 2 weeks prior to administration of the first dose of study treatment and for at least 6 months after the last dose of chemotherapy to allow for clearance of any altered sperm.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 for Arm A subjects and 0-2 for Arms B and C
  • French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category
  • Must have adequate organ function as defined by the following baseline values: Absolute neutrophil count >=1.5 x 10^9/Liter, Hemoglobin >=10 gram (g)/decilitre(dL), Platelets >=100 x 10^9/L, Partial thromboplastin time (PTT) <=1.25 x upper limit of normal (ULN), Albumin >=2.5 g/dL, Serum bilirubin <=1.25 times ULN (for Arm B: <=ULN ), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <=2.5 times ULN (for Arm B: <=1.5 times ULN), Serum Creatinine <=1.5 x ULN, Or Measured or Calculated Creatinine Clearance >=45 mL/min, Left ventricular ejection fraction >=lower limit of normal (LLN).

Exclusion Criteria

  • For Arms A, B, C: Treatment with any FGFR inhibitor. For Arms B, C: Treatment with any anti-cancer therapy (for biological anti-cancer therapies see criteria below.) during the preceding 4 weeks or within 4 half-lives of the therapy, whichever is longer.
  • Receipt of any biological therapy within 6 weeks of the first dose of GSK3052230
  • Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 (NCI CTCAE version 4.03) Grade 2 or higher from previous anti-cancer therapy, except alopecia.
  • Active malignancy other than the cancer under study. Subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
  • Presence of uncontrolled infection
  • Prior major surgery or trauma within 28 days before first dose of study drug
  • Presence of any non-healing wound, fracture, or ulcer
  • Any prohibited medication(s) as described in protocol
  • Conditions likely to increase the potential for abdominal perforation or fistula formation, including but not limited to:

Luminal intestinal cancers or bulky abdominal disease. Presence or history of abdominal fistula, gastrointestinal perforation, peptic ulcer disease or intra-abdominal abscess within the six months prior to the first dose of GSK3052230.

Other risk factors for perforation, such as acute diverticulitis, obstruction or previous abdominal or pelvic radiation.

  • Symptomatic leptomeningeal or brain metastases or spinal cord compression Note: Subjects previously treated for these conditions are eligible if they meet following two criteria: (1) have had stable CNS disease for at least 4 weeks after local therapy as assessed by imaging (contrast enhanced magnetic resonance imaging (MRI) or computed tomography (CT)), and (2) are asymptomatic and off corticosteroids, or are on stable dose of corticosteroids for at least 4 weeks prior to Day 1..
  • Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drugs (GSK3052230, docetaxel, paclitaxel, carboplatin, pemetrexed, cisplatin) and or their excipients that contraindicate their participation.
  • Known human immunodeficiency virus-positive serology, acquired immunodeficiency syndrome (AIDS), or an AIDS-related illness.
  • Prior organ or allogeneic stem cell transplant
  • The following cardiac abnormalities:

Corrected QT (QTc) interval >=480 millisecond. History of acute coronary syndromes (including unstable angina) within the past 24 weeks Coronary angioplasty or stenting within the past 24 weeks. Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.

Abnormal cardiac valve morphology (>= Grade 2) documented by echocardiogram (subjects with Grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study).

History of known arrhythmias (except sinus arrhythmia and atrial fibrillation that is controlled) within the past 24 weeks.

  • Presence or history of hemoptysis (>1/2 teaspoon of red blood) 2 weeks prior to the first dose of GSK3052230
  • Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.
  • Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per investigator's assessment).
  • Pregnant, lactating or actively breast feeding females.
  • French subjects: The French subject has participated in any study using an investigational study treatment(s) during the previous 30 days.
  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: NCT01868022

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
United States, Arizona
GSK Investigational Site Terminated
Scottsdale, Arizona, United States, 85258
United States, California
GSK Investigational Site Not yet recruiting
Duarte, California, United States, 91010
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Not yet recruiting
Sacramento, California, United States, 95817
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Michigan
GSK Investigational Site Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Missouri
GSK Investigational Site Recruiting
St. Louis, Missouri, United States, 63110
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, New York
GSK Investigational Site Not yet recruiting
New York, New York, United States, 10065
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, North Carolina
GSK Investigational Site Completed
Chaple Hill, North Carolina, United States, 27599-7305
Belgium
GSK Investigational Site Recruiting
Leuven, Belgium, 3000
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Denmark
GSK Investigational Site Recruiting
Koebenhavn Oe, Denmark, 2100
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
France
GSK Investigational Site Recruiting
Marseille Cedex 5, France, 13385
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Toulouse Cedex 9, France, 31059
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Russian Federation
GSK Investigational Site Recruiting
St. Petersburg, Russian Federation, 197758
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Not yet recruiting
St. Petersburg, Russian Federation, 197 089
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Spain
GSK Investigational Site Recruiting
Badajoz, Spain, 06080
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Barcelona, Spain, 08035
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Not yet recruiting
Barcelona, Spain, 08028
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Madrid, Spain, 28034
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Málaga, Spain, 29010
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Sevilla, Spain, 41013
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United Kingdom
GSK Investigational Site Not yet recruiting
London, United Kingdom, W1G 6AD
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01868022     History of Changes
Other Study ID Numbers: 117360
Study First Received: May 30, 2013
Last Updated: August 14, 2014
Health Authority: France: National Agency for the Safety of Medicine and Health Products
Denmark: Danish Medicines Agency
Spain: Spanish Agency for Medicines and Health Products
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
FGFR1
FP1039
GSK3052230
docetaxel
FGFR
carboplatin
HGS1036
squamous non-small cell lung cancer
paclitaxel

Additional relevant MeSH terms:
Docetaxel
Pemetrexed
Cisplatin
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on August 27, 2014