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Cancer of CervixPhase 1NCT02312804

Ph Ib/BGJ398/Cervix and Other Solid Tumors

A Phase 1 study testing BGJ398, Carboplatin and Paclitaxel in people with Cancer of Cervix and Tumors, run by The University of Texas Health Science Center at San Antonio.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study will be conducted using 3+3 design and includes, a dose escalation part to define the MTDfRP2D for the combination of BGJ398 and carboplatin/paclitaxel, and a dose expansion part to treat another 12 patients (only cervix cancer) to further evaluate safety of this combination. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer of Cervix, Tumors
What is being tested?
BGJ398, Carboplatin and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2015to Jan 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects age >18 years at the time of informed consent
  • Histologically/cytologically confirmed locally advanced or metastatic solid tumors for which no curable therapy exists. In dose expansion part of this study, only patients with stage IV or recurrent/persistent cervical cancer will be enrolled. Confirmation of FGF/FGFR aberration is not required.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Adequate marrow function as defined below:
  • absolute neutrophil count ≥ 1.5 x 10 9/L platelets ≥ 100,000 x 10 9/L hemoglobin ≥ 9.0 g/dL Adequate liver function as evidenced by bilirubin <1.5 times the upper limit of normal (ULN); alanine aminotransferase (AL T) and aspartate aminotransferase (AST) <3 times the ULN
  • Evidence of measurable or evaluable disease, as determined by RECIST v 1.1
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: has not undergone a hysterectomy or bilateral oophorectomy, or has not been naturally postmenopausal for at least 12 consecutive months (Le., has had menses at any time in the preceding 12 consecutive months). Oral contraceptives (OC), injected or implanted hormonal methods are not allowed as the sole method of contraception because BGJ398 has not been characterized with respect to its potential to interfere with PK and/or the effectiveness of OCs.
  • It is preferred that archival tumor sample is available for molecular testing, if not available, a newly obtained tumor biopsy may be submitted instead (not mandatory)

Who cannot join

  • For patients enrolled in dose escalation, any number of prior treatments allowed. For patients enrolled in dose expansion, no prior chemotherapy is allowed (previous single agent cisplatin concurrent with radiotherapy is accepted).
  • No prior therapy with paclitaxel, BGJ398 or other FGFR targeting agents.
  • Preexisting> grade 2 peripheral neuropathy
  • Patients with brain metastases are allowed provided that they are clinically stable for a period of 30 days prior to study entry and there is not a requirement for steroids or anti epileptics.
  • History of pancreatitis in last 6 months prior to enrollment.
  • History and/or current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis, or patients with other phosphate regulating abnormalities. Because hyperphosphatemia is a frequent occurrence with BGJ398 treatment, pretreatment and concurrent treatment with phosphate regulating agents is allowed.
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  • Current evidence of corneal or retinal disorder/ keratopathy such as bullous/ band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivits, etc
  • Since BGJ398 is a likely inhibitor of CYP3A4, patients who are currently receiving treatment with agents that are known sting inducers or inhibitors CYP3A4 are not allowed
  • Treatment with any of the following anti-cancer therapies prior to the first dose of the of BGJ398 within the stated timeframes: intravenous chemotherapy within a period of 4 weeks ( 6 weeks for nitrosourea, mitomycin-C), biological therapy (e,g. antibodies) within a period of time that is ~ 5 t1/2 or less than 4 weeks, whichever is shorter, prior to starting study drug, any other investigational agents within a period of time that is < 5 tl/2 or 4 weeks (whichever is shortest) prior to starting study drug, wide field radiotherapy < 4 weeks or limited field radiation for palliation < 2 weeks prior to starting study drug.
  • Use of medications that increase serum levels of phosphorus and/or calcium.
  • History of cardiac disease (Congestive heart failure NYHA grade> 2, LVEF < 50% as determined by MUGA scan or ECHO, history of clinically significant ventricular arrhythmias, unstable angina pectoriS or acute myocardial infarction <6 months prior to starting study drug, QTcF > 450 msec)
  • Pregnant or nursing (lactating) women.

About this study

Official title: A Phase Ib Study Evaluating BGJ398 in Combination With Chemotherapeutic Regimen in Patients With Stage IV, Recurrent or Persistent Carcinoma of The Cervix and Other Solid Tumors

This study will be conducted using 3+3 design and includes, a dose escalation part to define the MTDfRP2D for the combination of BGJ398 and carboplatin/paclitaxel, and a dose expansion part to treat another 12 patients (only cervix cancer) to further evaluate safety of this combination. Safety, tolerability and MTD will be determined in the dose escalation part of the study. The dose expansion will additionally investigate preliminary anti-tumor efficacy in cervical cancer. The dosing cycle is 21 days.

Being tested
BGJ398, Carboplatin, Paclitaxel
Medical subject headings
Uterine Cervical Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BGJ398Drug

    Also called BGJ 398

    BGJ398 will be administered orally once daily on each day of the 21 day cycle.

  • CarboplatinDrug

    Also called Paraplatin

    Carboplatin will be administered in combination with paclitaxel intravenously on the first day of each 21-day cycle.

  • PaclitaxelDrug

    Also called Taxol

    Paclitaxel will be administered in combination with carboplatin intravenously on the first day of each 21-day cycle.

Study groups in NCT02312804
Study groupRoleWhat they receive
Dose EscalationExperimentalTo determine the MTD/RP2D of BGJ398 when combined with carboplatin and paclitaxel in subjects with locally advanced for metastatic solid tumors.
Receives: Drug: BGJ398; Drug: Carboplatin; Drug: Paclitaxel
Expansion Cervical CancerExperimentalTo assess the anti-tumor effect of BGJ398 when combined with carboplatin and paclitaxel in cervix cancer.
Receives: Drug: BGJ398; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the maximum tolerated dose (MTD) based on toxicity analysis.

    Toxicity will be monitored according to NCI Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0.

    Measured: approximately 12 months

Secondary outcomes (1)

  1. Time vs. concentration profile of BGJ398

    Plasma concentration versus time profiles. Plasma PK parameters will be used to characterize the PK profiles of BGJ398 when combined with certain chemotherapies.

    Measured: At Cycle 1 Day 1 and Cycle 2 Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionJan 2015
  4. Study completionJan 2015

Why it stopped: Drug not available.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02312804
Sponsor's protocol ID
CTMS 14-2006
Status last verified
Feb 2015
First submitted
1 Oct 2014
Last updated
16 Feb 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BGJ398, Carboplatin and Paclitaxel in people with Cancer of Cervix and Tumors, run by The University of Texas Health Science Center at San Antonio.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the maximum tolerated dose (MTD) based on toxicity analysis. (time frame: approximately 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02312804.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2015.

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