Solid TumorsPhase 1NCT02620839
Phase Ib Study of Alpelisib With Cisplatin in Patients With HPV+ Solid Tumor Malignancies
A Phase 1 study testing Alpelisib and Cisplatin in people with Solid Tumors, run by Pamela Munster at 1 site in United States.
Trial summary
This phase Ib trial studies the best dose and side effects of alpelisib and cisplatin in treating patients with human papillomavirus (HPV) positive solid tumor malignancies. Alpelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Alpelisib and Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2016to 28 Jan 2019
- 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
- Able to understand and voluntarily sign the informed consent form, and able to comply with the study visit schedule and other protocol requirements. Written informed consent obtained prior to any screening procedures.
- Age ≥ 18 years.
- Dose escalation:
- Any locally advanced or metastatic solid tumor malignancy with no curative treatment options available
- Dose expansion:
- HPV-associated locally advanced or metastatic platinum-resistant solid tumor malignancy. HPV positivity defined by positive p16 immunohistochemistry or in-situ hybridization assessment of archival tissue (primary or metastatic) in a CLIA-certified laboratory. Availability of pathology report from CLIA-certified lab demonstrating positive HPV status by p16 IHC or in situ hybridization qualifies for eligibility determination. Analysis of fresh tumor tissue is permitted in cases where archival tissue is not available.
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- Platinum resistance defined as prior progression (radiographic or clinical) either during or within 6 months following completion of platinum-based chemotherapy.
- Platinum-based therapy as most recent systemic therapy prior to enrollment allowed but not required
- Patients may have received any number of lines of prior systemic therapy for locally advanced/metastatic disease.
- Eastern Cooperative Oncology Group performance status ≤ 1
- Patient has adequate bone marrow and organ function as defined by the following laboratory values:
- Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Hemoglobin ≥ 9.0 g/dL
- Serum creatinine < 1.5 x ULN OR Estimated GFR by Cockroft-Gault equation OR 24 hour urine collection ≥ 60 ml/min
- Total serum bilirubin ≤ 1.5 x ULN (< 3 x ULN in patients with documented/suspected Gilbert's disease with concomitant direct bilirubin ≤ 1.5 x ULN)
- Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤ 2.5 x ULN (or ≤ 5 x ULN if liver metastases are present)
- Fasting plasma glucose (FPG) ≤ 140mg/dL or 7.8 mmol/L
- Hemoglobin A1c < 7%
- Patient is able to swallow oral medications.
- Measurable or evaluable disease by RECIST 1.1 in dose escalation. Measurable disease by RECIST 1.1 is required in dose expansion.
- Recovery from all AEs of previous anti-cancer therapies, including surgery, chemotherapy and radiotherapy, to baseline or to CTCAE Grade ≤ 1, except for alopecia.
Who cannot join
- Prior treatment with PI3K-inhibitor.
- Prior known hypersensitivity to any of the excipients of alpelisib.
- Grade ≥ 2 peripheral neuropathy.
- Grade ≥ sensorineural hearing loss.
- Patients with uncontrolled CNS metastatic involvement. However, patients with metastatic CNS tumors may participate in this study if the patient is:
- > 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment
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- Clinically stable with respect to the CNS tumor at the time of screening
- Not receiving steroid therapy
- Not receiving anti-convulsive medications that were started for brain metastases.
- Patients who have received prior systemic anti-cancer treatment within 4 weeks or 5 half-lives of prior to starting study treatment, whichever is shorter.
- Prior investigational therapy within 4 weeks of start of study treatment.
- Patients who have received radiotherapy ≤ 2 weeks prior to starting study drugs, with exception of palliative radiotherapy, who have not recovered from side effects of such therapy to baseline or Grade ≤ 1 and/or from whom ≥ 30% of the bone marrow was irradiated.
- Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed
- Patients who have undergone major surgery ≤ 4 weeks prior to starting study treatment or who have not recovered from side effects of such procedure.
- Clinically significant cardiac disease or impaired cardiac function, such as:
- Congestive heart failure (CHF) requiring treatment (New York Heart Association (NYHA) Grade ≥ 2) or left ventricular ejection fraction (LVEF) < 50% as determined by multi-gated acquisition (MUGA) scan or echocardiogram (ECHO) at screening
- History or current evidence of clinically significant cardiac arrhythmias, atrial fibrillation and/or conduction abnormality, e.g. congenital long QT syndrome, high- grade/complete AV-blockage
- Acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass graft [CABG], coronary angioplasty, or stenting), < 3 months prior to screening
- QT interval adjusted according to Fredericia (QTcF) > 480 msec on screening ECG
- Patients with diabetes mellitus requiring insulin treatment or uncontrolled steroid-induced diabetes mellitus.
- Any other condition that would, in the Investigator's judgment, preclude patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g. infection/inflammation, intestinal obstruction, social/psychological complications.
- Impaired GI function or GI disease that may significantly alter the absorption of oral alpelisib (e.g. Uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or significant small bowel resection).
- Patients who are currently receiving medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes (TdP) and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug treatment. A list of prohibited drugs with a known risk of TdP is provided in Appendix.
- Patient is currently receiving treatment with drugs known to be strong inhibitors or inducers of isoenzyme CYP3A. The patient must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the start of treatment. Switching to a different medication is allowed. (Refer to Appendix)
- Known positive serology for human immunodeficiency virus (HIV) (baseline testing not required)
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
- Patient who does not apply highly effective contraception during the study and through the duration as defined below after the final dose of study treatment:
- Sexually active males should use a condom during intercourse while taking drug and for 16 weeks after the final dose of study treatment and should not father a child in this period, but may be recommended to seek advice on conservation of sperm. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during the study and through at least 16 weeks after the final dose of study treatment. Highly effective contraception is defined as either:
- Total abstinence: When this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception].
- Female sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
- Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). [For female study subjects, the vasectomized male partner should be the sole partner for that patient].
- Use a combination of the following (both a+b):
- Placement of an intrauterine device (IUD) or intrauterine system (IUS) Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
- Note: Hormonal contraception methods (e.g. oral, injected, and implanted) are not allowed Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago.
- For women with therapy-induced amenorrhea, oophorectomy or serial measurements of FSH and/or estradiol are needed to ensure postmenopausal status.
- NOTE: Ovarian radiation or treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143-1711
About this study
Official title: A Phase Ib, Open-label Study of Alpelisib (BYL719) in Combination With Cisplatin in Patients With HPV+ Solid Tumor Malignancies
This phase Ib trial studies the best dose and side effects of alpelisib and cisplatin in treating patients with human papillomavirus (HPV) positive solid tumor malignancies. Alpelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving alpelisib and cisplatin may work better in treating patients with solid tumor malignancies.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the maximally tolerated dose and recommended phase 2 dose of alpelisib in combination with weekly cisplatin.
SECONDARY OBJECTIVES:
- To determine the objective response rate and median progression-free survival with the treatment combination in HPV positive (+) solid tumor malignancies.
II. To characterize the safety profile of the combination.
OUTLINE: This is a dose escalation study.
Patients receive alpelisib orally (PO) once daily (QD) on days 1-14 or 1-21, and cisplatin intravenously (IV) over 1-2 hours on days 1 and 8, or days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
- Conditions
- Solid Tumors
- Being tested
- Alpelisib, Cisplatin
- Keywords
- CDKN2A-p16 Positive, Locally Advanced Solid Neoplasm, Metastatic Malignant Solid Neoplasm
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlpelisibDrug
Given PO
CisplatinDrug
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1A | Experimental | Alpelisib: 200 mg/day, orally, days 1-21 Cisplatin: 30 mg/m^2, intravenously, days 1, 8, 15 Receives: Drug: Alpelisib; Drug: Cisplatin |
| Cohort 2A | Experimental | Alpelisib: 250 mg/day, orally, days 1-21 Cisplatin: 30 mg/m^2, intravenously, days 1, 8, 15 Receives: Drug: Alpelisib; Drug: Cisplatin |
| Cohort 2B | Experimental | Alpelisib: 250 mg/day, orally, days 1-21 Cisplatin: 35 mg/m^2, intravenously, days 1, 8, 15 Receives: Drug: Alpelisib; Drug: Cisplatin |
| Cohort 3A | Experimental | Alpelisib: 300 mg/day, orally, days 1-21 Cisplatin: 30 mg/m^2, intravenously, days 1, 8, 15 Receives: Drug: Alpelisib; Drug: Cisplatin |
| Cohort 3B | Experimental | Alpelisib: 300 mg/day, orally, days 1-21 Cisplatin: 35 mg/m^2, intravenously, days 1, 8, 15 Receives: Drug: Alpelisib; Drug: Cisplatin |
| Cohort 4A | Experimental | Alpelisib: 350 mg/day, orally, days 1-21 Cisplatin: 30 mg/m^2, intravenously, days 1, 8, 15 Receives: Drug: Alpelisib; Drug: Cisplatin |
| Cohort 4B | Experimental | Alpelisib: 350 mg/day, orally, days 1-21 Cisplatin: 35 mg/m^2, intravenously, days 1, 8, 15 Receives: Drug: Alpelisib; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximally tolerated dose of alpelisib in combination with cisplatin, based upon evaluation of dose-limiting toxicities and adverse events
Measured using CTCAE v.4.03
Measured: Up to 21 days
Recommended phase 2 dose of alpelisib in combination with cisplatin, based upon evaluation of dose-limiting toxicities
Measured using CTCAE v.4.03
Measured: Up to 30 days after the last administration of the study treatment
Secondary outcomes (4)
Objective Response Rate
RECIST v.1.1
Measured: Up to 30 days after the last administration of the study treatment
Median duration of response
RECIST v.1.1
Measured: Up to 30 days after the last administration of the study treatment
Median Progression-Free Survival
RECIST v.1.1
Measured: Up to 30 days after the last administration of the study treatment
Incidence of adverse events of the treatment combination
CTCAE v.4.03
Measured: Up to 30 days after the last administration of the study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study start1 Dec 2016
- Primary completion28 Jan 2019
- Study completion28 Jan 2019
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Factorial
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamela Munster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pamela Munster, University of California, San Francisco
- Investigators
- Pamela Munster, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620839
- Sponsor's protocol ID
- 159516
- Other IDs
- NCI-2017-01680
- Status last verified
- Jan 2020
- First submitted
- 1 Dec 2015
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open-label Study of Alpelisib (BYL719) in Combination With Cisplatin in Patients With HPV+ Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT02620839
- Acronym / sponsor ID
- 159516
- Conditions
- Solid Tumors
- Keywords
- CDKN2A-p16 Positive, Locally Advanced Solid Neoplasm, Metastatic Malignant Solid Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Pamela MunsterUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 3 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase Ib trial studies the best dose and side effects of alpelisib and cisplatin in treating patients with human papillomavirus (HPV) positive solid tumor malignancies. Alpelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving alpelisib and cisplatin may work better in treating patients with solid tumor malignancies.
Detailed description
PRIMARY OBJECTIVES:
- To determine the maximally tolerated dose and recommended phase 2 dose of alpelisib in combination with weekly cisplatin.
SECONDARY OBJECTIVES:
- To determine the objective response rate and median progression-free survival with the treatment combination in HPV positive (+) solid tumor malignancies.
II. To characterize the safety profile of the combination.
OUTLINE: This is a dose escalation study.
Patients receive alpelisib orally (PO) once daily (QD) on days 1-14 or 1-21, and cisplatin intravenously (IV) over 1-2 hours on days 1 and 8, or days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1A | Experimental | Drug: Alpelisib, Drug: CisplatinAlpelisib: 200 mg/day, orally, days 1-21 Cisplatin: 30 mg/m^2, intravenously, days 1, 8, 15 |
| Cohort 2A | Experimental | Drug: Alpelisib, Drug: CisplatinAlpelisib: 250 mg/day, orally, days 1-21 Cisplatin: 30 mg/m^2, intravenously, days 1, 8, 15 |
| Cohort 2B | Experimental | Drug: Alpelisib, Drug: CisplatinAlpelisib: 250 mg/day, orally, days 1-21 Cisplatin: 35 mg/m^2, intravenously, days 1, 8, 15 |
| Cohort 3A | Experimental | Drug: Alpelisib, Drug: CisplatinAlpelisib: 300 mg/day, orally, days 1-21 Cisplatin: 30 mg/m^2, intravenously, days 1, 8, 15 |
| Cohort 3B | Experimental | Drug: Alpelisib, Drug: CisplatinAlpelisib: 300 mg/day, orally, days 1-21 Cisplatin: 35 mg/m^2, intravenously, days 1, 8, 15 |
| Cohort 4A | Experimental | Drug: Alpelisib, Drug: CisplatinAlpelisib: 350 mg/day, orally, days 1-21 Cisplatin: 30 mg/m^2, intravenously, days 1, 8, 15 |
| Cohort 4B | Experimental | Drug: Alpelisib, Drug: CisplatinAlpelisib: 350 mg/day, orally, days 1-21 Cisplatin: 35 mg/m^2, intravenously, days 1, 8, 15 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Able to understand and voluntarily sign the informed consent form, and able to comply with the study visit schedule and other protocol requirements. Written informed consent obtained prior to any screening procedures.
- Age ≥ 18 years.
- Dose escalation:
- Any locally advanced or metastatic solid tumor malignancy with no curative treatment options available
- Dose expansion:
Key exclusion criteria (37 listed)
- Prior treatment with PI3K-inhibitor.
- Prior known hypersensitivity to any of the excipients of alpelisib.
- Grade ≥ 2 peripheral neuropathy.
- Grade ≥ sensorineural hearing loss.
- Patients with uncontrolled CNS metastatic involvement. However, patients with metastatic CNS tumors may participate in this study if the patient is:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlpelisibGiven PO | Drug | Cohort 1A, Cohort 2A, Cohort 2B, Cohort 3A, Cohort 3B, Cohort 4A, Cohort 4B |
| CisplatinGiven IV | Drug | Cohort 1A, Cohort 2A, Cohort 2B, Cohort 3A, Cohort 3B, Cohort 4A, Cohort 4B |
Primary outcome
Maximally tolerated dose of alpelisib in combination with cisplatin, based upon evaluation of dose-limiting toxicities and adverse events
Time frame: Up to 21 days
Measured using CTCAE v.4.03
Recommended phase 2 dose of alpelisib in combination with cisplatin, based upon evaluation of dose-limiting toxicities
Time frame: Up to 30 days after the last administration of the study treatment
Measured using CTCAE v.4.03
4 secondary outcomes
Objective Response Rate
Time frame: Up to 30 days after the last administration of the study treatment
Median duration of response
Time frame: Up to 30 days after the last administration of the study treatment
Median Progression-Free Survival
Time frame: Up to 30 days after the last administration of the study treatment
Incidence of adverse events of the treatment combination
Time frame: Up to 30 days after the last administration of the study treatment
Results and safety
The study was stopped early (reason given: Funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Munster, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alpelisib and Cisplatin in people with Solid Tumors, run by Pamela Munster at 1 site in United States.
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 22 inclusion and 37 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: stopped early, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Funding). Results are not available in the source record.
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?
Maximally tolerated dose of alpelisib in combination with cisplatin, based upon evaluation of dose-limiting toxicities and adverse events (time frame: Up to 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2020.